Remote management of heart failure using implantable electronic devices A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices. Optimising self-care support for people with heart failure and their caregivers: development of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention using intervention mapping Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial Use of Remote Monitoring to Improve Outcomes in Patients with Heart Failure: A Pilot Trial Telemedical Interventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design. Home telemonitoring of vital signs and cardiorespiratory signals in heart failure patients: system architecture and feasibility of the HHH model. Device monitoring strategies in acute heart failure syndromes Automated home telephone self-monitoring reduces hospitalization in patients with advanced heart failure "I am not alone": the feasibility and acceptability of interactive voice response-facilitated telephone peer support among older adults with heart failure. Cost of medical services in older patients with heart failure: those receiving enhanced monitoring using a computer-based telephonic monitoring system compared with those in usual care: the Heart Failure Home Care trial. Impact of Home Patient Telemonitoring on Use of β-Blockers in Congestive Heart Failure Assessment of a primary care-based telemonitoring intervention for home care patients with heart failure and chronic lung disease. The TELBIL study Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial A telephone-delivered empowerment intervention with patients diagnosed with heart failure. Lack of improvement of clinical outcomes by a low-cost, hospital-based heart failure management programme Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial [Noninvasive remote telemonitoring for ambulatory patients with heart failure: effect on number of hospitalizations, days in hospital, and quality of life. CARME (CAtalan Remote Management Evaluation) study]. Education and telephone monitoring by nurses of patients with heart failure: randomized clinical trial. Association of Discharge Summary Quality With Readmission Risk for Patients Hospitalized With Heart Failure Exacerbation Heart Failure 2012 Pilot Testing of a Multicomponent Home Care Intervention for Older Adults With Heart Failure: An Academic Clinical Partnership Outcomes of chronic heart failure. Cost-Utility Analysis of the EVOLVO Study on Remote Monitoring for Heart Failure Patients With Implantable Defibrillators: Randomized Controlled Trial Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice Randomized trial of Telemonitoring to Improve Heart Failure Outcomes (Tele-HF): study design. Use of Home Telemonitoring to Support Multidisciplinary Care of Heart Failure Patients in Finland: Randomized Controlled Trial Can monitoring of intrathoracic impedance reduce morbidity and mortality in patients with chronic heart failure? Rationale and design of the Diagnostic Outcome Trial in Heart Failure (DOT-HF). Design and performance of a multisensor heart failure monitoring algorithm: results from the multisensor monitoring in congestive heart failure (MUSIC) study. Insights from internet-based remote intrathoracic impedance monitoring as part of a heart failure disease management program. CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system. Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics) A systematic review of the effectiveness of nurse coordinated transitioning of care on readmission rates for patients with heart failure Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death: the Trans-European Network-Home-Care Management System (TEN-HMS) study. A randomized trial of home telemonitoring in a typical elderly heart failure population in North West London: results of the Home-HF study. Does Home Telemonitoring after Pulmonary Rehabilitation Reduce Healthcare Use in Optimized COPD?? A Pilot Randomized Trial The effectiveness of telephone‐based post‐discharge nursing care in decreasing readmission rate in patients with heart failure: a systematic review INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact) Unrecognized Cognitive Impairment and Its Effect on Heart Failure Readmissions of Elderly Adults. Telephone support to rural and remote patients with heart failure: the Chronic Heart Failure Assessment by Telephone (CHAT) study. Linking clinic and home: a randomized, controlled clinical effectiveness trial of real-time, wireless blood pressure monitoring for older patients with kidney disease and hypertension A multicenter disease management program for hospitalized patients with heart failure. Health-related quality of life in a multicenter randomized controlled comparison of telephonic disease management and automated home monitoring in patients recently hospitalized with heart failure: SPAN-CHF II trial. Home-based disease management program to improve psychological status in patients with heart failure in Japan. Cost-effectiveness of a nurse-led education and psychosocial programme for patients with chronic heart failure and their partners. A randomized clinical trial of the clinical effects of enhanced heart failure monitoring using a computer-based telephonic monitoring system in older minorities and women. Economic evaluation of telephone self-management interventions for blood pressure control. Randomized clinical trial of an integrated self-care intervention for persons with heart failure and diabetes: quality of life and physical functioning outcomes. Cost/utility ratio in chronic heart failure: comparison between heart failure management program delivered by day-hospital and usual care. Reducing the Cost of Frequent Hospital Admissions for Congestive Heart Failure: A Randomized Trial of a Home Telecare Intervention Added value of a physician-and-nurse-directed heart failure clinic: results from the Deventer–Alkmaar heart failure study Telemonitoring of heart failure patients and their caregivers: a pilot randomized controlled trial. Effect of a telemonitoring-facilitated collaboration between general practitioner and heart failure clinic on mortality and rehospitalization rates in severe heart failure: the TEMA-HF 1 (TElemonitoring in the MAnagement of Heart Failure) study. Impact of telemonitoring home care patients with heart failure or chronic lung disease from primary care on healthcare resource use (the TELBIL study randomised controlled trial) Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study. Home-based telemonitored Nordic walking training is well accepted, safe, effective and has high adherence among heart failure patients, including those with cardiovascular implantable electronic devices: a randomised controlled study Telemonitoring in patients with heart failure, the TEHAF study: Study protocol of an ongoing prospective randomised trial. Outcomes of a home telehealth intervention for patients with heart failure Nurse-Led Multidisciplinary Heart Failure Group Clinic Appointments: Methods, Materials, and Outcomes Used in the Clinical Trial The impact of remote patient monitoring (telehealth) upon Medicare beneficiaries with heart failure. Self-management support using an Internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial Interdisciplinary model of care (RADICALS) for early detection and management of chronic obstructive pulmonary disease (COPD) in Australian primary care: study protocol for a cluster randomised controlled trial Clinical trials update from the European Society of Cardiology Heart Failure meeting 2011: TEHAF, WHICH, CARVIVA, and atrial fibrillation in GISSI-HF and EMPHASIS-HF. Swiss Interdisciplinary Management Programme for Heart Failure (SWIM-HF): a randomised controlled trial study of an outpatient inter-professional management programme for heart failure patients in Switzerland. Tailored Telemonitoring in patients with heart failure: results from a multicentre randomized controlled trial (the TEHAF-study) Clinical Effectiveness, Access to, and Satisfaction with Care Using a Telehomecare Substitution Intervention: A Randomized Controlled Trial Impact of Remote Telemedical Management on Mortality and Hospitalizations in Ambulatory Patients With Chronic Heart Failure: The Telemedical Interventional Monitoring in Heart Failure Study Telemonitoring in Chronic Obstructive Pulmonary Disease (CHROMED). A Randomized Clinical Trial Point-of-Care International Normalized Ratio (INR) Monitoring Devices for Patients on Long-term Oral Anticoagulation Therapy: An Evidence-Based Analysis. Telemonitoring with case management for seniors with heart failure. Advanced practice nurse strategies to improve outcomes and reduce cost in elders with heart failure. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial Evaluation of home telehealth following hospitalization for heart failure: a randomized trial. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers. Clinical effectiveness and cost-effectiveness of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) facilitated self-care rehabilitation intervention in heart failure patients and caregivers: rationale and protocol for a multicentre randomised controlled trial Assessment of an enhanced program for depression management in primary care: a cluster randomized controlled trial. The INDI project (Interventions for Depression Improvement) Addition of Supervised Exercise Training to a Post-Hospital Disease Management Program for Patients Recently Hospitalized With Acute Heart Failure: The EJECTION-HF Randomized Phase 4 Trial. Adherence, adaptation and acceptance of elderly chronic heart failure patients to receiving healthcare via telephone-monitoring. Telemonitoring-based service redesign for the management of uncontrolled hypertension (HITS): cost and cost-effectiveness analysis of a randomised controlled trial Secondary Prevention Risk Interventions Via Telemedicine and Tailored Patient Education (SPRITE): A Randomized Trial to Improve Postmyocardial Infarction Management A multicenter randomized controlled evaluation of automated home monitoring and telephonic disease management in patients recently hospitalized for congestive heart failure: the SPAN-CHF II trial. The Patient Remote Intervention and Symptom Management System (PRISMS) – a Telehealth- mediated intervention enabling real-time monitoring of chemotherapy side-effects in patients with haematological malignancies: study protocol for a randomised controlled trial Rehabilitation Enablement in Chronic Heart Failure—a facilitated self-care rehabilitation intervention in patients with heart failure with preserved ejection fraction (REACH-HFpEF) and their caregivers: rationale and protocol for a single-centre pilot randomised controlled trial Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial Exercise training in recently hospitalized heart failure patients enrolled in a disease management programme: design of the EJECTION-HF randomized controlled trial. Pharmacist Intervention to Improve Medication Adherence in Heart Failure Patient Engagement With a Mobile Web-Based Telemonitoring System for Heart Failure Self-Management: A Pilot Study Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design. Pilot study of remote telemonitoring in COPD. A cost-effectiveness analysis of retropubic midurethral sling versus transobturator midurethral sling for female stress urinary incontinence. Home Monitoring Should Be the Central Element in an Effective Program of Heart Failure Disease Management Design and methods of the Pro-B Type Natriuretic Peptide Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) Study. Patient-centred home-based management of heart failure Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol Home hospitalisation of exacerbated chronic obstructive pulmonary disease patients The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial Care Management for Low-Risk Patients with Heart Failure First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure – CardioBBEAT Remote monitoring of patients with biventricular defibrillators through the CareLink system improves clinical management of arrhythmias and heart failure episodes Telephone Care Management To Improve Cancer Screening among Low-Income Women
Abstract Aims Remote management of heart failure using implantable electronic devices ( REM-HF ) aim ed to assess the clinical and cost-effectiveness of remote monitoring ( RM ) of heart failure in patients with cardiac implanted electronic devices ( CIEDs ) . Methods and results Between 29 September 2011 and 31 March 2014 , we r and omly assigned 1650 patients with heart failure and a CIED to active RM or usual care ( UC ) . The active RM pathway included formalized remote follow-up protocol s , and UC was st and ard practice in nine recruiting centres in Engl and . The primary endpoint in the time to event analysis was the 1st event of death from any cause or unplanned hospitalization for cardiovascular reasons . Secondary endpoints included death from any cause , death from cardiovascular reasons , death from cardiovascular reasons and unplanned cardiovascular hospitalization , unplanned cardiovascular hospitalization , and unplanned hospitalization . REM-HF is registered with IS RCT N ( 96536028 ) . The mean age of the population was 70 years ( range 23–98 ) ; 86 % were male . Patients were followed for a median of 2.8 years ( range 0–4.3 years ) completing on 31 January 2016 . Patient adherence was high with a drop out of 4.3 % over the course of the study . The incidence of the primary endpoint did not differ significantly between active RM and UC groups , which occurred in 42.4 and 40.8 % of patients , respectively [ hazard ratio 1.01 ; 95 % confidence interval ( CI ) 0.87–1.18 ; P = 0.87 ] . There were no significant differences between the two groups with respect to any of the secondary endpoints or the time to the primary endpoint components . Conclusion Among patients with heart failure and a CIED , RM using weekly downloads and a formalized follow up approach does not improve outcomes Background Heart failure ( HF ) is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality . With an aging population , the cost associated with managing HF is expected to more than double from US $ 31 billion in 2012 to US $ 70 billion by 2030 . Readmission rates for HF patients are high—25 % are readmitted at 30 days and nearly 50 % at 6 months . Low medication adherence contributes to poor HF management and higher readmission rates .  Remote telehealth monitoring programs aim ed at improved medication management and adherence may improve HF management and reduce readmissions . Objective The primary goal of this r and omized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program .  We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department ( ED ) visits , increased medication adherence , and improved health-related quality of life ( HRQoL ) compared to usual care . Methods Participants were r and omized to usual care or use of the remote medication monitoring system for 90 days . Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants . Participants completed question naires at enrollment and closeout to gather data on medication adherence , health status , and HRQoL. Electronic medical records were review ed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period . Results Use of the medication monitoring system was associated with an 80 % reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care . Objective device data indicated high adherence rates ( 95%-99 % ) among intervention group participants despite finding no significant difference in self-reported adherence between study arms . The intervention group had poorer heart function and HRQoL at baseline , and HRQoL declined significantly in the intervention group compared to controls . Conclusions The MedSentry medication monitoring system is a promising technology that merits continued development and evaluation . The MedSentry medication monitoring system may be useful both as a st and alone system for patients with complex medication regimens or used to complement existing HF telemonitoring interventions . We found significant reductions in risk of all-cause hospitalization and the number of all-cause length of stay in the intervention group compared to controls . Although HRQoL deteriorated significantly in the intervention group , this may have been due to the poorer HF-functioning at baseline in the intervention group compared to controls . Telehealth medication adherence technologies , such as the MedSentry medication monitoring system , are a promising method to improve patient self-management , the quality of patient care , and reduce health care utilization and expenditure for patients with HF and other chronic diseases that require complex medication regimens . Trial Registration Clinical Trials.gov NCT01814696 ; https:// clinical trials.gov/ct2/show/ study /NCT01814696 ( Archived by WebCite ® at http://www.webcitation.org/6giqAVhno AIMS Only limited comparative data exist on the benefits of fluid monitoring ( FM ) combined with remote monitoring ( RM ) regarding morbidity and mortality of heart failure ( HF ) patients . This prospect i ve single-centre r and omized pilot study aim ed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality . METHODS AND RESULTS Patients with st and ard indication for implantable cardioverter defibrillator ( ICD ) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM , and were followed for 15 months . Subjects were r and omly allocated to RM including OptiVol and predefined management of alerts ( remote group ) , or st and ard in-office visits every 3 months ( control group ) . A total of 176 patients ( 77 % male ; 66 ± 12 years ; left ventricular ejection fraction ( LVEF ) 32 ± 11 % ; ischemic cardiomyopathy 50 % ; CRT device 50 % ; primary prevention 85 % ) were analysed . Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [ 0.62 - 2.44 ] ( P = 0.551 ) favouring the control group . In the remote group , 13 patients ( 15 % ) experienced ICD shocks vs. 10 patients ( 11 % ) in the control group ( P = 0.512 ) . The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm ( P = 0.994 ) . The Kaplan-Meier estimate of mortality after 1 year was 8.6 % ( eight deaths ) in the remote group vs. 4.6 % in the control group ( six deaths ; P = 0.502 ) . CONCLUSION In a single-centre r and omized pilot study of RM in combination with FM , no significant influence on HF-related hospitalizations , ICD shocks , or mortality was found Background We aim ed to establish the support needs of people with heart failure and their caregivers and develop an intervention to improve their health-related quality of life . Methods We used intervention mapping to guide the development of our intervention . We identified “ targets for change ” by synthesis ing research evidence and international guidelines and consulting with patients , caregivers and health service providers . We then used behaviour change theory , expert opinion and a taxonomy of behaviour change techniques , to identify barriers to and facilitators of change and to match intervention strategies to each target . A patient and public involvement group helped to identify patient and caregiver needs , refine the intervention objectives and strategies and deliver training to the intervention facilitators . A feasibility study ( IS RCT N25032672 ) involving 23 patients , 12 caregivers and seven trained facilitators at four sites assessed the feasibility and acceptability of the intervention and quality of delivery and generated ideas to help refine the intervention . Results The Rehabilitation Enablement in Chronic Heart Failure ( REACH-HF ) intervention is a comprehensive self-care support programme comprising the “ Heart Failure Manual ” , a choice of two exercise programmes for patients , a “ Family and Friends Re source ” for caregivers , a “ Progress Tracker ” tool and a facilitator training course . The main targets for change are engaging in exercise training , monitoring for symptom deterioration , managing stress and anxiety , managing medications and underst and ing heart failure . Secondary targets include managing low mood and smoking cessation . The intervention is facilitated by trained healthcare professionals with specialist cardiac experience over 12 weeks , via home and telephone contacts . The feasibility study found high levels of satisfaction and engagement with the intervention from facilitators , patients and caregivers . Intervention fidelity analysis and stakeholder feedback suggested that there was room for improvement in several areas , especially in terms of addressing caregivers ’ needs . The REACH-HF material s were revised accordingly . Conclusions We have developed a comprehensive , evidence -informed , theoretically driven self-care and rehabilitation intervention that is grounded in the needs of patients and caregivers . A r and omised controlled trial is underway to assess the effectiveness and cost-effectiveness of the REACH-HF intervention in people with heart failure and their caregivers IMPORTANCE It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure ( HF ) after hospitalization . OBJECTIVE To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF . DESIGN , SETTING , AND PARTICIPANTS We r and omized 1437 patients hospitalized for HF between October 12 , 2011 , and September 30 , 2013 , to the intervention arm ( 715 patients ) or to the usual care arm ( 722 patients ) of the Better Effectiveness After Transition-Heart Failure ( BEAT-HF ) study and observed them for 180 days . The date s of our study analysis were March 30 , 2014 , to October 1 , 2015 . The setting was 6 academic medical centers in California . Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF . INTERVENTIONS The intervention combined health coaching telephone calls and telemonitoring . Telemonitoring used electronic equipment that collected daily information about blood pressure , heart rate , symptoms , and weight . Central ized registered nurses conducted telemonitoring review s , protocol ized actions , and telephone calls . MAIN OUTCOMES AND MEASURES The primary outcome was readmission for any cause within 180 days after discharge . Secondary outcomes were all-cause readmission within 30 days , all-cause mortality at 30 and 180 days , and quality of life at 30 and 180 days . RESULTS Among 1437 participants , the median age was 73 years . Overall , 46.2 % ( 664 of 1437 ) were female , and 22.0 % ( 316 of 1437 ) were African American . The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge , which occurred in 50.8 % ( 363 of 715 ) and 49.2 % ( 355 of 722 ) of patients , respectively ( adjusted hazard ratio , 1.03 ; 95 % CI , 0.88 - 1.20 ; P = .74 ) . In secondary analyses , there were no significant differences in 30-day readmission or 180-day mortality , but there was a significant difference in 180-day quality of life between the intervention and usual care groups . No adverse events were reported . CONCLUSIONS AND RELEVANCE Among patients hospitalized for HF , combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01360203 Background Heart failure is a prevalent health problem associated with costly hospital readmissions . Transitional care programs have been shown to reduce readmissions but are costly to implement . Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed . The objective of this r and omized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight , blood pressure , heart rate , and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure . Methods / Design A multi-center , r and omized controlled trial is being conducted at six academic health systems in California . A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure . Patients in the intervention group will receive intensive patient education using the ‘ teach-back ’ method and receive instruction in using the telemonitoring equipment . Following hospital discharge , they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a central ized call center . The nurses also will call patients and patients ’ physicians in response to alerts generated by the telemonitoring system , based on predetermined parameters . The primary outcome is readmission for any cause within 180 days . Secondary outcomes include 30-day readmission , mortality , hospital days , emergency department ( ED ) visits , hospital cost , and health-related quality of life . Discussion BEAT-HF is one of the largest r and omized controlled trials of telemonitoring in patients with heart failure , and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring . The study population also includes patients with a wide range of demographic and socioeconomic characteristics . Once completed , the study will be a rich re source of information on how best to use remote technology in the care management of patients with chronic heart failure . Trial registration Clinical Trials.gov # NCT01360203 Remote monitoring ( RM ) of homebound heart failure ( HF ) patients has previously been shown to reduce hospital admissions . We conducted a pilot trial of ambulatory , non-homebound patients recently hospitalized for HF to determine whether RM could be successfully implemented in the ambulatory setting . Eligible patients from Massachusetts General Hospital ( n = 150 ) were r and omized to a control group ( n = 68 ) or to a group that was offered RM ( n = 82 ) . The participants transmitted vital signs data to a nurse who coordinated care with the physician over the course of the 6-month study . Participants in the RM program had a lower all-cause per person readmission rate ( mean = 0.64 , SD ± 0.87 ) compared to the usual care group ( mean = 0.73 , SD ± 1.51 ; P-value = .75 ) although the difference was not statistically significant . HF-related readmission rate was similarly reduced in participants . This pilot study demonstrates that RM can be successfully implemented in non-homebound HF patients and may reduce readmission rates AIMS Remote patient management ( telemonitoring ) may help to detect early signs of cardiac decompensation , allowing optimization of and adherence to treatments in chronic heart failure ( CHF ) . Two meta-analyses have suggested that telemedicine in CHF can reduce mortality by 30 - 35 % . The aim of the TIM-HF study was to investigate the impact of telemedical management on mortality in ambulatory CHF patients . Methods CHF patients [ New York Heart Association ( NYHA ) II/III , left ventricular ejection fraction (LVEF)≤35 % ] with a history of cardiac decompensation with hospitalization in the past or therapy with intravenous diuretics in the prior 24 months ( no decompensation required if LVEF≤25 % ) were r and omized 1:1 to an intervention group of daily remote device monitoring ( electrocardiogram , blood pressure , body weight ) coupled with medical telephone support or to usual care led by the patients ' local physician . In the intervention group , 24/7 physician-led medical support was provided by two central telemedical centres . A clinical event committee blinded to treatment allocation assessed cause of death and reason for hospitalization . The primary endpoint was total mortality . The first secondary endpoint was a composite of cardiovascular mortality or hospitalization due to heart failure . Other secondary endpoints included cardiovascular mortality , all-cause and cause-specific hospitalizations ( all time to first event ) as well as days lost due to heart failure hospitalization or cardiovascular death ( in % of follow-up time ) , and changes in quality of life and NYHA class . Overall , 710 CHF patients were recruited . The mean follow-up was 21.5±7.2 months , with a minimum of 12 months . Perspective The study will provide important prospect i ve outcome data on the impact of telemedical management in patients with CHF BACKGROUND The Home or Hospital in Heart Failure Study ( HHH ) is a European Community funded trial ( QLGA-CT-2001 - 02424 ) which compares usual care of heart failure ( HF ) with three home-based interventions in a multicenter , multicountry ( Italy , Pol and and UK ) , r and omized controlled clinical trial . Home telemonitoring ( HT ) of clinical parameters represents a potential alternative ( or addition ) to traditional home care models . Nocturnal respiratory disorders ( periodic breathing , sleep apnea ) are very common in HF , and are associated with increased morbidity and mortality . We developed an integrated HT system for monitoring of both vital signs and respiration . All measurements were patient-managed . This paper describes the architecture of this system , and assesses its feasibility . METHODS AND RESULTS 461 clinical ly stable patients were r and omized first to usual vs home-monitored care ; the latter were further r and omized to 3 strategies . Over a 12-month follow-up 2 of these 3 groups ( 195 patients , age : 60+/-11 years , NYHA class II-III : 97 % , LVEF 28+/-7 % ) underwent self-administered home monitoring of vital signs ( weekly--12 parameters using an interactive voice response system ) and respiration ( monthly--24-hour recording ) . Data were transmitted over conventional telephone lines ; 81 % of actually practicable vital signs measurements were completed by the patients ( range : 75 % (PL)-93 % ( UK ) ) , as well as 92 % of practicable respiratory recordings ( range : 85 % (PL)-99 % ( UK ) ) . 87 % of nighttime recordings were eligible for the study ( good quality signals for > or = 2.5 h ) . CONCLUSIONS This study , the largest so far , demonstrates that self-managed home telemonitoring of both vital signs and respiration is feasible in HF patients , with surprisingly high compliance . We found an excellent rate of acceptable nocturnal respiratory recordings , which are those with the greatest clinical relevance Acute heart failure syndromes ( AHFS ) represent the most common discharge diagnoses in adults over age 65 and translate into dramatically increased heart failure – associated morbidity and mortality . Conventional approaches to the early detection of pulmonary and systemic congestion have been shown to be of limited sensitivity . Despite their proven efficacy , disease management and structured telephone support programs have failed to achieve widespread use in part due to their re source intensiveness and reliance upon motivated patients . While once thought to hold great promise , results from recent prospect i ve studies on telemonitoring strategies have proven disappointing . Implantable devices with their capacity to monitor electrophysiologic and hemodynamic parameters over long periods of time and with minimal reliance on patient participation may provide solutions to some of these problems . Conventional electrophysiologic parameters and intrathoracic impedance data are currently available in the growing population of heart failure patients with equipped devices . A variety of implantable hemodynamic monitors are currently under investigation . How best to integrate these devices into a systematic approach to the management of patients before , during , and after AHFS  is yet to be established We studied 138 patients admitted for heart failure ( HF ) . Patients were allocated one of three treatment strategies . Group 1 ( G1 , n = 50 ) were given usual care for HF , Group 2 ( G2 , n = 56 ) received a multi-disciplinary team approach , while Group 3 ( G3 , n = 32 ) had home telephone self-monitoring . Telemonitoring was based on the answers to three simple queries about bodyweight change , dyspnoea and general health . The system stratified the HF severity of each patient once a week , and recommended a prompt medical appointment or simple follow-up . Over a 12-month follow-up period , there were 43 adverse events ( cardiovascular deaths and rehospitalizations for HF : G1 = 22 , G2 = 14 , G3 = 7 ) . There was no difference between G2 and G3 ( P = 0.78 ) but there was significant disadvantage with usual care ( P = 0.02 vs. G2 and P = 0.04 vs. G3 ) . Time to re-admission for HF increased in G2 and G3 compared to G1 ( 188 and 198 days vs. 95 days , P = 0.03 and P = 0.02 respectively ) . Automated home telephone self-monitoring reduced rehospitalization in patients with advanced HF Patient self-management is a critical determinant of heart failure ( HF ) outcomes , yet patients with HF are often frail and socially isolated , factors that may limit their ability to manage self-care and access clinic-based services . Mobilizing peer support among HF patients is a promising strategy to improve self-management support . In this pilot , the authors evaluated the feasibility and acceptability of an interactive voice response (IVR)-based platform to facilitate telephone peer support among older adults with HF . Participants completed a baseline survey , were offered a 3-hour training session in peer communication skills , and were paired with another patient who had HF . Participants were asked to contact their partner weekly using a toll-free IVR phone system that protected their anonymity and provided automated reminders if contacts were not made . Times and duration of participants ' telephone contacts were monitored and recorded . After the 7-week intervention , participants completed surveys and brief face-to-face interviews . The authors found high levels of use and satisfaction and improvements in depressive symptoms among the 20 pilot study participants . An IVR peer-support intervention is feasible , is acceptable to patients , and may have positive effects on patients '  HF social support and health outcomes , in conjunction with structured health system support , that warrant more rigorous evaluation in a r and omized trial BACKGROUND Prior studies suggest that disease management programs may be effective in improving clinical and economic outcomes in patients with heart failure . Whether these types of programs can lower health care cost and be adapted to the primary care setting is unknown . This study was design ed to assess the impact of a home-based disease management program , the Alere DayLink HF Monitoring System ( HFMS ) , on the clinical and economic outcomes of Medicare beneficiaries recently hospitalized for heart failure who received the care from a community-based primary care practitioner . METHODS AND RESULTS The Heart Failure Home Care trial was a multicenter , r and omized , controlled trial of sophisticated , monitoring of heart failure patients with an interactive program versus st and ard heart failure care with enhanced patient education and follow-up ( SC ) in Medicare-eligible patients . The study endpoints included cardiovascular death or rehospitalization for heart failure , length of hospital stay , total patient cost , and cost to Medicare at 6 months of enrollment . A total of 315 patients age ≥ 65 years old were r and omized : 160 to the HFMS and 155 to SC . There were no significant statistical differences between the groups in regards to 6-month cardiac mortality , rehospitalizations for heart failure , or length of hospital stay . Of those , 304 patients had their Medicare data available . The information from the Medicare cl aims data was used to determine the cost . Information from the trial was used to determine costs of out-patient drugs and the interventions . The 6-month mean Medicare costs were estimated to be $ 17,837 and $ 13,886 for the HFMS and the SC groups , respectively . We found that overall medical costs of medicare patients were significantly higher for patients who were r and omized to the HFMS arm than they were for the patients r and omized to the SC arm . CONCLUSIONS Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program and less costly in patients who are elderly and receive the care from a community-based primary care practitioner Abstract Introduction Congestive heart failure ( CHF ) , which typically affects older people , is characterized by high short- and mid-term mortality rates . However , despite accumulating evidence showing that administration of β-blockers ( β-adrenoceptor antagonists ) can improve the clinical status of CHF patients , use of these agents in adequate dosages in this setting is not routine . One reason for this appears to be a concern about a possible risk of bradyarrhythmia associated with use of β-blockers . Telecardiology has recently been investigated as a means of constantly monitoring the heart rate of CHF patients in their homes . Its use may allay concerns about the risk of bradyarrhythmia and facilitate a more widespread use of β-blockers in this context . Objectives The primary objectives of this study were to assess the impact of telemonitoring on patients ’ adherence to prescribed therapeutic regimens , particularly β-blockers , and to explore whether use of home telemonitoring reduces mortality and rate of re-admission to hospital in elderly CHF patients compared with normal specialized CHF team care . Methods A total of 57 patients with CHF ( 31 New York Heart Association [ NYHA ] class II , 23 NYHA class III and 3 NYHA class IV ) , with a mean ±SD age of 78.2±7.3 years , were r and omized to a control group who received st and ard care  , based on routinely scheduled clinic visits , from a team specialized in CHF patient management , or to a home telemonitoring group ( TM group )  , managed by the same specialized CHF team . Patients were followed up over 12 months . Results Compared with the control group , the TM group had a significant increase in the use of β-blockers , HMG-CoA reductase inhibitors ( statins ) and aldosterone receptor antagonists . A reduction in nitrate administration compared with baseline was also seen in the TM group . The 12-month occurrence of the primary combined endpoint of mortality and hospital re-admission for CHF was significantly lower in the TM group than in the control group ( p < 0.01 ) . Conclusions This study showed that a home-care model including telemonitoring of relevant clinical parameters may provide useful support in the management of patients with CHF . Home telemonitoring in CHF patients was associated with increased use of β-blockers at appropriate doses , suggesting that this strategy reassured physicians regarding the safety of careful use of these agents in this setting . However , larger studies are required to confirm these findings . Our findings indicate that there is a need to investigate relevant parameters in CHF patients at the point of care ( i.e. in patients ’ daily lives ) , which can in turn optimize β-blocker and other drug therapy Background Telemonitoring technology offers one of the most promising alternatives for the provision of health care services at the patient 's home . The primary aim of this study is to evaluate the impact of a primary care-based telemonitoring intervention on the frequency of hospital admissions . Methods / design A primary care-based r and omised controlled trial will be carried out to assess the impact of a telemonitoring intervention aim ed at home care patients with heart failure ( HF ) and /or chronic lung disease ( CLD ) . The results will be compared with those obtained with st and ard health care practice . The duration of the study will be of one year . Sixty patients will be recruited for the study . In-home patients , diagnosed with HF and /or CLD , aged 14 or above and with two or more hospital admissions in the previous year will be eligible . For the intervention group , telemonitoring will consist of daily patient self- measurements of respiratory-rate , heart-rate , blood pressure , oxygen saturation , weight and body temperature . Additionally , the patients will complete a qualitative symptom question naire daily using the telemonitoring system . Routine telephone contacts will be conducted every fortnight and additional telephone contacts will be carried out if the data received at the primary care centre are out of the established limits . The control group will receive usual care . The primary outcome measure is the number of hospital admissions due to any cause that occurred in a period of 12 months post-r and omisation . The secondary outcome measures are : duration of hospital stay , hospital admissions due to HF or CLD , mortality rate , use of health care re sources , quality of life , cost-effectiveness , compliance and patient and health care professional satisfaction with the new technology . Discussion The results of this study will shed some light on the effects of telemonitoring for the follow-up and management of chronic patients from a primary care setting . The study may contribute to enhance the underst and ing of alternative modes of health care provision for medically unstable elderly patients , who bear a high degree of physical and functional deterioration . Trial Registration IS RCT N : IS RCT Background Frequent rehospitalisations and poorer survival chances in heart failure ( HF ) patients may partly be explained by poor medication adherence . There are multiple medication-related reasons for suboptimal adherence , but psychological reasons may also be important . A novel TELEmonitoring device may improve MEDication adherence in HF patients ( TELEMED-HF ) . TELEMED-HF is a r and omized , controlled clinical intervention trial design ed to examine ( 1 ) the efficacy and cost-efficiency of an electronic medication adherence support system in improving and monitoring HF patients ' medication adherence ; ( 2 ) the effect of medication adherence on hospitalizations and health care consumption ; as well as on ( 3 ) clinical characteristics , and Quality of Life ( QoL ) ; and ( 4 ) clinical , sociodemographic , and psychological determinants of medication adherence . Methods / Design Consecutive patients with chronic , systolic HF presenting to the outpatient clinic of the TweeSteden Hospital , The Netherl and s , will be approached for study participation and r and omly assigned ( 1:1 ) following blocked r and omization procedures to the intervention ( n = 200 ) or usual care arm ( n = 200 ) . Patients in the intervention arm use the medication support device for six months in addition to usual care . Post-intervention , patients return to usual care only and all patients participate in four follow-up occasions over 12 months . Primary endpoints comprise objective and subjective medication adherence , healthcare consumption , number of hospitalizations , and cost-effectiveness . Secondary endpoints include disease severity , physical functioning , and QoL. Discussion The TELEMED-HF study will provide us a comprehensive underst and ing of medication adherence in HF patients , and will show whether telemonitoring is effective and cost-efficient in improving adherence and preventing hospitalization in HF patients .Trial registration numberNCT01347528 BACKGROUND Heart failure ( HF ) is a major public health problem . Case management by nurses using telephone follow-up has been suggested as a convenient and effective mechanism to promote the self-management of HF . Similarly , a patient empowerment approach to the management of chronic disease has been suggested as one that may nurture self-management in individuals with chronic illness . OBJECTIVE The purpose of this study was to examine the effects of a telephone-delivered empowerment intervention ( EI ) on clinical ly and theoretically relevant outcomes in patients with HF , including purpose ful participation in goal attainment , self-management of HF , and perception of functional health . The EI was guided by Rogers ' Science of Unitary Human Beings person-environment process . METHODS A convenience sample of men and women aged 21 years and older with a clinical diagnosis of HF was obtained from a metropolitan hospital located in the southwestern United States . The participants were r and omly assigned to the control group ( n = 45 ) or EI group ( n = 45 ) . All participants received st and ardized HF patient education ; the intervention group also received an EI delivered through telephone follow-up calls from a registered nurse . Repeated- measures analysis of variance was used to evaluate intervention effects . RESULTS The telephone-delivered EI  facilitated self-management of HF through self-care activities in EI group members . CONCLUSION The knowledge gained from this study provides a beginning underst and ing of strategies to enhance health care providers ' ability to facilitate self-management of HF among patients diagnosed with HF Objective Heart failure ( HF ) is a major health problem result ing in a high financial burden for the healthcare system . Many previous HF management programmes reduced adverse clinical outcomes and costs , but they usually involved several professional figures as well as huge investments , requiring re sources and budgets not often available in our healthcare system . We evaluated the effects of our HF management programme , which included patient education and regular outpatient contact with the HF team , on re-hospitalisation and death , optimising the few re sources already available at our hospital . Methods Two hundred consecutive patients admitted to the internal medicine department with a diagnosis of HF were r and omised to the intervention group ( nurse-led education programme , facilitated telephone communication and follow-up visits with an internist at 15 days , 1 and 6 months ) or to the usual care group ( follow-up by their primary care physician ) . The primary endpoints were all-cause readmissions and all-cause deaths during the 6-month post-discharge period . Results There were 81 all-cause hospital readmissions in the intervention group and 82 in the control group ( P = NS ) . Fourteen patients ( 14 % ) in the intervention group and eight patients ( 8 % ) in the control group died during the study period ( P = NS ) . Unplanned outpatient visits were less frequent in the intervention group than in the control group ( 39 [ 28 % ] versus 99 [ 72 % ] , P < 0.001 ) . Conclusions The present low-cost HF management programme reduced unplanned outpatient visits but proved ineffective in reducing subsequent readmissions and in improving clinical status . More intense follow-up monitoring and more re sources are needed to achieve better results Background Patients with recent stroke or TIA are at high risk for new vascular events . Several evidence based strategies in secondary prevention of stroke are available but frequently underused . Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospect i ve controlled trials so far . INSPiRE-TMS is a prospect i ve , multi-center , r and omized open intervention trial for intensified secondary prevention after minor stroke and TIA . Methods / design Patients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay . Patients are r and omised in a 1:1 ratio to intervention ( support program ) and control ( usual care ) arms . Inclusion of 2.082 patients is planned . The support program includes cardiovascular risk factor measurement and feedback , monitoring of medication adherence , coaching in lifestyle modifications , and active involvement of relatives . St and ardized motivational interviewing is used to assess and enhance patients ’ motivation . Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infa rct ion or vascular death . Recruitment time is planned for 3.5 years , follow up time is at least 2 years for every patient result ing in a total study time of 5 years ( first patient in to last patient out ) . Discussion Given the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention , the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time . The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care . A cost-effectiveness evaluation will be performed . Trial registration clinical trials.gov : INTRODUCTION AND OBJECTIVES Multidisciplinary strategies for the management of heart failure ( HF ) improve outcomes . We aim ed to evaluate the effectiveness of noninvasive home telemonitoring in ambulatory patients with HF already included in a structured multidisciplinary HF program . METHODS Prospect i ve intervention study with before/after comparison design of an interactive telemedicine platform in HF patients , r and omized 1:1 into two groups : A ) Motiva System with educational videos , motivational messages , and question naires , and B ) Motiva System + self monitoring of blood pressure , heart rate , and weight . Hospitalizations were compared over 12 months prior to and post study inclusion . Quality of life was evaluated using the generic EuroQoL visual analogue scale and the specific question naire Minnesota Living With Heart Failure Question naire . RESULTS There were 92 patients included ( 71 % male ; 66.3 ± 11.5 years ; 71 % ischemic aetiology ) . During real-time telemonitoring over 11.8 months ( interquartile range 8.6 - 12 ) , 14,730 question naires were administered with 89 % median response rate . Hospitalizations for HF decreased by 67.8 % ( P = .010 ) and for other cardiac causes by 57.6 % ( P = .028 ) . The number of days in hospital for HF decreased by 73.3 % ( P = .036 ) , without statistically significant differences between groups , and for other cardiac causes by 82.9 % ( P = .008 ) . The perception of quality of life improved significantly both for the generic scale ( P < .001 ) and for the HF specific question naire ( P=.005 ) . CONCLUSIONS HF patients who used an interactive telehealth system with motivational support tools at home spent less time in hospital and felt their quality of life had significantly improved . No significant differences were observed between groups BACKGROUND Nursing approaches to manage patients with heart failure ( HF ) showed benefits in reducing the morbidity and mortality . However , combining intra-hospital education with telephone contact after hospital discharge has been little explored . OBJECTIVE To compare two nursing intervention groups among patients hospitalized due to decompensated HF : the intervention group ( IG ) received educational nursing intervention during hospitalization followed by telephone monitoring after discharge and the  control group  ( CG ) received in-hospital intervention only . Outcomes were levels of HF and self-care knowledge , the frequency of visits to the emergency room , rehospitalizations and deaths in a three-month period . METHODS R and omized clinical trial . We studied adult HF patients with left ventricle ejection fraction ( LVEF ) < 45 % who could be contacted by telephone after discharge .  HF awareness was evaluated through a st and ardized question naire that also included questions regarding self-care knowledge , which was answered during the hospitalization period and three months later . For patients in the IG group contacts were made using phone calls and final interviews were conducted in both groups at end of the study . RESULTS Forty-eight patients were assigned to the IG and 63 to the CG . Mean age ( 63 ± 13 years ) and L ( around 29 % ) were similar in the two groups . Scores for HF and self-care knowledge were similar at baseline . Three months later , both groups showed significantly improved HF awareness and self-care knowledge scores ( P < 0.001 ) . Other outcomes were similar . CONCLUSION An in-hospital educational nursing intervention benefitted all HF patients in underst and ing their disease , regardless of telephone contact after discharge Patients admitted with heart failure have disproportionately high readmission rates , most recently ranging from 17.5 % to 30.3 % nationally.1 The Affordable Care Act penalizes hospitals with higher than average readmission rates after admissions for heart failure . However , clinicians remain uncertain , which strategies are associated with reducing readmissions in this population .2 Experts have proposed that the creation and transmission of a high- quality discharge summary to outpatient clinicians may improve the transition from hospital to home . Discharge summaries may facilitate safer transitions in care by informing outpatient clinicians about the course of hospitalization , identifying pending studies requiring follow-up , suggesting further follow-up testing , and clarifying changes in medications and treatments after discharge . Nonetheless , despite widespread enthusiasm for improving the quality of discharge summaries , there have been few studies of the effectiveness of discharge summaries in helping to avoid readmissions , and those few have found no association of timeliness,3,4 transmission,5,6 or content5 with readmission . To determine the association of discharge quality and readmission in a large national sample , we examined discharge summaries of patients enrolled in the Telemonitoring to Improve Heart Failure Outcomes ( Tele-HF ) r and omized controlled trial . # # # Study Cohort and Setting The  Tele-HF study included patients living at home and hospitalized for heart failure in the previous 30 days.7 Patients in Tele-HF were recruited from 33 cardiology practice s in 21 states and the District of Columbia . We obtained discharge summaries for the index hospitalization . Wherever possible , we obtained Heart failure has been named “ the growing epidemic . ” Over the last decade , the annual number of heart failure hospitalizations has almost doubled with approximately 50 % of patients being rehospitalized within 6 months of discharge [ 1 ] . The complex array of physiologic , psychological , social , and health care delivery issues makes it a challenging chronic disease to manage . Underst and ing the epidemiology and pathophysiology of the syndrome , identifying the predictors and their strength of association with outcomes , and using the available diagnostic modalities cost-effectively are essential in order to devise effective prevention interventions and implement novel therapeutic approaches to curb this epidemic . In this special issue , we have invited a few papers that address such issues and explain why despite the emergence of novel therapeutic approaches , that promise life prolongation and hospital length reduction , this patient population will still be needing rehospitalization and will often have a poor prognosis . This special issue is the extension of an effort that was initiated in 2011 with the first heart-failure-focused issue [ 2 ] . In the pathophysiology section , S. M. R. Kazemi-Bajestani et al. describe the opportunities and challenges of targeting the angiotensin converting enzyme 2 (ACE2)/Ang II/Ang1–7 and apelin/APJ pathways as novel therapeutic modalities in heart failure [ 3 ] . ACE2 and the apelin/APJ are two important peptide systems which exert diverse effects on the cardiovascular system . Dysregulation of such systems may be involved in the predisposition to cardiovascular diseases whereas enhancing their action may have important therapeutic effects . In the same section , D. Lindner et al. provide a comprehensive review on the protective function of signal transducer and activator of transcription 3 ( STAT3 ) in CVB3-induced myocarditis [ 4 ] . The transcription factor ( STAT3 ) is an important mediator of the inflammatory process , and in this original research the investigators examine the role of STAT3 in viral myocarditis and its possible role in the development to dilated cardiomyopathy . Considering the high mortality rate and the availability of life-saving therapies like transplantation and left ventricular assist devices , accurate prognosis determination in HF is clinical ly important . Taking into account the mediocre performance of current established prediction models , such as the Seattle Heart Failure Model [ 5–7 ] , the work by H. Fukuta et al. [ 8 ] on the prognostic value of left ventricular diastolic dysfunction in patients undergoing cardiac catheterization for coronary artery disease sheds light on this extremely important topic . A shared underst and ing of medical conditions between patients and their health care providers has been shown to improve self-care and outcomes [ 9 ] . In the comorbidity section , we demonstrate how certain comorbid conditions may affect patients ' decision-making capacity and interfere with their ability to comply with treatment requirements , recognize and self-manage disease worsening symptoms . Among others , cognitive impairment is increasingly recognized as a common adverse consequence of HF , whereby phenomena such as microembolism , chronic or intermittent cerebral hypoperfusion , and /or impaired cerebral vessel reactivity may lead to cerebral hypoxia and ischemic brain damage . Cognitive decline in HF is characterized by deficits in one or more cognition domains , including attention , memory , executive function , and psychomotor speed . E. Dardiotis et al. [ 10 ] , in a comprehensive review , underscore the importance for healthcare professionals to become familiar with assessment of cognitive performance using st and ardized screening instruments in their routine evaluations of HF patients . Another comorbidity gaining increasing attention in HF patients is depression . There are several pathophysiological mechanisms as well as behavioral processes linking depression and HF . Equally important is screening for depression and there are several valid and reliable screening tools to identify patients at greater risk . Consultation should be provided by a multidisciplinary team , consisting of cardiologists , psychiatrists , and hospital or community nurses so as to carefully plan , execute , and evaluate medical intervention and implement lifestyle changes . D. Mastrogiannis et al. [ 11 ] systematic ally review the existing knowledge regarding current definitions , prognostic implication s , pathophysiological mechanisms , and current and future treatment options in patients with depression and HF . Evidence from the literature supports the possibility of a pathophysiological relationship between cognitive impairment , depression , and HF . Yet , very few studies have sought to investigate this relationship . The paper by Z. N. Sohani and Z. Samaan review s current literature on the association between depression and cognitive impairment  in persons with HF and explores possible mechanisms explaining this complex triad [ 12 ] . Heart failure through neurohumoral activation induces alterations of cardiac metabolism , such as insulin resistance , and promotes increased utilization of noncarbohydrate substrates for energy production [ 13 , 14 ] . Fasting blood ketone bodies as well as fat oxidation have been shown to be increased in this patient population . The result is depletion of myocardial ATP , phosphocreatine , and creatine kinase , leading to decreased efficiency of mechanical work . A direct approach to manipulate cardiac energy metabolism consists in modifying substrate utilization by the failing heart . Trimetazidine , perhexiline , and ranolazine directly inhibit fatty acid oxidation and have been used to increase the ischemic threshold in patients with effort angina . Current research is supporting the concept that shifting the energy substrate preference away from fatty acid metabolism and toward glucose metabolism could be an effective adjunctive treatment in patients with HF . These agents have been shown to improve both glucose metabolism and left ventricular function in diabetic patients with left ventricular dysfunction . In the pharmacotherapy section , we provide a systematic review , in which N. Signoretta et al. [ 15 ] discuss the beneficial therapeutic effects of modulation of cardiac metabolic substrates utilization in patients with HF . In the advanced heart failure section , we provide a thorough review on the current status of mechanical circulatory support in patients with advanced HF . Management of the advanced HF patients with the numerous comorbidities [ 16 , 17 ] requires a significant amount of health care re sources and is becoming a major public health problem . As therapeutical strategies for HF have been refined , the number of patients suffering from the end-stage disease has exp and ed dramatically . Although heart transplantation still represents the gold st and ard therapeutical approach , the shortage of donors universally has made the implantation of mechanical circulatory support devices a well-established management for this disease . The systematic review by K. Spiliopoulos et al. [ 18 ] , outlines the current status of mechanical circulatory support in this patient population . In the chronic follow-up section , we deal with telemonitoring , a novel diagnostic modality that has been suggested to be beneficial for HF patients , targeting optimization of their chronic followup . Telemonitoring is viewed as a means of recording physiological data ( such as body weight , heart rate , arterial blood pressure electrocardiogram recordings , and other data ) by portable devices and transmitting these data remotely ( via a telephone line , a mobile phone , or a computer ) to a server where they can be stored , review ed , and analyzed by the research team . In a systematic review of all r and omized clinical trials evaluating telemonitoring in chronic HF , G. Giamouzis et al. [ 19 ] assess whether telemonitoring provides any substantial benefit in this patient population . We hope that the readers of the journal will find the topics as interesting and important as we did . Gregory Giamouzis George Giannakoulas Javed Butler John A. Elefteriades Carsten Tschope Filippos Background : Heart failure ( HF ) has clinical ly significant psychological and physical consequences for older persons , and hospitalization for HF is frequent and costly to the Medicare program . As HF is the most common primary Medicare home care diagnosis , there is a critical need to develop home care services that improve heath-related outcomes for this population . The primary aim of this pilot study was to develop , implement , and test the initial feasibility and potential efficacy of the Home-Care Education , Assessment , Remote-Monitoring , and Therapeutic Activities ( HEART ) trial , a nurse-directed multicomponent home care intervention . Observed outcomes were quality of life ( QOL ) , depressive symptoms , and 90-day hospitalization . Methods : Twenty-four patients with a primary diagnosis of HF were assigned to the intervention ( n = 12 ) or control group ( n = 12 ) according to geographical location in a large multibranch Medicare-certified home health agency . Intervention group patients received 8 structured nurse education visits using evidence -based protocol s design ed in previous trials to teach HF self-management and to prevent/reduce depression , as well as a telemonitoring system . Control group patients received usual care and telemonitoring .  Quality of life was assessed using the Minnesota Living With Heart Failure question naire . Depressive symptoms were assed using the Patient Health Question naire 9 at baseline and 90-day study end point . Results : Study protocol s and instrumentation were found to be feasible and effective . Examination of enrollment data led to a reevaluation of eligibility criteria . Patients participating in the HEART intervention demonstrated significantly improved QOL ( F = 8.99 , P = .007 ) and significantly reduced depressive symptoms ( F = 35.10 , P = .001 ) in comparison to control group patients at the study end point . There was a trend toward lower hospital readmission rates in the intervention group ( 16 % vs 25 % ) , but this was not statistically significant . Conclusion : This pilot study suggests that a full-scale trial of the HEART intervention is feasible BACKGROUND Outcomes related to chronic heart failure ( HF ) remain relatively poor , despite advances in pharmacological therapy and medical and nursing care . Experts agree that outpatient care may be among the factors that affect HF outcomes . We hypothesized that the method by which outpatient care is delivered may affect outcomes in this patient population . METHODS A prospect i ve , r and omized design was used to compare HF outcomes from 216 patients r and omized to 1 of 2 home health care delivery methods for 3 months after discharge . Care was delivered by the home nurse visit ( HNV ) or the nurse telemanagement ( NTM ) method . In the latter , patients used transtelephonic home monitoring devices to measure their weight , blood pressure , heart rate , and oxygen saturation . These data were transmitted daily to a secure Internet site . An advanced- practice nurse worked collaboratively with a cardiologist and subsequently treated patients via the telephone . Both delivery methods used the same HF-specific clinical guidelines to direct care . Outcomes include HF readmissions and length of stay , anxiety , depression , self-efficacy , and quality of life . Data were primarily tested using a 2-group analysis of variance ( ANOVA ) . We used a repeated- measures ANOVA to conduct preintervention-postintervention analyses . RESULTS After 3 months , patients in the  NTM group ( n = 108 ; mean + /- SD age , 62.9 + /- 13.2 years ; 83 % African American ; 64 % female ) had fewer HF readmissions ( 13 vs 24 ; P</=.001 ) with shorter lengths of stay ( 49.5 vs 105.0 days ; P</=.001 ) compared with the HNV group ( n = 108 ; mean + /- SD age , 63.2 + /- 12.6 years ; 89 % African American ; 62 % female ) . Hospitalization charges at 3 months were less in the NTM group compared with the HNV group ( $ 65 023 vs $ 177 365 ; P</=.02 ) . At 6 and 12 months , cumulative readmission charges in the NTM group were also less ( $ 223 638 vs $ 500 343 [ P<.03 ] and $ 541 378 vs $ 677 710 [ P</=.16 ] , respectively ) compared with the HNV group . Quality of life was significantly improved for both groups when we compared postintervention and preintervention scores . CONCLUSION The adaptation of state-of-the-art computerized technology to closely monitor patients with HF with advanced- practice nurse care under the guidance of a cardiologist significantly improves HF management while reducing the cost of care Background Heart failure patients with implantable defibrillators place a significant burden on health care systems . Remote monitoring allows assessment of device function and heart failure parameters , and may represent a safe , effective , and cost-saving method compared to conventional in-office follow-up . Objective We hypothesized that remote device monitoring represents a cost-effective approach . This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators ( EVOLVO ) study , a multicenter clinical trial aim ed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators . Methods Two hundred patients implanted with a wireless transmission – enabled implantable defibrillator were r and omized to receive either remote monitoring or the conventional method of in-person evaluations . Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups . The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient . A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality -adjusted life year ( QALY ) gained . Results Overall , remote monitoring did not show significant annual cost savings for the health care system ( € 1962.78 versus € 2130.01 ; P=.80 ) . There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the st and ard arm ( € 291.36 versus € 381.34 ; P=.01 ) . Cost-utility analysis was performed for 180 patients for whom QALYs were available . The patients in the remote arm gained 0.065 QALYs more than those in the st and ard arm over 16 months , with a cost savings of € 888.10 per patient . Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution . Conclusions Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations . Trial Registration Clinical Trials.gov NCT00873899 ; http:// clinical trials.gov/show/NCT00873899 ( Archived by WebCite at http://www.webcitation.org/6H0BOA29f ) Background Primary health professionals are well positioned to support the delivery of patient self-management in an evidence -based , structured capacity . A need exists to better underst and the active components required for effective self-management support , how these might be delivered within primary care , and the training and system changes that would subsequently be needed . Objectives ( 1 ) To examine self-management support interventions in primary care on health outcomes for a wide range of diseases compared to usual st and ard of care ; and ( 2 ) To identify the effective strategies that facilitate positive clinical and humanistic outcomes in this setting . Method A systematic review of r and omized controlled trials evaluating self-management support interventions was conducted following the Cochrane h and book & PRISMA guidelines . Published literature was systematic ally search ed from inception to June 2019 in PubMed , Scopus and Web of Science . Eligible studies assessed the effectiveness of individualized interventions with follow-up , delivered face-to-face to adult patients with any condition in primary care , compared with usual st and ard of care . Matrices were developed that mapped the evidence and components for each intervention . The method ological quality of included studies were appraised . Results 6,510 records were retrieved . 58 studies were included in the final qualitative synthesis . Findings reveal a structured patient-provider exchange is required in primary care ( including a one-on-one patient-provider consultation , ongoing follow up and provision of self-help material s ) . Interventions should be tailored to patient needs and may include combinations of strategies to improve a patient ’s disease or treatment knowledge ; independent monitoring of symptoms , encouraging self-treatment through a personalized action plan in response worsening symptoms or exacerbations , psychological coping and stress management strategies , and enhancing responsibility in medication adherence and lifestyle choices . Follow-up may include tailored feedback , monitoring of progress with respect to patient set healthcare goals , or honing problem-solving and decision-making skills . Theoretical models provided a strong base for effective SMS interventions . Positive outcomes for effective SMS included improvements in clinical indicators , health-related quality of life , self-efficacy ( confidence to self-manage ) , disease knowledge or control . An SMS model has been developed which sets the foundation for the design and evaluation of practical strategies for the construct of self-management support interventions in primary healthcare practice . Conclusions These findings provide primary care professionals with evidence -based strategies and structure to deliver SMS in practice . For this collaborative partnership approach to be more widely applied , future research should build on these findings for optimal SMS service design and upskilling healthcare providers to effectively support patients in this collaborative process BACKGROUND Telemonitoring , the use of communication technology to monitor clinical status , is gaining attention as a strategy to improve the care of patients with heart failure . A system of frequent monitoring could alert clinicians to early heart failure decompensation , providing the opportunity for intervention before patients become severely ill and require hospitalization . Moreover , patients ' participation in a daily monitoring program could have a favorable effect on their health behaviors . The literature on telemonitoring for heart failure , however , is quite limited . METHODS AND MATERIAL S Telemonitoring to Improve Heart Failure Outcomes ( Tele-HF ) is a r and omized , controlled , trial design ed to compare an automated , daily symptom , and self-reported weight monitoring intervention with usual care in reducing ( all-cause ) hospital readmissions and mortality among patients recently hospitalized with decompensated heart failure . The intervention will be implemented and all outcomes will be assessed over a 6-month period . The purpose of the intervention is to collect information about symptoms , clinical status and weight and to engage participants in their own self-care .  Participants are recruited from general cardiology , heart failure specialty , and primary care practice s across the United States . CONCLUSIONS The results of this study may inform future policy decisions regarding implementation of telemonitoring in treatment of heart failure Background Heart failure ( HF ) patients suffer from frequent and repeated hospitalizations , causing a substantial economic burden on society . Hospitalizations can be reduced considerably by better compliance with self-care . Home telemonitoring has the potential to boost patients ’ compliance with self-care , although the results are still contradictory . Objective A r and omized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization . Methods HF patients were eligible whose left ventricular ejection fraction was lower than 35 % , NYHA functional class ≥2 , and who needed regular follow-up . Patients in the telemonitoring group ( n=47 ) measured their body weight , blood pressure , and pulse and answered symptom-related questions on a weekly basis , reporting their values to the heart failure nurse using a mobile phone app . The heart failure nurse followed the status of patients weekly and if necessary contacted the patient . The primary outcome was the number of HF-related hospital days . Control patients ( n=47 ) received multidisciplinary treatment according to st and ard practice s. Patients ’ clinical status , use of health care re sources , adherence , and user experience from the patients ’ and the health care professionals ’ perspective were studied . Results Adherence , calculated as a proportion of weekly su bmi tted self- measurements , was close to 90 % . No difference was found in the number of HF-related hospital days ( incidence rate ratio [IRR]=0.812 , P=.351 ) , which was the primary outcome . The intervention group used more health care re sources : they paid an increased number of visits to the nurse ( IRR=1.73 , P<.001 ) , spent more time at the nurse reception ( mean difference of 48.7 minutes , P<.001 ) , and there was a greater number of telephone contacts between the nurse and intervention patients ( IRR=3.82 , P<.001 for nurse-induced contacts and IRR=1.63 , P=.049 for patient-induced contacts ) . There were no statistically significant differences in patients ’ clinical health status or in their self-care behavior . The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study . Conclusions Home telemonitoring did not reduce the number of patients ’ HF-related hospital days and did not improve the patients ’ clinical condition . Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently , and on this way increased the use of health care re sources . Trial Registration Clinical trials.gov NCT01759368 ; http:// clinical trials.gov/show/NCT01759368 ( Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z ) BACKGROUND Chronic heart failure is associated with frequent hospitalisations which are often due to volume-overload decompensation . Monitoring of intrathoracic impedance , measured from an implanted device , can detect increases in pulmonary fluid retention early and facilitate timely treatment interventions . OBJECTIVE The DOT-HF trial is design ed to investigate if ambulatory monitoring of intrathoracic impedance together with other device-based diagnostic information can reduce morbidity and mortality in patients with chronic heart failure who are treated with cardiac resynchronization therapy ( CRT ) and /or an implantable defibrillator ( ICD ) .  METHODS Approximately 2400 patients will be r and omised in a 1:1 fashion to a management strategy with access to the diagnostic information from the implantable device ( " access arm " ) , or a " control arm " , where this information is not made available . Study subjects fulfil st and ard indications for CRT and /or ICD  as outlined in current guidelines . In the access arm , a fluid alert algorithm is used to give early warning of decreasing intrathoracic impedance indicating a high risk of an impending volume-overload decompensation . The primary endpoint of DOT-HF is the composite of all-cause mortality or heart failure hospitalisation . Secondary and exploratory endpoints include all-cause mortality , the impact on total health care utilization , quality of life and cost effectiveness . The study is expected to close recruitment during 2010 and to report in 2012 BACKGROUND Remote monitoring of heart failure ( HF ) patients may help in the early detection of acute decompensation before the onset of symptoms , providing the opportunity for early intervention to reduce HF-related hospitalizations , improve outcomes , and lower costs . METHODS AND RESULTS MUSIC is a multicenter nonr and omized study design ed to develop and vali date an algorithm for prediction of impending acute HF decompensation with the use of physiologic signals obtained from an external device adhered to the chest . A total of 543 HF patients ( 206 development , 337 validation ) with ejection fraction ≤40 % and a recent HF admission were enrolled .  Patients were remotely monitored for 90 days using a multisensor device . Accounting for device failure and patient withdrawal , 314 patients ( 114 development , 200 validation ) were included in the analysis . Development patient data were used to develop a multiparameter HF detection algorithm . Algorithm performance in the development cohort had 65 % sensitivity , 90 % specificity , and a false positive rate of 0.7 per patient-year for detection of HF events . In the validation cohort , algorithm performance met the prespecified end points with 63 % sensitivity , 92 % specificity , and a false positive rate of 0.9 per patient-year . The overall rate of significant adverse skin response was 0.4 % . CONCLUSION Using an external multisensor monitoring system , an HF decompensation prediction algorithm was developed that met the prespecified performance end point . Further studies are required to determine whether the use of this system will improve patient outcomes Changes in intrathoracic impedance ( Z ) leading to crossing of a derived fluid index ( FI ) threshold has been associated with heart failure ( HF ) hospitalization . The authors developed a remote monitoring program as part of HF disease management and prospect ively examined the feasibility and re source utilization of monitoring individuals with an implanted device capable of measuring Z. An HF nurse analyzed all transmitted data daily , as they were routinely uploaded as part of quarterly remote device monitoring , and called the patient if the FI crossed the threshold ( arbitrarily defined at 60 Omega ) to identify clinical ly relevant events ( CREs ) that occurred during this period ( eg , worsening dyspnea or increase in edema or weight ) . A total of 400 uploads were completed during the 4-month study period . During this period , 34 patients ( 18 % ) had an FI threshold crossing , averaging 0.52 FI threshold crossings per patient-year . Thirty-two of 34 patients contacted by telephone ( 94 % ) with FI threshold crossing had evidence of CREs during this period . However , only 6 ( 18 % ) had HF hospitalizations , 19 ( 56 % ) had reported changes in HF therapy , and 13 ( 38 % ) reported drug and /or dietary plan nonadherence . The average data analysis time required was 30 min daily when focusing on those with FI threshold crossing , averaging 8 uploads for review per working day and 5 telephone follow-ups per week . Our pilot observations suggested that Internet-based remote monitoring of Z trends from existing device interrogation uploads is feasible as part of a daily routine of HF disease management BACKGROUND Decompensated heart failure ( HF ) is associated with unacceptable morbidity and mortality risks . Recent implantable technology advancements allow frequent filling pressure monitoring and provide insight into HF pathophysiology and a new tool for HF management . METHODS The CHAMPION trial is a prospect i ve , multicenter , r and omized , single-blind clinical trial testing the hypothesis that HF management guided by frequently assessed pulmonary artery pressures is superior to traditional methods . A total of 550 subjects with New York Heart Association ( NYHA ) functional class III HF were enrolled at 64 sites in the United States . All subjects received the CardioMEMS HF sensor as a permanent pulmonary artery implant and were r and omized to the treatment or the control group before discharge . The treatment group received traditional HF management guided by hemodynamic information from the sensor . The control group received traditional HF disease management . Safety endpoints include freedom from device/system-related complications and freedom from HF sensor failure at 6 months . The efficacy endpoint is a reduction in the rate of HF-related hospitalizations in the treatment group versus the control group at 6 months . CONCLUSIONS The CHAMPION trial will investigate the safety and clinical efficacy of the CardioMEMS hemodynamic monitoring system and may establish this management strategy as a new paradigm for the medical management of patients with symptomatic HF Background Disease management programmes ( DMPs ) have been shown to reduce hospital readmissions and mortality in adults with heart failure ( HF ) , but their effectiveness in elderly patients or in those with major comorbidity is unknown . The Multicenter R and omised Trial of a Heart Failure Management Programme among Geriatric Patients ( HF-Geriatrics ) assesses the effectiveness of a DMP in elderly patients with HF and major comorbidity . Methods / Design Clinical trial in 700 patients aged ≥ 75 years admitted with a primary diagnosis of HF in the acute care unit of eight geriatric services in Spain . Each patient should meet at least one of the following comorbidty criteria : Charlson index ≥ 3 , dependence in ≥ 2 activities of daily living , treatment with ≥ 5 drugs , active treatment for ≥ 3 diseases , recent emergency hospitalization , severe visual or hearing loss , cognitive impairment , Parkinson 's disease , diabetes mellitus , chronic obstructive pulmonary disease ( COPD ) , anaemia , or constitutional syndrome . Half of the patients will be r and omly assigned to a 1-year DMP led by a case manager and the other half to usual care . The DMP consists of an educational programme for patients and caregivers on the management of HF , COPD ( knowledge of the disease , smoking cessation , immunizations , use of inhaled medication , recognition of exacerbations ) , diabetes ( knowledge of the disease , symptoms of hyperglycaemia and hypoglycaemia , self-adjustment of insulin , foot care ) and depression ( knowledge of the disease , diagnosis and treatment ) . It also includes close monitoring of the symptoms of decompensation and optimisation of treatment compliance . The main outcome variables are quality of life , hospital readmissions , and overall mortality during a 12-month follow-up . Discussion The physiological changes , lower life expectancy , comorbidity and low health literacy associated with aging may influence the effectiveness of DMPs in HF . The HF-Geriatrics study will provide direct evidence on the effect of a DMP in elderly patients with HF and high comorbidty , and will reduce the need to extrapolate the results of clinical trials in adults to elderly patients .Trial registration ( Clinical Trials.gov number , NCT01076465 ) Background  Readmission rates for patients with heart failure are a major concern for hospitals worldwide . The importance of patient education and a structured care plan to ease the transition from hospital to home has been the focus of many intervention strategies to reduce readmission rates . The use of transitioning of care plans is believed to improve medication reconciliation , communication , patient education , and follow‐up . To date , the evidence has not been systematic ally evaluated to support the effectiveness of a nurse coordinated transitioning of care for patients with heart failure in reducing readmission rates . Objective The objective of the systematic review was to identify the best available evidence on the effectiveness of nurse coordinated transitioning of care between hospital and home on hospital readmission rates for all causes in adult patients hospitalised with heart failure . Search strategy The search strategy aim ed to find both published and unpublished studies in the English language from January 1975 through July 2010 . A search of MEDLINE , CINAHL , PsycINFO , Health source Nursing/academic edition , EMBASE , the Cochrane Library , and the Joanna Briggs Institute Library of Systematic Review s was conducted followed by a reference search of relevant studies . The initial key words search ed were : heart failure , readmission , and transitional care . Inclusion criteria R and omised controlled trials that evaluated the effect of nurse coordinated transitioning of care from hospital to home in adult patients with heart failure on  readmission  rates were selected . The outcome was defined as hospital readmissions for all causes following an initial admission for heart failure . Data collection and analysis Studies selected for retrieval were critically evaluated by two independent review ers for method ological validity using st and ardised critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument ( JBI‐MAStARI ) . Data were extracted and analysed using the JBI‐MAStARI program . Results A total of 16 r and omised controlled studies were included . Ten of the 16 studies included in the review show that a nurse led transitioning of care intervention can reduce the rate of readmission for patients with heart failure . Interventions utilising home visits , or home visits coupled with telephone follow‐up , show a more favourable reduction in readmission rates . Conclusions Reduced readmissions occur when transitioning of care interventions are carried out by a heart failure trained nurse who conducts at least one home visit and follows the patient at least weekly for a minimum of 30 days post discharge with either additional home visits or telephone contact . Implication s for practice This review supports the development of a nurse coordinated transitioning of care plan which will require improvements in communication , in addition to changes in health policy and payment systems that align incentives and performance measures in caring for patients with heart failure . Implication s for research Future research should evaluate the effect of the intensity and duration of the transitioning of care intervention on readmission rates in a large r and omised control trial on an adult population with heart failure to determine the ideal frequency and duration of the post discharge interventions OBJECTIVES We sought to identify whether home telemonitoring ( HTM ) improves outcomes compared with nurse telephone support ( NTS ) and usual care ( UC ) for patients with heart failure who are at high risk of hospitalization or death . BACKGROUND Heart failure is associated with a high rate of hospitalization and poor prognosis . Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises . METHODS Patients with a recent admission for heart failure and left ventricular ejection fraction ( LVEF ) < 40 % were assigned r and omly to HTM , NTS , or UC in a 2:2:1 ratio . HTM consisted of twice-daily patient self-measurement of weight , blood pressure , heart rate , and rhythm with automated devices linked to a cardiology center . The NTS consisted of specialist nurses who were available to patients by telephone . Primary care physicians delivered UC . The primary end point was days dead or hospitalized with NTS versus HTM at 240 days . RESULTS Of 426 patients r and omly assigned , 48 % were aged > 70 years , mean LVEF was 25 % ( SD , 8) and median plasma N-terminal pro-brain natriuretic peptide was 3,070 pg/ml ( interquartile range 1,285 to 6,749 pg/ml ) . During 240 days of follow-up , 19.5 % , 15.9 % , and 12.7 % of days were lost as the result of death or hospitalization for UC , NTS , and HTM , respectively ( no significant difference ) . The number of admissions and mortality were similar among patients r and omly assigned to NTS or HTM , but the mean duration of admissions was reduced by 6 days ( 95 % confidence interval 1 to 11 ) with HTM . Patients r and omly assigned to receive UC had higher one-year mortality ( 45 % ) than patients assigned to receive NTS ( 27 % ) or HTM ( 29 % ) ( p = 0.032 ) . CONCLUSIONS Further investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure AIMS Heart failure chiefly affects the elderly , with frequent emergency admissions . Telemonitoring can identify worsening heart failure but previous r and omized trials have enrolled selected patient population s. The Home-HF study examined the impact of home telemonitoring on typical heart failure patients discharged from three acute hospitals in North West London , UK . METHODS AND RESULTS Patients hospitalized with heart failure were r and omized to telemonitoring or usual specialist care . Primary outcome measures were days alive and out of hospital . Secondary outcome measures were number and duration of heart failure hospitalizations , clinic visits , and quality of life .  We recruited 182 patients . There was no difference in the primary outcome measure in the two groups , but there were significantly fewer unplanned hospitalizations for heart failure decompensation , and a reduction in clinic and emergency room visits in the telemonitoring group . There was no statistically significant difference in the mean direct health service costs . CONCLUSION Home telemonitoring in a typical elderly population of heart failure patients produces a similar outcome to ' usual ' specialist care , but reduces clinic and emergency room visits and unplanned heart failure rehospitalizations at little additional cost . This method of disease monitoring may allow specialist services to increase the number of patients under their care ABSTRACT Aim . To see if home telemonitors reduce healthcare use in those with optimized chronic obstructive pulmonary disease ( COPD ) . Methods . We r and omized 40 stable patients with moderate to severe COPD , who had completed at least 12 sessions of outpatient pulmonary rehabilitation ( PR ) , to receive st and ard care ( Controls ) for 52 weeks or st and ard care plus Docobo HealthHUB monitors at home for 26 weeks followed by 26 weeks st and ard care ( Tm Group ) . During the monitoring period , the Tm Group completed  symptoms and physical observations  twice daily which were stored and then uploaded at 2 am through a freephone l and line . Nurses could access the data through a secure web site and received alerting e-mails if certain combinations of data occurred . Results . There were fewer primary care contacts for chest problems ( p < 0.03 ) in the Tm group , but no differences between the groups in emergency room visits , hospital admissions , days in hospital or contacts to the specialist COPD community nurse team , during the monitoring period . After the monitors were removed , there were no differences between the groups for any of the health care contacts ( p > 0.20 throughout ) . Conclusion . In stable , optimized COPD patients who have already completed PR , telemonitoring in addition to best care , reduces primary care chest contacts but not hospital or specialist team utilization Background The importance of comprehensive discharge planning plus post discharge support intervention studies have been advocated for patients with heart failure .  Telephone‐based post‐discharge nursing care was reported as a significant nursing care approach that is believed to promote continuity of care . However , there is a lack of systematic ally examined evidence to support the effectiveness of nurse‐led telephone‐based post‐discharge care for the heart failure patients . Objective The purpose of this study was to examine the best available evidence to determine the effectiveness of telephone‐based post‐discharge nursing care of patient with HF and to quantify the effect on all‐cause readmission rates of these patients . Search strategy A thorough search of published and unpublished literature was conducted from 1990 to 2009 . First , computer data bases such as CINAHL , MEDLINE , COCHRANE EMBASE , and Dissertation Abstract s International were included and then , reference search was conducted with relevant studies . Initial keywords were “ readmission , ” “ heart failure , ” “ * tele * ” , “ nurs * , “ post‐discharge ” , telephone‐based . ” Selection criteria R and omized controlled trial studies using the telephone‐based post‐discharge nursing care was selected . Outcome was defined as frequency of unplanned HF symptoms associated all‐cause hospital readmission rate during the 6 months after discharge . Data collection and analysis Included studies were critically evaluated for method ological quality by independent two review ers . Data were extracted and then analyzed using the JBI‐MASTARI and the RevMan 5 program . Main results A total of 10 r and omized controlled trial studies were included for this study . The study result showed that telephone‐based post‐discharge nursing care was a significant intervention especially decreasing hospital readmission rate among HF patients . Conclusion The findings of this review suggest a positive effect of telephone‐based post‐discharge nursing care and that it is an effective intervention in decreasing readmission rate among HF patients . Implication s for practice / research The results of this systematic review indicate the need for well design ed studies that examine other aspects of post‐discharge nursing telephone interventions to decrease hospital readmission rate among HF patients including : cost‐effectiveness , feasibility and appropriateness Background In heart failure ( HF ) patients with implantable cardioverter defibrillators ( ICD ) or cardiac resynchronisation therapy defibrillators ( CRT-D )  , remote monitoring has been shown to result in at least non-inferior outcomes relative to in-clinic visits . We aim ed to provide further evidence for this effect , and to assess whether adding telephone follow-ups to remote follow-ups influenced outcomes . Methods InContact was a prospect i ve , r and omised , multicentre study . Subjects receiving quarterly automated follow-up only ( telemetry group )  were compared to those receiving personal physician contact .  Personal contact patients were further divided into those receiving automated follow-up plus a telephone call ( remote+phone subgroup ) or in-clinic visits only . Results Two hundred and ten patients underwent r and omisation ( telemetry n = 102 ; personal contact n = 108 [ remote+phone : n = 53 ; visit : n = 55 ] ) . Baseline characteristics were comparable between groups and subgroups . Over 12 months , 34.8 % of patients experienced deterioration of their Packer Clinical Composite Response , with no significant difference between the telemetry group and personal care ( p > 0.999 ) , remote+phone ( p = 0.937 ) or visit ( p = 0.940 ) patients ; predefined non-inferiority criteria were met . Mortality rates ( 5.2 % overall ) were comparable between groups and subgroups ( p = 0.832/p = 0.645 ) , as were HF-hospitalisation rates ( 11.0 % overall ; p = 0.605/p = 0.851 ) . The proportion of patients requiring ≥1 unscheduled follow-up was nominally higher in telemetry and remote+phone groups ( 42.2 and 45.3 % ) compared to the visit group ( 29.1 % ) . Overall , ≥ 1 ICD therapy was delivered to 15.2 % of patients . Conclusion In HF patients with ICDs/CRT-Ds , quarterly remote follow-up only over 12 months was non-inferior to regular personal contact . Addition of quarterly telephone follow-ups to remote monitoring does not appear to offer any clinical advantage . Trial registration clinical trials.gov : NCT01200381 ( retrospectively registered on September 13th 2010 ) OBJECTIVES To determine whether 30-day readmissions were associated with presence of cognitive impairment more in elderly adults with heart failure ( HF ) than in those with other diagnoses and whether medical teams recognized cognitive impairment . DESIGN One-year prospect i ve cohort quality improvement program of cognitive screening and retrospective chart review of documentation and outcomes . SETTING Academic tertiary care hospital medical unit with a cardiovascular focus and an enhanced discharge program of individualized patient education . PARTICIPANTS Individuals aged 70 and older screened before home discharge ( 241 admission encounters ; 121 with HF as a primary diagnosis , 120 without ) . The HF cohort included individuals with preserved and reduced ejection fraction . Individuals who had undergone transplantation , ventricular assist device implantation , or hemodialysis or who had a primary oncology diagnosis or hospice referral were excluded . MEASUREMENTS  Mini-Cog  administered 48 hours or less before discharge , 30-day all-cause readmission rates , documentation of dementia or cognitive impairment , and caregiver education . RESULTS Mini-Cog scores were less than 4 ( indicating cognitive impairment ) in 157 encounters ( 82 ( 67.7 % ) with HF , 75 ( 62.5 % ) without ) . Mini-Cog scores were similar in rate and distribution between groups . Individuals with HF and cognitive impairment had a significantly higher 30-day readmission rate than did the other groups ( 26.8 % vs 13.2 % ; P = .01 ; HF , no cognitive impairment , 12.8 % ; no HF , no cognitive impairment , 13.3 % ; cognitive impairment , no HF , 13.3 % ) . In individuals with HF and cognitive impairment , those with documented caregiver education had lower readmission rates than those without ( 14.3 % vs 36.2 % ; P = .03 ) . Fewer than 9 % had documentation of cognitive impairment in the medical record . CONCLUSION Cognitive impairment , which is frequently undocumented , may indicate greater risk of readmission for individuals with HF than those without . Screening for cognitive impairment , adapting discharge for it , and involving family and caregivers in discharge education may help reduce readmissions BACKGROUND Heart failure ( HF ) remains a condition with high morbidity and mortality . We tested a telephone support strategy to reduce major events in rural and remote Australians with HF , who have limited healthcare access . Telephone support comprised an interactive telecommunication software tool ( TeleWatch ) with follow-up by trained cardiac nurses . METHODS Patients with a general practice ( GP ) diagnosis of HF were r and omized to usual care ( UC ) or UC and telephone support intervention ( UC+I ) using a cluster design involving 143 GPs throughout Australia . Patients were followed up for 12 months . The primary endpoint was the Packer clinical composite score . Secondary endpoints included hospitalization for any cause , death or hospitalization , as well as HF hospitalization . RESULTS Four hundred and five patients were r and omized to CHAT . Patients were well matched at baseline for key demographic variables . The primary endpoint of the Packer score was not different between the two groups ( P = 0.98 ) , although more patients improved with UC+I. There were fewer patients hospitalized for any cause ( 74 vs. 114 , adjusted HR 0.67 [ 95 % CI 0.50 - 0.89 ] , P = 0.006 ) and who died or were hospitalized ( 89 vs. 124 , adjusted HR 0.70 [ 95 % CI 0.53 - 0.92 ] , P = 0.011 ) , in the UC+I vs. UC group . HF hospitalizations were reduced with UC+I ( 23 vs. 35 , adjusted HR 0.81 [ 95 % CI 0.44 - 1.38 ] ) , although this was not significant ( P = 0.43 ) . There were 16 deaths in the UC group and 17 in the UC+I group ( P = 0.43 ) . CONCLUSIONS Although no difference was observed in the primary endpoint of CHAT ( Packer composite score ) , UC+I significantly reduced the number of HF patients hospitalized among a rural and remote cohort . These data suggest that telephone support may be an efficacious approach to improve clinical outcomes in rural and remote HF patients Objective Older adults with chronic kidney disease have a high rate of uncontrolled hypertension . Home monitoring of  blood pressure ( BP ) is an integral part of management , but requires that patients bring records to clinic visits . Telemonitoring interventions , however , have not targeted older , less technologically-skilled population s. Methods Veterans with stage 3 or greater chronic kidney disease and uncontrolled hypertension were r and omized to a novel telemonitoring device pairing a Bluetooth-enabled BP cuff with an Internet-enabled hub , which wirelessly transmitted readings ( n=28 ) , or usual care ( n=15 ) . Home recordings were review ed weekly and telemonitoring participants were contacted if BP was above goal . The prespecified primary endpoints were improved data exchange and device acceptability . Secondary endpoint was BP change . Results Forty-three participants ( average age 68 years , 75 % white ) completed the 6-month study . Average start-of- study BP was 147/78 mmHg . Those in the intervention arm had a median of 29 ( IQR 22 , 53 ) transmitted BP readings per month , with 78 % continuing to use the device regularly , whereas only 20 % of those in the usual care group brought readings to in-person visits . The median number of telephone contacts triggered by the wireless monitoring was 2 ( IQR 1 , 4 ) per patient . Both groups had a significant improvement in systolic BP ( P<0.05 , for both changes ) ; systolic BP fell a median of 13 mmHg in monitored participants compared with 8.5 mmHg in usual care participants ( P for comparison 0.31 ) . Conclusion This low-cost wireless monitoring strategy led to greater sharing of data between patients and clinic and produced a trend toward improvements in BP control over usual care at 6 months BACKGROUND Despite the availability of proven therapies , outcomes in patients with heart failure ( HF ) remain poor . In this 2-stage , multicenter trial , we evaluated the effect of a disease management program on clinical and economic outcomes in patients with HF . METHODS AND RESULTS In Stage 1 , a pharmacist or nurse assessed each patient and made recommendations to the physician to add or adjust angiotensin-converting enzyme ( ACE ) inhibitors and other HF medications . Before discharge ( Stage 2 ) , patients were r and omized to a patient support program ( PSP ) ( education about HF , self-monitoring , adherence aids , newsletters , telephone hotline , and follow-up at 2 weeks , then monthly for 6 months after discharge ) or usual care . In Stage 1 ( 766 patients )  ACE inhibitor use increased from 58 % on admission to 83 % at discharge ( P < .0001 ) , and the daily dose ( in enalapril equivalents ) increased from 11.3 + /- 8.8 mg to 14.5 + /- 8.8 mg ( P < .0001 ) . In Stage 2 ( 276 patients ) there was no difference in ACE inhibitor adherence , but a reduction in cardiovascular-related emergency room visits ( 49 versus 20 , P = .030 ) , hospitalization days ( 812 versus 341 , P = .003 ) , and cost of care ( 2,531 Canadian dollars less per patient ) in favor of the PSP . CONCLUSION Simple interventions can improve ACE inhibitor use and patient outcomes BACKGROUND Although disease management programs have been shown to provide a number of clinical benefits to patients with heart failure ( HF ) , the incremental impact of an automated home monitoring ( AHM ) system on health-related quality of life ( HRQL ) is unknown . METHODS AND RESULTS We performed a prospect i ve r and omized investigation , examining the additive value of AHM to a previously described nurse-directed HF disease management program ( SPAN-CHF ) , with attention to HRQL , in patients with a recent history of decompensated HF . A total of 188 patients were r and omized to receive the SPAN-CHF intervention for 90 days , either with ( AHM group ) or without ( NAHM , st and ard-care group ) AHM , with a 1:1 r and omization ratio after HF-related hospitalization . HRQL , measured by the Minnesota Living With Heart Failure Question naire ( MLHFQ ) ( Physical , Emotional , and Total scores on MLHFQ ) was assessed at 3 time points : baseline , 45 days , and 90 days . Although both treatments ( AHM and NAHM ) improved HRQL at 45 and 90 days compared with baseline with respect to Physical , Emotional , and Total domain scales , no significant difference emerged between AHM and NAHM groups . CONCLUSIONS AHM and NAHM treatments demonstrated improved HRQL scores at 45 and 90 days after baseline assessment . When comparing 2 state-of the-art disease management programs regarding HRQL outcomes , our results did not support the added value of AHM BACKGROUND A disease management program can reduce mortality and rehospitalization of patients with heart failure ( HF ) , but little is known about whether it can improve psychological status . The purpose of this study was to determine the effects of home-based disease management on the psychological status of patients with HF . METHODS AND RESULTS We r and omly assigned patients hospitalized for HF to undergo either  home-based disease management ( n=79 ) or usual care ( n=82 ) . The mean age of the study patients was 76 years , 30 % were female , and 93 % were in NYHA class I or II .  Home-based disease management was delivered by nurses via home visit and telephone follow-up to monitor symptoms and body weight and to educate patients . The primary endpoint was psychological status , including depression and anxiety assessed by the Hospital Anxiety and Depression Scale during follow-up of 1 year . Secondary endpoints included quality of life , all-cause death and hospitalization for HF . The intervention group had significantly lower depression ( P=0.043 ) and anxiety ( P=0.029 ) scores than the usual-care group . There were no significant differences in all-cause death [ hazard ratio ( HR ) 1.02 , 95 % confidence interval ( CI ) 0.37 - 2.61 , P=0.967 ] . However , hospitalization for HF was significantly lower in the intervention group than in the usual-care group ( HR 0.52 , 95 % CI 0.27 - 0.96 , P=0.037 ) . CONCLUSIONS Home-based disease management improved psychological status and also reduced rehospitalization for HF in patients with HF AIMS AND OBJECTIVES This r and omised controlled trial was conducted to estimate the cost-effectiveness of a nurse-led education and psychosocial support programme for patients with heart failure ( HF ) and their partners . BACKGROUND There are few studies evaluating cost-effectiveness of interventions among HF patient-partner dyads . METHODS Dyads r and omised to the experimental group received nurse-led counselling , computer-based education and written material s aim ed at developing problem-solving skills at two , six and 12 weeks after hospitalisation with HF exacerbation . The dyads in the control group received usual care . A cost-effectiveness analysis that included costs associated with staff time to deliver the intervention and travel costs was conducted at 12 months . Quality -adjusted life-year ( QALY ) weights for patients and partners were estimated by SF-6D . RESULTS A total of 155 dyads were included . The intervention cost was € 223 per patient . Participants in both groups showed improvements in QALY weights after 12 months . However , no significant difference in QALY weights was found between the patients in the two groups , nor among their partners . CONCLUSION The intervention was not proven cost-effective , neither for patients nor for partners . The intervention , however , had trends ( but not significant ) effects on the patient-partner dyads , and by analysing the QALY gained from the dyad , a reasonable mean cost-effectiveness ratio was achieved . RELEVANCE TO CLINICAL PRACTICE The study shows trends of a cost-effective education and psychosocial care of HF patient-partner dyads BACKGROUND Prior studies suggest that disease management programs may be effective in improving clinical outcomes in patients with heart failure ( HF ) . However , the use of these programs in setting s with limited sources and among diverse population is not know . Thus the present study was design ed to assess the impact of a computer-based home disease management program ( Alere DayLink HF Monitoring System [ HFMS ] ) on the clinical outcomes of Medicare beneficiaries with HF who were elderly , women , and non-white males who received the care from a community-based primary care practitioner . METHODS AND RESULTS The Heart Failure Home Care ( HFHC ) trial was a multicenter , r and omized , controlled trial of HFMS versus st and ard heart failure care ( SC : enhanced patient education , education to clinicians , and follow-up ) . The primary study end point was treatment failure , defined as a composite of cardiovascular death or rehospitalization for heart failure within 6 months of enrollment . Among patients rehospitalized for HF , length of hospital stay was also considered a primary end point . A total of 315 patients were r and omized : 160 to HFMS and 155 to SC . Although the incidence of the primary outcome was somewhat higher in the SC arm ( 28.8 % versus 21.2 % , P = .15 ) , the difference was not statistically different . The length of hospital stay was also similar in both groups . CONCLUSIONS Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program in patients with HF who are elderly , women and non-Caucasian males and receive the care from a community-based primary care practitioner BACKGROUND Half of patients with hypertension have poor  blood pressure ( BP ) control . Recent models for treating hypertension have integrated disease monitoring and telephone-based interventions delivered in patients ' homes . This study evaluated the costs of the Hypertension Intervention Nurse Telemedicine Study ( HINTS ) , aim ed to improve BP control  in veterans . METHODS Eligible veterans were r and omized to either  usual care  or 1 of 3 telephone-based intervention groups using home BP telemonitoring : ( 1 ) behavioral management , ( 2 ) medication management , or ( 3 ) combined . Intervention costs were derived from information collected during the trial . Direct medical costs ( inpatient , outpatient , and outpatient pharmacy , including hypertension-specific pharmacy ) at 18 months by group were calculated using Veterans Affairs ( VA ) Decision Support System data . Bootstrapped CIs were computed to compare intervention and medical costs between intervention groups and usual care . RESULTS Patients receiving behavior or medication management showed significant gains in BP control at 12 months ; there were no differences in BP control at 18 months . In subgroup analysis , patients with poor baseline BP control receiving combined intervention significantly improved BP at 12 and 18 months . In overall and subgroup sample s , average intervention costs were similar in the 3 study arms , and at 18 months , there were no statistically significant differences in direct VA medical costs or total VA costs between treatment arms and usual care . CONCLUSIONS To optimize investment in telephone-based home interventions such as the HINTS , it is important to identify groups of patients who are most likely to benefit from more intensive home BP management OBJECTIVES Persons with concomitant heart failure ( HF ) and diabetes mellitus ( DM ) have complicated , often competing , self-care expectations and treatment regimens that may reduce quality of life ( QOL ) . This r and omized controlled trial tested an integrated self-care intervention on outcomes of HF and DM QOL , physical function , and physical activity ( PA ) . METHODS AND RESULTS Participants with HF and DM ( n = 134 ; mean age 57.4 ± 11 years , 66 % men , 69 % minority ) were r and omized to usual care ( control ) or intervention . The control group received st and ard HF and DM educational brochures with follow-up telephone contact . The intervention group received education and counseling on combined HF and DM self-care ( diet , medications , self-monitoring , symptoms , and PA ) with follow-up home visit and telephone counseling . Measures included question naires for HF- and DM-specific and overall QOL , PA frequency , and physical function ( 6-min walk test [ 6MWT ] ) and were obtained at baseline and 3 and 6 months . Analysis included mixed models with a priori post hoc tests . Adjusting for age , body mass index , and comorbidity , the intervention group improved in HF total ( P = .002 ) and physical ( P < .001 ) QOL scores at 3 months with retention of improvements at 6 months , improved in emotional QOL scores compared with control at 3 months ( P = .04 ) , and improved in health status ratings ( P = .04 ) at 6 months compared with baseline . The intervention group improved in 6MWT distance ( 924 ft to 952 ft ; P = .03 ) whereas the control group declined ( 834 ft to 775 ft ; F1,63 = 6.86 ; P = .01 ) . The intervention group increased self-reported PA between baseline and 6 months ( P = .01 ) . CONCLUSIONS An integrated HF and DM self-care  intervention improved perceived HF and general QOL but not DM QOL . Improved physical functioning and self-reported PA were also observed with the integrated self-care intervention . Further study of the HF and DM integrated self-care intervention on other outcomes , such as hospitalization and cost , is warranted OBJECTIVE This study compared the effectiveness and cost/utility ratio between a heart failure ( HF ) management program delivered by day-hospital ( DH ) and usual care in chronic heart failure ( CHF ) out patients . BACKGROUND Previous studies showed that about 50 % of readmissions for CHF can be prevented by a multidisciplinary approach . However , the performance , effectiveness , and cost/utility ratio of a process of HF outpatient management related to evidence -based medicine have not been considered . METHODS A total of 234 prospect i ve patients discharged by a HF Unit were r and omized to two management strategies : 122 patients to usual community care and 112 patients to a HF management program delivered by the DH .  Management ( rate of readmissions , therapeutic interventions ) , functional parameters ( New York Heart Association [ NYHA ] functional class , left ventricular diameters , and ejection fraction , deceleration time of early diastolic mitral flow , peak oxygen uptake , and mitral regurgitation ) and hard outcomes ( cardiac death and urgent cardiac transplantation ) were evaluated . The cost/utility ratios of the two strategies were compared . RESULTS After 12 + /- 3 months of follow-up , the individual rate access in DH was 5.5 + /- 3.8 days . The DH subjects were readmitted to the hospital less frequently than were the usual-care group patients ( 13 vs. 78 , p < 0.00001 ) . Patients allocated to usual-care management showed heterogeneous changes in NYHA functional class ( 13 % improved and 16 % worsened p = NS ) ; In contrast , the DH group showed significant changes in NYHA functional class ( 23 % improved and 11 % worsened , p < 0.009 ) . Hard cardiac events in the one-year follow-up occurred in 25/234 ( 10.6 % ) patients ; cardiac death occurred in 21/122 ( 17.2 % ) of the community group and in 3/112 ( 2.7 % ) in the DH group ( p < 0.0007 ) . One DH patient underwent urgent transplantation . Comparison of the two managerial models by Cox regression analysis showed that DH management significantly protected against the appearance of hard events ( relative risk [ RR ] 0.17 ; confidence interval [ CI ] 0.06 to 0.66 ) . The cost/utility ratio of the two management strategies was similar ( usual care $ 2,409 vs. DH $ 2,244 ) . The incremental analysis revealed a cost savings of $ 1,068 for each quality -adjusted life year gained . The cost/utility ratio for the integration of DH management of CHF was $ 19,462 ( CI $ 13,904 to $ 34,048 ) . CONCLUSIONS A heart failure outpatient management program delivered by a DH can reduce mortality and morbidity of CHF patients . This management strategy is cost-effective and has an equitable value from a societal point of view Background .The high cost of caring for patients with congestive heart failure ( CHF ) results primarily from frequent hospital readmissions for exacerbations . Home nurse visits after discharge can reduce readmissions , but the intervention costs are high . Objectives .To compare the effectiveness of three hospital discharge care models for reducing CHF-related readmission charges : 1 ) home telecare delivered via a 2-way video-conference device with an integrated electronic stethoscope ; 2 ) nurse telephone calls ; and 3 ) usual outpatient care . Research Design . One-year r and omized trial . Subjects . English-speaking patients 40 years of age and older with a primary hospital admission diagnosis of CHF . Measures .Our primary outcome was CHF-related readmission charges during a 6-month period after r and omization . Secondary outcomes included all-cause readmissions , emergency department ( ED ) visits , and associated charges . Results .Thirty-seven subjects were r and omized : 13 to home telecare , 12 each telephone care and 12 to usual care .  Mean CHF-related readmission charges were 86 % lower in the telecare group ( $ 5850 , SD $ 21,094 ) and 84 % lower in the telephone group ( $ 7320 , SD $ 24,440 ) than in the usual care group ( $ 44,479 , SD $ 121,214 ) . However , the between-group difference was not statistically significant . Both intervention groups had significantly fewer CHF-related ED visits ( P = 0.0342 ) and charges ( P = 0.0487 ) than the usual care group . Trends favoring both interventions were noted for all other utilization outcomes . Conclusions .Substantial reductions in hospital readmissions , emergency visits , and cost of care for patients with CHF might be achieved by widespread deployment of distance technologies to provide posthospitalization monitoring . Home telecare may not offer incremental benefit beyond telephone follow-up and is more expensive Aim : To determine whether an intensive intervention at a heart failure ( HF ) clinic by a combination of a clinician and a cardiovascular nurse , both trained in HF , reduces the incidence of hospitalisation for worsening HF and /or all-cause mortality ( primary end point ) and improves functional status ( including left ventricular ejection fraction , New York Heart Association ( NYHA ) class and quality of life ) in patients with NYHA class III or IV . Setting : Two regional teaching hospitals in The Netherl and s. Methods : 240 patients were r and omly allocated to the 1-year intervention  ( n = 118 ) or usual care ( n = 122 ) . The intervention consisted of 9 scheduled patient contacts — at day 3 by telephone , and at weeks 1 , 3 , 5 , 7 and at months 3 , 6 , 9 and 12 by a visit — to a combined , intensive physician- and -nurse-directed HF outpatient clinic , starting within a week after hospital discharge from the hospital or referral from the outpatient clinic . Verbal and written comprehensive education , optimisation of treatment , easy access to the clinic , recommendations for exercise and rest , and advice for symptom monitoring and self-care were provided . Usual care included outpatient visits initialised by individual cardiologists in the cardiology departments involved and applying the guidelines of the European Society of Cardiology . Results : During the 12-month study period , the number of admissions for worsening HF and /or all-cause deaths in the intervention group was lower than in the control group ( 23 vs 47 ; relative risk ( RR ) 0.49 ; 95 % confidence interval ( CI ) 0.30 to 0.81 ; p = 0.001 ) . There was an improvement in left ventricular ejection fraction ( LVEF ) in the intervention group ( plus 2.6 % ) compared with the usual care group ( minus 3.1 % ; p = 0.004 ) . Patients in the intervention group were hospitalised for a total of 359 days compared with 644 days for those in the usual care group . Beneficial effects were also observed on NYHA classification , prescription of spironolactone , maximally reached dose of β-blockers , quality of life , self-care behaviour and healthcare costs . Conclusion : A heart failure clinic involving an intensive intervention by both a clinician and a cardiovascular nurse substantially reduces hospitalisations for worsening HF and /or all-cause mortality and improves functional status , while decreasing healthcare costs , even in a country with a primary -care-based healthcare system Heart failure ( HF ) is the leading cause of rehospitalization in older adults . The purpose of this pilot study was to examine whether telemonitoring by an advanced practice nurse reduced subsequent hospital readmissions , emergency department visits , costs , and risk of hospital readmission for patients with HF . One hundred two patient/caregiver dyads were r and omized into 2 groups postdischarge ; 84 dyads completed the study . Hospital readmissions , emergency department visits , costs , and days to readmission were abstract ed from medical records . Participants were interviewed soon after discharge and 3 months later about effects of telemonitoring on depressive symptoms , quality of life , and caregiver mastery . There were no significant differences due to telemonitoring for any outcomes . Caregiver mastery , informal social support , and electronic home monitoring were not significant predictors for risk of hospital readmission . Further studies should address the interaction between the advanced practice nurse and follow-up intervention with telemonitoring of patients with HF to better target those who are most likely to benefit AIMS Chronic heart failure ( CHF ) patients are frequently rehospitalized within 6 months after an episode of fluid retention . Rehospitalizations are preventable , but this requires an extensive organization of the healthcare system . In this study , we tested whether intensive follow-up of patients through a telemonitoring-facilitated collaboration between general practitioners ( GPs ) and a heart failure clinic could reduce mortality and rehospitalization rate . METHODS AND RESULTS One hunderd and sixty CHF patients [ mean age 76 ± 10 years , 104 males , mean left ventricular ejection fraction ( LVEF ) 35 ± 15 % ] were block r and omized by sealed envelopes and assigned to 6 months of intense follow-up facilitated by telemonitoring ( TM ) or usual care ( UC ) . The TM group measured body weight , blood pressure , and heart rate on a daily basis with electronic devices that transferred the data automatically to an online data base . Email alerts were sent to the GP and heart failure clinic to intervene when pre-defined limits were exceeded . All-cause mortality was significantly lower in the TM group as compared with the UC group ( 5 % vs. 17.5 % , P = 0.01 ) . The total number of follow-up days lost to hospitalization , dialysis , or death was significantly lower in the TM group as compared with the UC group ( 13 vs. 30 days , P = 0.02 ) . The number of hospitalizations for heart failure per patient showed a trend ( 0.24 vs. 0.42 hospitalizations/patient , P = 0.06 ) in favour of TM . CONCLUSION Telemonitoring-facilitated collaboration between GPs and a heart failure clinic reduces mortality and number of days lost to hospitalization , death , or dialysis in CHF patients . These findings need confirmation in a large trial Background There is growing evidence that home telemonitoring can be advantageous in societies with increasing prevalence of chronic diseases . The main objective of this study is to evaluate the effect of a primary care-based telemonitoring intervention on the number and length of hospital admissions . Methods A r and omised controlled trial was carried out across 20 health centres in Bilbao ( Basque Country , Spain ) to assess the impact of home telemonitoring on in-home chronic patients compared with st and ard care . The study lasted for one year . Fifty-eight in-home patients , diagnosed with heart failure ( HF ) and /or chronic lung disease ( CLD ) , aged 14 or above and with two or more hospital admissions in the previous year were recruited . The intervention consisted of daily patient self- measurements of respiratory-rate , heart-rate , blood pressure , oxygen saturation , weight , body temperature and the completion of a health status question naire using PDAs . Alerts were generated when pre-established thresholds were crossed . The control group ( CG ) received usual care . The primary outcome measure was the number of hospital admissions that occurred at 12 months post-r and omisation . The impact of telemonitoring on the length of hospital stay , use of other healthcare re sources and mortality was also explored . Results The intervention group ( IG ) included 28 patients and the CG 30 . Patient baseline characteristics were similar in both groups . Of the 21 intervention patients followed-up for a year , 12 had some admissions ( 57.1 % ) , compared to 19 of 22 controls ( 86.4 % ) , being the difference statistically significant ( p = 0.033 , RR 0.66 ; 95%CI 0.44 to 0.99 ) . The mean hospital stay was overall 9 days ( SD 4.3 ) in the IG versus 10.7 ( SD 11.2 ) among controls , and for cause-specific admissions 9 ( SD 4.5 ) vs. 11.2 ( SD 11.8 ) days , both without statistical significance ( p = 0.891 and 0.927 , respectively ) . Four patients need to be telemonitored for a year to prevent one admission ( NNT ) . There were more telephone contacts in the IG than in the CG ( 22.6 -SD 16.1- vs. 8.6 -SD 7.2- , p = 0.001 ) , but fewer home nursing visits ( 15.3 -SD 11.6- vs. 25.4 -SD 26.3- , respectively ) , though the difference was not statistically significant ( p = 0.3603 ) . Conclusions This study shows that telemonitoring of in-home patients with HF and /or CLD notably increases the percentage of patients with no hospital admissions and indicates a trend to reduce total and cause-specific hospitalisations and hospital stay .  Home telemonitoring can constitute a beneficial alternative mode of healthcare provision for medically unstable elderly patients .Trial registration Current Controlled Trials IS RCT OBJECTIVES The purpose of this study was to determine whether a heart failure ( HF ) management strategy using continuous intracardiac pressure monitoring could decrease HF morbidity . BACKGROUND Patients with HF may experience frequent decompensations that require hospitalization despite intensive treatment and follow-up . METHODS The COMPASS-HF ( Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure ) study was a prospect i ve , multicenter , r and omized , single-blind , parallel-controlled trial of 274 New York Heart Association functional class III or IV HF patients who received an implantable continuous hemodynamic monitor . Patients were r and omized to a Chronicle ( Medtronic Inc. , Minneapolis , Minnesota ) ( n = 134 ) or control ( n = 140 ) group . All patients received optimal medical therapy , but the hemodynamic information from the monitor was used to guide patient management only in the Chronicle group . Primary end points included freedom from system-related complications , freedom from pressure-sensor failure , and reduction in the rate of HF-related events ( hospitalizations and emergency or urgent care visits requiring intravenous therapy ) . RESULTS The 2 safety end points were met with no pressure-sensor failures and system-related complications in only 8 % of the 277 patients who underwent implantation ( all but 4 complications were successfully resolved ) . The primary efficacy end point was not met because the Chronicle group had a nonsignificant 21 % lower rate of all HF-related events compared with the control group ( p = 0.33 ) . A retrospective analysis of the time to first HF hospitalization showed a 36 % reduction ( p = 0.03 ) in the relative risk of a HF-related hospitalization in the Chronicle group . CONCLUSIONS The implantable continuous hemodynamic monitor-guided care did not significantly reduce total HF-related events compared with optimal medical management . Additional trials will be necessary to establish the clinical benefit of implantable continuous hemodynamic monitor-guided care in patients with advanced HF Background The benefits of rehabilitation in heart failure ( HF ) patients are well established . Little is known about Nordic walking ( NW ) training in HF patients especially in those with cardiovascular implantable electronic devices ( CIEDs ) . Purpose The purpose of this study was to assess safety , effectiveness , adherence to and acceptance of home-based telemonitored NW in HF patients , including those with CIEDs ( i.e. cardiac resynchronisation therapy , implantable cardioverter-defibrillator ) . Methods The study design was a single-centre , prospect i ve , parallel-group , r and omised ( 2:1 ) , controlled trial among 111 HF patients , New York Heart Association ( NYHA ) II – III ; left ventricular ejection fraction ( EF ) ≤ 40 % . The intervention was a home-based telemonitored eight-week NW ( training group ( TG ) n = 77 ) five times weekly vs usual care alone ( control group ( CG ) n = 34 ) . Outcome measures included a primary end point of functional capacity assessed by peak oxygen consumption ( VO2peak ) . Secondary end points included : workload duration ( t ) in cardiopulmonary exercise test ( CPET ) , six-minute walking test ( 6-MWT ) distance and quality of life ( QoL ) , Medical Outcome Survey Short Form 36 ( SF-36 ) ; safety ; adherence to and acceptance of NW . Measurements were made before and after intervention . Results NW result ed in significant improvement in : VO2peak ( 16.1 ± 4.0 vs 18.4 ± 4.1(ml/kg/min ) , p = 0.0001 ) , t ( 471 ± 141 vs 577 ± 158 ( s ) , p = 0.0001 ) , 6-MWT(428 ± 93 vs 480 ± 87 ( m ) , p = 0.0001 ) and QoL ( 79.0 ± 31.3 vs 70.8 ± 30.3 ( score ) , p = 0.0001 ) . We did not observe favourable results in the CG . The differences between the TG and CG were significant in : ΔVO2peak ( Δ2.0 ± 2.4 vs Δ−0.2 ± 2.1 , p = 0.0004 ) ; Δt ( Δ108 ± 108 vs Δ0.94 ± 109 , p = 0.0031 ) ; Δ6-MWT ( Δ53.8 ± 63.9 vs Δ22.0 ± 68.7 , p = 0.0483 ) . In neither group were there deaths nor necessity for hospitalisation . We did not observe any intervention from CIEDs during NW . All patients in the TG completed rehabilitation and accepted it well . Conclusion In HF patients , including those with CIEDs , home-based telemonitored NW  is safe and effective . NW was well accepted by patients and adherence was high and promising BACKGROUND As the prevalence of heart failure ( HF ) rises sharply , the costs related to the care of these patients increases in parallel . Considering the already limited re sources and manpower , in the future the dem and for care may exceed the supply . Therefore , health care systems are encouraged to develop innovative strategies to deal with the burden of HF to improve the quality of care in order to medical outcomes and patients ' quality of life . For that reason new management systems - such as telemonitoring - have to be explored . OBJECTIVES This paper outlines the study protocol of a tailor-made telemonitoring program in ambulant patients with HF . DESIGN AND METHODS A prospect i ve r and omised controlled trial is carried out at 3 hospitals in the South-Limburg area in the Netherl and s. Primary outcome measures are hospital admissions and cost-effectiveness . Secondary outcomes are effects on therapy compliance , level of disease specific knowledge and quality of life . Also determinants are studied of most and less benefited patients in the intervention group . POWER CALCULATION : It is estimated that 390 patients have to be included in the study , with 185 in each arm . RESULTS Inclusion started in September 2007 with a follow-up time of 12 months . First results are expected at the end of 2010 We evaluated the efficacy of two telehealth applications , delivered by telephone and videophone , for improving outcomes of patients following hospital discharge for an acute exacerbation of heart failure . The outcomes measured were patient self-efficacy , satisfaction with care and knowledge of and compliance with prescribed medications . At hospital discharge , patients were r and omly assigned to either control ( usual care ) , telephone or videophone groups . Study nurses contacted the intervention patients each week for 90 days after discharge . A total of 148 patients were enrolled : 49 were r and omized to usual care , 52 to the videophone intervention and 47 to the telephone intervention . At 90 days , 126 patients ( 85 % ) had completed follow-up ; at 180 days , 109 patients ( 74 % ) had completed follow-up . There were no significant differences between the groups in medication compliance , self-efficacy or satisfaction with care . The intervention group patients were more likely to have had their medications adjusted during the 90-day intervention period . Knowledge scores improved in the intervention group patients , although these scores were lower at enrolment compared to the control group . It is possible that routine monitoring of symptoms by the study nurses led to medication adjustments and accounted for the intervention patients ' significantly delayed time to readmission relative to the control patients Background : The Self-management and Care of Heart Failure through Group Clinics Trial evaluated the effects of multidisciplinary group clinic appointments on self-care skills and rehospitalizations in high-risk heart failure ( HF ) patients . Objective : The purpose of this article is to ( 1 ) describe key Self-management and Care of Heart Failure through Group Clinics Trial group clinic interactive learning strategies , ( 2 ) describe re sources and material s used in the group clinic appointment , and ( 3 ) present results supporting this patient-centered group intervention . Methods : This clinical trial included 198 HF patients ( r and omized to either group clinical appointments or to st and ard care ) . Data were collected from 72 group clinic appointments via patients ’ ( 1 ) group clinic session evaluations , ( 2 ) HF self-care behaviors skills , ( 3 ) HF-related discouragement and quality of life scores , and ( 4 ) HF-related reshopitalizations during the 12-month follow-up . Also , the costs of delivery of the group clinical appointments were tabulated . Results : Overall , patients rated group appointments as 4.8 of 5 on the “ helpfulness ” in managing HF score . The statistical model showed a 33 % decrease in the rate of rehospitalizations ( incidence rate ratio , 0.67 ) associated with the intervention over the 12-month follow-up period when compared with control patients ( & khgr;21 = 3.9 , P = .04 ) . The total cost for implementing 5 group appointments was $ 243.58 per patient . Conclusion : The intervention was associated with improvements in HF self-care knowledge and home care behavior skills and managing their for HF care . In turn , better self-care was associated with reductions in HF-related hospitalizations OBJECTIVE To study the impact of remote patient monitoring ( RPM ) upon the most frequent diagnosis in hospitalized patients over 65 years of age-heart failure ( HF ) . We examined the effect of RPM on hospital utilization and Medicare costs of HF patients receiving home care . MATERIAL S AND METHODS Two studies were simultaneously conducted : A r and omized and a matched-cohort study . In the r and omized study , 168 subjects were r and omly assigned ( after hospitalization ) to home care utilizing  RPM ( live nursing visits and video-based nursing visits ) or to home care receiving live nursing visits only . In the matched-cohort study , 160 subjects receiving home care with RPM ( live nursing visits and video-based nursing visits ) were matched with home care subjects receiving live nursing visits only . RESULTS Regardless of whether outcomes were being analyzed for all subjects ( intention to treat ) or for hospitalized subjects only , hospitalization rates , time to first admission , length of stay , and costs to Medicare did not differ significantly between groups in either study at 30 or 90 days after enrollment . A notable trend , however , emerged across studies : Although time to hospitalization was shorter in the RPM groups than the control groups , RPM groups had lower hospitalization costs . CONCLUSIONS RPM , when utilized in conjunction with a robust management protocol , was not found to significantly differ from live nursing visits in the management of HF in home care . Shorter hospitalization times and lower associated costs may be due to earlier identification of exacerbation . These trends indicate the need for further study Introduction The potential for telehealth-based interventions to provide remote support , education and improve self-management for long-term conditions is increasingly recognised . This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease ( COPD ) by providing personalised self-management information and education . Methods and analysis The EDGE ( sElf management anD support proGrammE ) for COPD is a multicentre , r and omised controlled trial design ed to assess the efficacy of an Internet-linked tablet computer-based intervention ( the EDGE platform ) in improving quality of life in patients with moderate to very severe COPD compared with usual care . Eligible patients are r and omly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based r and omisation system . Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD -related admission and from primary care clinics . Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter . Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables . The primary outcome of quality of life is measured using the St George 's Respiratory Question naire for COPD patients ( SGRQ-C ) baseline , 6 and 12 months . Secondary outcome measures are recorded at these intervals in addition to 3 months . Ethics and dissemination The Research Ethics Committee for Berkshire — South Central has provided ethical approval for the conduct of the study in the recruiting regions . The results of the study will be disseminated through peer review publications and conference presentations . Trial registration Current controlled trials IS RCT N40367841 Introduction Up to half of all smokers develop clinical ly significant chronic obstructive pulmonary disease ( COPD ) . Gaps exist in the implementation and uptake of evidence -based guidelines for managing COPD in primary care . We describe the methodology of a cluster r and omised controlled trial ( c RCT ) evaluating the efficacy and cost-effectiveness of an interdisciplinary model of care aim ed at reducing the burden of smoking and COPD in Australian primary care setting s. Methods and analysis A c RCT is being undertaken to evaluate an interdisciplinary model of care ( RADICALS — Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers ) . General practice clinics across Melbourne , Australia , are identified and r and omised to the intervention group ( RADICALS ) or usual care .  Patients who are current or ex-smokers , of at least 10 pack years , including those with an existing diagnosis of COPD , are being recruited to identify 280 participants with a spirometry-confirmed diagnosis of COPD .  H and held lung function devices are being used to facilitate case-finding . RADICALS includes individualised smoking cessation support , home-based pulmonary rehabilitation and home medicines review . Patients at control group sites receive usual care and Quitline referral , as appropriate . Follow-ups occur at 6 and 12 months from baseline to assess changes in quality of life , abstinence rates , health re source utilisation , symptom severity and lung function . The primary outcome is change in St George ’s Respiratory Question naire score of patients with COPD at 6 months from baseline . Ethics and dissemination This project has been approved by the Monash University Human Research Ethics Committee and La Trobe University Human Ethics Committee ( CF14/1018 – 2014000433 ) . Results of the study will be disseminated in peer- review ed journals and research conferences . If the intervention is successful , the RADICALS programme could potentially be integrated into general practice s across Australia and sustained over time . Trial registration number ACTRN12614001155684 ; Pre- results This article provides information and a commentary on key trials relevant to the pathophysiology , prevention , and treatment of heart failure ( HF ) presented at the European Society of Cardiology Heart Failure meeting held in Gothenburg , Sweden in May 2011 . Unpublished reports should be considered as preliminary , since analyses may change in the final publication . In the TEHAF study , use of the Health Buddy ( ® ) monitoring system failed to reduce the number of HF admissions compared with usual care but a subgroup of patients with more recently diagnosed HF may have benefited . In the WHICH study , some reductions in the rate of hospital stay were observed in patients who underwent a  nurse-led home-based intervention programme following a hospital admission for an acute HF exacerbation , compared with patients who were followed in a specialized outpatient clinic . Results from CARVIVA-HF suggest that ivabradine alone or in combination with carvedilol  is safe and effective for improving exercise capacity and quality of life in HF patients on optimized angiotensin-converting enzyme inhibitor therapy . In the GISSI-HF study there was no difference in atrial fibrillation ( AF ) occurrence between the n-3 polyunsaturated fatty acids and placebo groups . In EMPHASIS-HF the incidence of new onset AF or flutter was reduced in patients with mild HF r and omized to eplerenone compared with placebo PRINCIPLES International guidelines for heart failure ( HF ) care recommend the implementation of inter-professional disease management programmes . To date , no such programme has been tested in Switzerl and . The aim of this r and omised controlled trial ( RCT ) was to test the effect on hospitalisation , mortality and quality of life of an adult ambulatory disease management programme for patients with HF in Switzerl and . METHODS Consecutive patients admitted to internal medicine in a Swiss university hospital were screened for decompensated HF . A total of 42 eligible patients were r and omised to an intervention ( n = 22 ) or usual care group ( n = 20 ) . Medical treatment was optimised and lifestyle recommendations were given to all patients . Intervention patients additionally received a home visit by a HF-nurse , followed by 17 telephone calls of decreasing frequency over 12 months , focusing on self-care . Calls from the HF nurse to primary care physicians communicated health concerns and identified goals of care . Data were collected at baseline , 3 , 6 , 9 and 12 months . Mixed regression analysis ( quality of life ) was used . Outcome assessment was conducted by research ers blinded to group assignment . RESULTS After 12 months , 22 ( 52 % ) patients had an all-cause re-admission or died . Only 3 patients were hospitalised with HF decompensation . No significant effect of the intervention was found on HF related to quality of life . CONCLUSIONS An inter-professional disease management programme is possible in the Swiss healthcare setting but effects on outcomes need to be confirmed in larger studies Background Recent increasing prevalence of heart failure ( HF ) patients leads to an increasing burden to the health care system . Consequently , there is a need for innovative strategies to reduce HF hospitalizations . Methods We performed a multicentre r and omized controlled trial to test the hypothesis that telemonitoring in patients with HF , by means of the Health Buddy ® system ( HB ) , will reduce HF hospitalizations and number of contacts with caregivers as compared to care as usual ( CAU ) during 1 year follow-up , from October 1 , 2007 , through December 31 , 2008 . Results Among 382 patients —197 in the HB and 185 in the CAU-group—226 ( 59 % ) were male , mean age was 71.5 ( SD 11.2 ) , 45.5 % being ≥75 years of age ; 57 % of the patients were in NYHA HF class 2 , 40 % in class 3 and 3 % in class 4 . Both study groups were similar for demographic and clinical characteristics . Mean time to first heart failure related hospitalization was 161 days for the intervention group and 139 days for the usual-care group ; hospitalizations occurred in 18 ( 9.1 % ) compared to 25 patients ( 13.5 % ) respectively ( Kaplan – Meier p=0.151 , hazard ratio 0.65 , CI 0.35–1.17 ) . Combined endpoint of heart failure admission and all cause mortality was similar for both groups ( Kaplan – Meier p=0.641 hazard ratio 0.89 , CI 0.69–1.83 ) . Cox regression analysis disclosed an important interaction between group assignment and heart failure duration , p=0.007 , OR=0.983 , CI 0.970–0.995 indicating a significant decrease in heart failure hospitalizations in the intervention group if heart failure duration was < 18 months , p=0.026 , hazard ratio 0.26 , CI 0.07–0.94 . Contacts with the heart-failure-nurse were mean 1.36 ( range 0–11 ) in the intervention group vs. 1.74 ( 0–8 ) in the usual-care group ( Mann-Whitney p<0.001 ) . Mortality was 18 ( 9.1 % ) in the intervention-group and 12 ( 6.5 % ) in the usual-care-group ( Mann – Whitney p=0.34 , Cox-regression analysis p=0.82 ) . Conclusion Telemonitoring tends to reduce heart failure admissions and decreases contacts with specialized nurses . If heart failure duration is < 18 months heart failure admissions and readmissions are significantly reduced Background . Hospitalization accounts for 70 % of heart failure ( HF ) costs ; readmission rates at 30 days are 24 % and rise to 50 % by 90 days . Agencies anticipate that telehomecare will provide the close monitoring necessary to prevent HF readmissions . Methods and Results . R and omized controlled trial to compare a telehomecare intervention for patients 55 and older following hospital discharge for HF to usual skilled home care .  Primary endpoints were 30- and 60-day all-cause and HF readmission , hospital days , and time to readmission or death . Secondary outcomes were access to care , emergency department ( ED ) use , and satisfaction with care . All-cause readmissions at 30 days ( 16 % versus 19 % ) and over six months ( 46 % versus 52 % ) were lower in the telehomecare group but were not statistically significant . Access to care and satisfaction were significantly higher for the telehomecare patients , including the number of in-person visits and days in home care . Conclusions . Patient acceptance of the technology and current home care policies and processes of care were barriers to gaining clinical effectiveness and efficiency Background — This study was design ed to determine whether physician-led remote telemedical management ( RTM ) compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure ( HF ) . Methods and Results — We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction ⩽35 % and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction ⩽25 % . Patients were r and omly assigned ( 1:1 ) to RTM or usual care . Remote telemedical management used portable devices for ECG , blood pressure , and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers . The primary end point was death from any cause . The first secondary end point was a composite of cardiovascular death and hospitalization for HF . Baseline characteristics were similar between the RTM ( n=354 ) and control ( n=356 ) groups . Of the patients assigned to RTM , 287 ( 81 % ) were at least 70 % compliant with daily data transfers and no break for > 30 days ( except during hospitalizations ) . The median follow-up was 26 months ( minimum 12 ) , and was 99.9 % complete . Compared with usual care , RTM had no significant effect on all-cause mortality ( hazard ratio , 0.97 ; 95 % confidence interval , 0.67 to 1.41 ; P=0.87 ) or on cardiovascular death or HF hospitalization ( hazard ratio , 0.89 ; 95 % confidence interval , 0.67 to 1.19 ; P=0.44 ) . Conclusions — In ambulatory patients with chronic HF  , RTM compared with usual care was not associated with a reduction in all-cause mortality . Clinical Trial Registration : — URL : http://www . Clinical Trials.gov . Unique identifier : NCT00543881 Rationale : Early detection of chronic obstructive pulmonary disease ( COPD ) exacerbations using telemonitoring of physiological variables might reduce the frequency of hospitalization . Objectives : To evaluate the efficacy of home monitoring of lung mechanics by the forced oscillation technique and cardiac parameters in older patients with COPD and comorbidities . Methods : This multicenter , r and omized clinical trial recruited 312 patients with Global Initiative for Chronic Obstructive Lung Disease grade s II to IV COPD ( median age , 71 yr [ interquartile range , 66‐76 yr ] ; 49.6 % grade II , 50.4 % grade s III‐IV ) , with a history of exacerbation in the previous year and at least one nonpulmonary comorbidity . Patients were r and omized to usual care ( n = 158 ) or telemonitoring ( n = 154 ) and followed for 9 months . All telemonitoring patients self‐assessed lung mechanics daily , and in a subgroup with congestive heart failure ( n = 37 ) cardiac parameters were also monitored . An algorithm identified deterioration , triggering a telephone contact to determine appropriate interventions . Measurements and Main Results : Primary outcomes were time to first hospitalization ( TTFH ) and change in the EuroQoL EQ‐5D utility index score . Secondary outcomes included : rate of antibiotic/corticosteroid prescription ; hospitalization ; the COPD Assessment Tool , Patient Health Question naire‐9 , and Minnesota Living with Heart Failure question naire scores ; quality ‐adjusted life years ; and healthcare costs . Telemonitoring did not affect TTFH , EQ‐5D utility index score , antibiotic prescriptions , hospitalization rate , or question naire scores . In an exploratory analysis , telemedicine was associated with fewer repeat hospitalizations ( −54 % ; P = 0.017 ) . Conclusions : In older patients with COPD and comorbidities , remote monitoring of lung function by forced oscillation technique and cardiac parameters did not change TTFH and EQ‐5D . Clinical trial registered with www . clinical trials.gov ( NCT 01960907 ) UNLABELLED SUBJECT OF THE EVIDENCE -BASED ANALYSIS : The purpose of this evidence based analysis report is to examine the safety and effectiveness of point-of-care ( POC ) international normalized ratio ( INR ) monitoring devices for patients on long-term oral anticoagulation therapy ( OAT ) .  CLINICAL NEED TARGET POPULATION AND CONDITION Long-term OAT is typically required by patients with mechanical heart valves , chronic atrial fibrillation , venous thromboembolism , myocardial infa rct ion , stroke , and /or peripheral arterial occlusion . It is estimated that approximately 1 % of the population receives anticoagulation treatment and , by applying this value to Ontario , there are an estimated 132,000 patients on OAT in the province , a figure that is expected to increase with the aging population . Patients on OAT  are regularly monitored and their medications adjusted to ensure that their INR scores remain in the therapeutic range . This can be challenging due to the narrow therapeutic window of warfarin and variation in individual responses . Optimal INR scores depend on the underlying indication for treatment and patient level characteristics , but for most patients the therapeutic range is an INR score of between 2.0 and 3.0 . The current st and ard of care in Ontario for patients on long-term OAT is laboratory-based INR determination with management carried out by primary care physicians or anticoagulation clinics ( ACCs ) . Patients also regularly visit a hospital or community-based facility to provide a venous blood sample s ( venipuncture ) that are then sent to a laboratory for INR analysis . Experts , however , have commented that there may be under-utilization of OAT due to patient factors , physician factors , or regional practice variations and that sub-optimal patient management may also occur . There is currently no population -based Ontario data to permit the assessment of patient care , but recent systematic review s have estimated that less that 50 % of patients receive OAT on a routine basis and that patients are in the therapeutic range only 64 % of the time . OVERVIEW OF POC INR DEVICES POC INR devices offer an alternative to laboratory-based testing and venipuncture , enabling INR determination from a fingerstick sample of whole blood . Independent evaluations have shown POC devices to have an acceptable level of precision . They permit INR results to be determined immediately , allowing for more rapid medication adjustments . POC devices can be used in a variety of setting s including physician offices , ACCs , long-term care facilities , pharmacies , or by the patients themselves through self-testing ( PST ) or self-management ( PSM ) techniques . With PST , patients measure their INR values and then contact their physician for instructions on dose adjustment , whereas with PSM , patients adjust the medication themselves based on pre-set algorithms . These models are not suitable for all patients and require the identification and education of suitable c and i date s. Potential advantages of POC devices include improved convenience to patients , better treatment compliance and satisfaction , more frequent monitoring and fewer thromboembolic and hemorrhagic complications . Potential disadvantages of the device include the tendency to underestimate high INR values and overestimate low INR values , low thromboplastin sensitivity , inability to calculate a mean normal PT , and errors in INR determination in patients with antiphospholipid antibodies with certain instruments . Although treatment satisfaction and quality of life ( QoL ) may improve with POC INR monitoring , some patients may experience increased anxiety or preoccupation with their disease with these strategies . EVIDENCE -BASED ANALYSIS METHODS RESEARCH QUESTIONS 1 . EffectivenessDoes POC INR monitoring improve clinical outcomes in various setting s compared to st and ard laboratory-based testing?Does POC INR monitoring impact patient satisfaction , QoL , compliance , acceptability , convenience compared to st and ard laboratory-based INR determination ? Setting s include primary care setting s with use of POC INR devices by general practitioners or nurses , ACCs , pharmacies , long-term care homes , and use by the patient either for PST or PSM . 2 . Cost-effectivenessWhat is the cost-effectiveness of POC INR monitoring devices in various setting s compared to st and ard laboratory-based INR determination ? INCLUSION CRITERIA English- language RCTs , systematic review s , and meta-analysesPUBLICATION DATE S : 1996 to November 25 , 2008 POPULATION : patients on OATINTERVENTION : anticoagulation monitoring by POC INR device in any setting including anticoagulation clinic , primary care ( general practitioner or nurse ) , pharmacy , long-term care facility , PST , PSM or any other POC INR strategy MINIMUM SAMPLE SIZE : 50 patients Minimum follow-up period : 3 monthsCOMPARATOR : usual care defined as venipuncture blood draw for an INR laboratory test and management provided by an ACC or individual practitioner OUTCOMES Hemorrhagic events , thromboembolic events , all-cause mortality , anticoagulation control as assessed by proportion of time or values in the therapeutic range , patient reported outcomes including satisfaction , QoL , compliance , acceptability , convenience EXCLUSION CRITERIA Non- RCTs , before-after studies , quasi-experimental studies , observational studies , case reports , case series , editorials , letters , non- systematic review s , conference proceedings , abstract s , non-English articles , duplicate publications Studies where POC INR devices were compared to laboratory testing to assess test accuracy Studies where the POC INR results were not used to guide patient management METHOD OF REVIEW A search of electronic data bases ( OVID MEDLINE , MEDLINE In-Process & Other Non-Indexed Citations , EMBASE , The Cochrane Library , and the International Agency for Health Technology Assessment [ INAHTA ] data base ) was undertaken to identify evidence published from January 1 , 1998 to November 25 , 2008 . Studies meeting the inclusion criteria were selected from the search results . Reference lists of selected articles were also checked for relevant studies . SUMMARY OF FINDINGS Five existing review s and 22 articles describing 17 unique RCTs met the inclusion criteria . Three RCTs examined POC INR monitoring devices with PST strategies , 11 RCTs examined PSM strategies , one RCT included both PST and PSM strategies and two RCTs examined the use of POC INR monitoring devices by health care professionals .  ANTICOAGULATION CONTROL Anticoagulation control is measured by the percentage of time INR is within the therapeutic range or by the percentage of INR values in the therapeutic range . Due to the differing method ologies and reporting structures used , it was deemed inappropriate to combine the data and estimate whether the difference between groups would be significant . Instead , the results of individual studies were weighted by the number of person-years of observation and then pooled to calculate a summary measure . Across most studies , patients in the intervention groups tended to have a higher percentage of time and values in the therapeutic target range in comparison to control patients . When the percentage of time in the therapeutic range was pooled across studies and weighted by the number of person-years of observation , the difference between the intervention and control groups was 4.2 % for PSM , 7.2 % for PST and 6.1 % for POC use by health care practitioners . Overall , intervention patients were in the target range 69 % of the time and control patients were in the therapeutic target range 64 % of the time leading to an overall difference between groups of roughly 5 % . MAJOR COMPLICATIONS AND DEATHS There was no statistically significant difference in the number of major hemorrhagic events between patients managed with POC INR monitoring devices and patients managed with st and ard laboratory testing ( OR = 0.74 ; 95 % CI : 0.52- 1.04 ) . This difference was non-significant for all POC strategies ( PSM , PST , health care practitioner ) . Patients managed with POC INR monitoring devices had significantly fewer thromboembolic events than usual care patients ( OR = 0.52 ; 95 % CI : 0.37 - 0.74 ) . When divided by POC strategy , PSM result ed in significantly fewer thromboembolic events than usual care ( OR = 0.46 . ; 95 % CI : 0.29 - 0.72 ) . The observed difference in thromboembolic events for PSM remained significant when the analysis was limited to major thromboembolic events ( OR = 0.40 ; 95 % CI : 0.17 - 0.93 ) , but was non-significant when the analysis was limited to minor thromboembolic events ( OR = 0.73 ; 95 % CI : 0.08 - 7.01 ) . PST and GP/Nurse strategies did not result in significant differences in thromboembolic events , however there were only a limited number of studies examining these interventions . No statistically significant difference was observed in the number of deaths between POC intervention and usual care control groups ( OR = 0.67 ; 95 % CI : 0.41 - 1.10 ) . This difference was non-significant for all POC strategies . Only one study reported on survival with 10-year survival rate of 76.1 % in the usual care control group compared to 84.5 % in the PSM group ( P=0.05 ) . ES Table 1 : Summary Results of Meta-Analyses of Major Complications and Deaths in POC INR Monitoring Studies EventNo . of trials ( patients ) OR(M-H , R and om Effects)95 % CIMajor Haemorrhages16 (5057)0.740.52 to 1.04Thromboembolic events16 (5057)0.520.37 to 0.74Deaths11 (2906)0.670.41 to 1.10 PATIENT SATISFACTION AND QUALITY OF LIFE : Quality of life measures were reported in eight studies comparing POC INR monitoring to st and ard laboratory testing using a variety of measurement tools . It was thus not possible to calculate a quantitative summary measure . The majority of studies reported favourable impacts of POC INR monitoring on QoL and found better treatment satisfaction with POC monitoring . Results from a pre- analysis patient and caregiver focus group conducted in Ontario also indicated improved patient QoL with POC monitoring . ( OBJECTIVE To assess the impact of supplementing nurse case management with Internet-connected telemonitoring on clinical outcomes in an elderly heart failure ( HF ) population . STUDY DESIGN R and omized clinical trial allocating high-risk HF subjects to the telehealth system with case management ( THCM ) versus case management ( CM ) alone . METHODS Medicare Advantage members with HF and recent hospitalization were r and omized to THCM or CM . Consenting participants received THCM for 6 months or the health plan 's usual Medicare specialized CM as long as deemed necessary . The primary outcome measure was a composite of all-cause hospitalization , ED visit , or death . Because only a subset of those who were r and omized consented and participated , the strategies were evaluated as-treated rather than by intention-to-treat , with multivariate adjustment in logistic regression models for confounding introduced by postr and omization exclusions . RESULTS The treated sample size was 164 subjects in THCM and 152 in CM . Treatment arms did not differ significantly for the primary composite outcome ( 45 % for THCM vs 40 % for CM , relative risk 1.18 ; P = .22 ) . Telehealth alerts prompted frequent telephonic contact , increasing THCM case managers ' workload . The participant population overall had 42 % fewer inpatient days during the intervention period compared with the previous year . CONCLUSIONS Despite effective implementation of an Internet-based telehealth intervention in an elderly HF population , there was no discernible impact on overall morbidity or mortality . Notably , limited postr and omization participation decreased power to detect a difference . The reduction in days hospitalized for trial participants overall underscores the benefit of CM for such HF patients The aim of this study was to investigate whether , in a r and omized controlled trial ( RCT ) of vulnerable elders with heart failure ( HF ) , advanced practice nurses ( APNs ) who were coordinating care in the transition from hospital to home could improve outcomes , prevent rehospitalizations , and reduce costs when compared with usual care . The APN strategies focused on improving patient and family or caregiver effectiveness in managing their illnesses , strengthening the patient-provider relationship , and managing comorbid conditions while improving overall health . The results were positive . By capitalizing on the patient 's desire to achieve their identified goals , APNs successfully educated patients about the meaning of their symptoms and appropriate self-management strategies ; improved patient-provider communication patterns ; and marshaled caregiver and community re sources to maximize patient adherence to the treatment plan and overall quality of life . While HF was the primary reason for enrollment in the study , optimal health outcomes dem and ed a strong focus on integrating management of comorbid conditions and other long-st and ing health problems . Specific strategies used by the APN to achieve these positive outcomes are addressed in this report . These strategies are compared with nursing interventions used in other RCTs of HF home management . Directions for future research are explored OBJECTIVES The primary objective was to determine if wireless remote monitoring with automatic clinician alerts reduces the time from a clinical event to a clinical decision in response to arrhythmias , cardiovascular ( CV ) disease progression , and device issues compared to patients receiving st and ard in-office care . A secondary objective was to compare the rates of CV health care utilization between patients in the remote and in-office arms . BACKGROUND In addition to providing life-saving therapy , implantable cardioverter-defibrillators collect advanced diagnostics on the progression of the patient 's heart disease . Device technology has progressed to allow wireless remote monitoring with automatic clinician alerts to replace some scheduled in-office visits . METHODS The CONNECT ( Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision ) study was a multicenter , prospect i ve , r and omized evaluation involving 1,997 patients from 136 clinical sites who underwent insertion of an implantable cardioverter-defibrillator ( including cardiac resynchronization therapy devices ) and were followed up for 15 months . Health care utilization data included all CV-related hospitalizations , emergency department visits , and clinic office visits . RESULTS The median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm ( p < 0.001 ) . The health care utilization data revealed a decrease in mean length of stay per CV hospitalization visit from 4.0 days in the in-office arm to 3.3 days in the remote arm ( p = 0.002 ) . CONCLUSIONS Wireless remote monitoring with automatic clinician alerts as compared with st and ard in-office follow-up significantly reduced the time to a clinical decision in response to clinical events and was associated with a significant reduction in mean length of CV hospital stay . ( Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision [ CONNECT ] ; NCT00402246 ) Background Mobile health ( mHealth ) interventions may improve heart failure ( HF ) self-care , but st and ard models do not address informal caregivers ’ needs for information about the patient ’s status or how the caregiver can help . Objective We evaluated mHealth support for caregivers of HF patients over and above the impact of a st and ard mHealth approach . Methods We identified 331 HF patients from Department of Veterans Affairs outpatient clinics . All patients identified a “ CarePartner ” outside their household . Patients r and omized to “ st and ard mHealth ” ( n=165 ) received 12 months of weekly interactive voice response ( IVR ) calls including questions about their health and self-management . Based on patients ’ responses , they received tailored self-management advice , and their clinical team received structured fax alerts regarding serious health concerns . Patients r and omized to “ mHealth+CP ” ( n=166 ) received an identical intervention , but with automated emails sent to their CarePartner after each IVR call , including feedback about the patient ’s status and suggestions for how the CarePartner could support disease care . Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate . Self-care and symptom data also were collected through the weekly IVR assessment s. Results Participants were on average 67.8 years of age , 99 % were male ( 329/331 ) , 77 % where white ( 255/331 ) , and 59 % were married ( 195/331 ) . During 15,709 call-weeks of attempted IVR assessment s , patients completed 90 % of their calls with no difference in completion rates between arms . At both endpoints , composite quality of life scores were similar across arms . However , more mHealth+CP patients reported taking medications as prescribed at 6 months ( 8.8 % more , 95 % CI 1.2 - 16.5 , P=.02 ) and 12 months ( 13.8 % more , CI 3.7 - 23.8 , P<.01 ) , and 10.2 % more mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up ( P=.048 ) . mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints ( both P<.05 ) , were consistently more likely to report taking medications as prescribed during weekly IVR assessment s , and also were less likely to report breathing problems or weight gains ( all P<.05 ) . Among patients with more depressive symptoms at enrollment , those r and omized to mHealth+CP were more likely than st and ard mHealth patients to report excellent or very good general health during weekly IVR calls . Conclusions Compared to a relatively intensive model of IVR monitoring , self-management assistance , and clinician alerts , a model including automated feedback to an informal caregiver outside the household improved HF patients ’ medication adherence and caregiver communication . mHealth+CP may also decrease patients ’ risk of HF exacerbations related to shortness of breath and sudden weight gains .  mHealth+CP may improve quality of life among patients with greater depressive symptoms . Weekly health and self-care monitoring via mHealth tools may identify intervention effects in mHealth trials that go undetected using typical , infrequent retrospective surveys . Trial Registration Clinical Trials.gov NCT00555360 ; https:// clinical trials.gov/ct2/show/NCT00555360 ( Archived by WebCite at http://www.webcitation.org/6Z4Tsk78B ) Previous studies have found that home-based intervention programs reduce readmission rates for patients with heart failure . Only one previous trial has compared telephone and videophone to traditional care to deliver a home-based heart failure intervention program . The objective of this study was to evaluate the efficacy of a telehealth-facilitated postdischarge support program in reducing re source use in patients with heart failure . Patients at a Midwestern Department of Veterans Affairs Medical Center were r and omized to telephone , videophone , or usual care for follow-up care after hospitalization for heart failure exacerbation . Outcome measures included readmission rates ; time to first readmission ; urgent care clinic visits ; survival ; and quality of life . The intervention result ed in a significantly longer time to readmission but had no effect on readmission rates or mortality . There were no differences in hospital days or urgent care clinic use . All subjects reported higher disease-specific quality of life scores at 1 year . There was evidence of the value of telephone follow-up , but there was no evidence to support the benefit of videophone care over telephone care . Rigorous evaluation is needed to determine which patients may benefit most from specific telehealth applications and which technologies are most cost-effective OBJECTIVES The purpose of this study was to evaluate remote pacemaker interrogation for the earlier diagnosis of clinical ly actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation . BACKGROUND Pacemaker patient follow-up procedures have evolved from evaluating devices with little programmability and diagnostic information solely in person to transtelephonic rhythm strip recordings that allow monitoring of basic device function . More recently developed remote monitoring technology leverages exp and ed device capabilities , augmenting traditional transtelephonic monitoring to evaluate patients via full device interrogation . METHODS The time to first diagnosis of a clinical ly actionable event was compared in patients who were followed by remote interrogation ( Remote )  and those who were followed per st and ard of care with office visits augmented by transtelephonic monitoring ( Control ) . Patients were r and omized 2:1 . Remote arm  patients transmitted pacemaker information at 3-month intervals .  Control arm patients with a single-chamber pacemaker transmitted at 2-month intervals . Control arm patients with dual-chamber devices transmitted at 2-month intervals with an office visit at 6 months . All patients were seen in office at 12 months . RESULTS The mean time to first diagnosis of clinical ly actionable events was earlier in the Remote arm ( 5.7 months ) than in the Control arm ( 7.7 months ) . Three ( 2 % ) of the 190 events in the Control arm and 446 ( 66 % ) of 676 events in the Remote arm were identified remotely . CONCLUSIONS The strategic use of remote pacemaker interrogation follow-up detects actionable events that are potentially important more quickly and more frequently than transtelephonic rhythm strip recordings . The use of transtelephonic rhythm strips for pacemaker follow-up is of little value except for battery status determinations . ( PREFER [ Pacemaker Remote Follow-up Evaluation and Review ] ; NCT00294645 ) Introduction The Rehabilitation EnAblement in CHronic Heart Failure ( REACH-HF ) trial is part of a research programme design ed to develop and evaluate a health professional facilitated , home-based , self-help rehabilitation intervention to improve self-care and health-related quality of life in people with heart failure and their caregivers . The trial will assess the clinical effectiveness and cost-effectiveness of the REACH-HF intervention in patients with systolic heart failure and impact on the outcomes of their caregivers . Methods and analysis A parallel two group r and omised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care ( intervention group ) or usual care alone ( control group ) in 216 patients with systolic heart failure ( ejection fraction < 45 % ) and their caregivers . The intervention comprises a self-help manual delivered by specially trained facilitators over a 12-week period . The primary outcome measure is patients ’ disease-specific health-related quality of life measured using the Minnesota Living with Heart Failure question naire at 12 months ’ follow-up . Secondary outcomes include survival and heart failure related hospitalisation , blood biomarkers , psychological well-being , exercise capacity , physical activity , other measures of quality of life , patient safety and the quality of life , psychological well-being and perceived burden of caregivers at 4 , 6 and 12 months ’ follow-up . A process evaluation will assess fidelity of intervention delivery and explore potential mediators and moderators of changes in health-related quality of life in intervention and control group patients . Qualitative studies will describe patient and caregiver experiences of the intervention . An economic evaluation will estimate the cost-effectiveness of the REACH-HF intervention plus usual care versus usual care alone in patients with systolic heart failure . Ethics and dissemination The study is approved by the North West — Lancaster Research Ethics Committee ( ref 14/NW/1351 ) . Findings will be disseminated via journals and presentations to publicise the research to clinicians , commissioners and service users . Trial registration number IS RCT N86234930 ; Pre- results Abstract Background Most depressed patients are attended at primary care . However , there are significant shortcomings in the diagnosis , management and outcomes of these patients . The aim of this study is to determine whether the implementation of a structured programme for managing depression will provide better health outcomes than usual management . Methods / Design Design : A cluster-r and omized controlled trial involving two groups , one of which is the  control group consisting of patients who are treated for depression in the usual way and the other is the  intervention group consisting of patients on a structured programme for treating depression . Setting : 20 primary care centres in the province of Tarragona ( Spain ) Sample : 400 patients over 18 years of age who have experienced an episode of major depression ( DSM-IV ) and who need to initiate antidepressant treatment Intervention : A multi-component programme with clinical , educational and organisational procedures that includes training for the health care provider and evidence -based clinical guidelines . It also includes primary care nurses working as care-managers who provide educational and emotional support for the patients and who are responsible for active and systematic clinical monitoring . The programme aims to improve the primary care/specialized level interface . Measurements : The patients will be monitored by telephone interviews . The interviewer will not know which group the patient belongs to ( blind trial ) . These interviews will be given at 0 , 3 , 6 and 12 months . Main variables : Severity of the depressive symptoms , response rate and remission rate . Analysis : Outcomes will be analyzed on an intent-to-treat basis and the unit of analysis will be the individual patient . This analysis will take into account the effect of study design on potential lack of independence between observations within the same cluster . Discussion The effectiveness of caring for depression in primary care can be improved by various strategies . The most effective models involve organisational changes and a greater role of nurses . However , these models are almost exclusively from the USA , and this r and omized clinical trial will determine if this approach could be effective to improve the outcomes of depression in primary care in the Spanish health care system . Trial registration IS RCT OBJECTIVES This study sought to measure the impact on all-cause death or readmission of adding center-based exercise training ( ET ) to disease management programs for patients with a recent acute heart failure ( HF ) hospitalization . BACKGROUND ET is recommended for patients with HF , but evidence is based mainly on ET as a single intervention in stable out patients . METHODS A r and omized , controlled trial with blinded outcome assessor , enrolling adult participants with HF discharged from 5 hospitals in Queensl and , Australia . All participants received HF-disease management program plus supported home exercise program ; intervention participants were offered 24 weeks of supervised center-based ET . Primary outcome was all-cause 12-month death or readmission . Pre-planned subgroups included age ( < 70 years vs. older ) , sex , left ventricular ejection fraction ( ≤40 % vs. > 40 % ) , and exercise adherence . RESULTS Between May 2008 and July 2013 , 278 participants ( 140 intervention , 138 control ) were enrolled : 98 ( 35.3 % ) age ≥70 years , 71 ( 25.5 % ) females , and 62 ( 23.3 % ) with a left ventricular ejection fraction of > 40 % . There were no adverse events associated with ET . There was no difference in primary outcome between groups ( 84 of 140 [ 60.0 % ] intervention vs. 90 of 138 [ 65.2 % ] control ; p = 0.37 ) , but a trend toward greater benefit in participants age < 70 years ( OR : 0.56 [ 95 % CI : 0.30 to 1.02 ] vs. OR : 1.56 [ 95 % CI : 0.67 to 3.64 ] ; p for interaction = 0.05 ) . Participants who exercised to guidelines ( 72 of 101 control and 92 of 117 intervention at 3 months ) had a significantly lower rate of death and readmission ( 91 of 164 [ 55.5 % ] vs. 41 of 54 [ 75.9 % ] ; p = 0.008 ) . CONCLUSIONS Supervised center-based ET was a safe , feasible addition to disease management programs with supported home exercise in patients recently hospitalized with acute HF , but did not reduce combined end-point of death or readmission . ( A supervised exercise programme following hospitalisation for heart failure : does it add to disease management ? ; ACTRN12608000263392 ) BACKGROUND Although the potential to reduce hospitalisation and mortality in chronic heart failure ( CHF ) is well reported , the feasibility of receiving healthcare by structured telephone support or telemonitoring is not . AIMS To determine ; adherence , adaptation and acceptability to a national nurse-coordinated telephone-monitoring CHF management strategy . The Chronic Heart Failure Assistance by Telephone Study ( CHAT ) . METHODS Triangulation of descriptive statistics , feedback surveys and qualitative analysis of clinical notes . Cohort comprised of st and ard care plus intervention ( SC+I ) participants who completed the first year of the study . RESULTS 30 GPs ( 70 % rural ) r and omised to SC+I recruited 79 eligible participants , of whom 60 ( 76 % ) completed the full 12 month follow-up period . During this time 3619 calls were made into the CHAT system ( mean 45.81 SD+/-79.26 , range 0 - 369 ) , Overall there was an adherence to the study protocol of 65.8 % ( 95 % CI 0.54 - 0.75 ; p=0.001 ) however , of the 60 participants who completed the 12 month follow-up period the adherence was significantly higher at 92.3 % ( 95 % CI 0.82 - 0.97 , p < or=0.001 ) . Only 3 % of this elderly group ( mean age 74.7+/-9.3 years ) were unable to learn or competently use the technology . Participants rated CHAT with a total acceptability rate of 76.45 % . CONCLUSION This study shows that elderly CHF patients can adapt quickly , find telephone-monitoring an acceptable part of their healthcare routine , and are able to maintain good adherence for a least 12 months Objectives To compare the costs and cost-effectiveness of managing patients with uncontrolled blood pressure ( BP ) using telemonitoring versus usual care from the perspective of the National Health Service ( NHS ) . Design Within trial post hoc economic evaluation of data from a pragmatic r and omised controlled trial using an intention-to-treat approach . Setting 20 socioeconomically diverse general practice s in Lothian , Scotl and . Participants 401 primary care patients aged 29–95 with uncontrolled daytime ambulatory blood pressure ( ABP ) ( ≥135/85 , but < 210/135 mm Hg ) . Intervention Participants were central ly r and omised to 6 months of a telemonitoring service comprising of self-monitoring of BP transmitted to a secure website for review by the attending nurse/doctor and patient , with optional automated patient decision-support by text/email ( n=200 ) or usual care ( n-201 ) . R and omisation was undertaken with minimisation for age , sex , family practice , use of three or more hypertension drugs and self-monitoring history . Main outcome measures Mean difference in total NHS costs between trial arms and blinded assessment of mean cost per 1 mm Hg systolic BP point reduced .  Results Home telemonitoring of BP costs significantly more than usual care ( mean difference per patient £ 115.32 ( 95 % CI £ 83.49 to £ 146.63 ; p<0.001 ) ) . Increased costs were due to telemonitoring service costs , patient training and additional general practitioner and nurse consultations . The mean cost of systolic BP reduction was £ 25.56/mm Hg ( 95 % CI £ 16.06 to £ 46.89 ) per patient . Conclusions Over the 6-month trial period , supported telemonitoring was more effective at reducing BP than usual care but also more expensive . If clinical gains are maintained , these additional costs would be very likely to be compensated for by reductions in the cost of future cardiovascular events . Longer-term modelling of costs and outcomes is required to fully examine the cost-effectiveness implication s. Trial registration International St and ard R and omised Controlled Trials , number IS RCT N72614272 Background — Secondary prevention by risk factor modification improves patient outcomes , yet it is often not achieved in clinical practice . Reasons for failure stem from challenges of prioritizing risk factor reduction and engaging patients in changing their behaviors . We hypothesize that a novel telemedicine intervention with tailored patient education could improve cardiovascular risk factors . Methods — To evaluate this intervention , we propose enrolling 450 patients with a recent myocardial infa rct ion and hypertension into a 3-arm r and omized , controlled trial . The first arm ( n=150 ) will receive home blood pressure ( BP ) monitors plus a nurse-delivered , telephone-based tailored patient education intervention and will be enrolled into HealthVault , a Microsoft electronic health record platform . The second arm ( n=150 ) will also receive BP monitors plus a tailored patient education intervention and be enrolled in HeartVault . However , the patient education intervention will be delivered by a Web-based program and will cover topics identical to those in the nurse-delivered intervention . Both arms will be compared with a control group receiving st and ard care ( n=150 ) . All participants will have an in-person assessment at baseline and at completion of the study , including st and ardized measurements of BP , LDL cholesterol , and glycosylated hemoglobin ( in diabetic subjects ) . The study design will allow assessment of a telephone-based , nurse-administered disease management program versus st and ard care . The main outcome of interest is the reduction in systolic BP in each intervention group compared with the control group at 12 months . Secondary outcomes assessed will include reductions in LDL cholesterol , body weight , and glycosylated hemoglobin , as well as adherence to evidence -based therapies and improvement in health behaviors . Conclusion — If successful in optimizing BP control , managing other coronary heart disease risk factors , and demonstrating a lower cost , the Web-based disease management tool has the potential to enhance coronary artery disease management , quality of care , and ultimately , patient outcomes . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00901277 BACKGROUND We performed a prospect i ve , r and omized investigation assessing the incremental effect of automated health monitoring ( AHM ) technology over and above that of a previously described nurse directed heart failure ( HF ) disease management program . The AHM system measured and transmitted body weight , blood pressure , and heart rate data as well as subjective patient self- assessment s via a st and ard telephone line to a central server . METHODS AND RESULTS A total of 188 consented and eligible patients were r and omized between intervention and control groups in 1:1 ratio . Subjects r and omized to the control arm received the Specialized Primary and Networked Care in Heart Failure ( SPAN-CHF ) heart failure disease management program . Subjects r and omized to the intervention arm received the SPAN-CHF disease management program in conjunction with the AHM system . The primary end point was prespecified as the relative event rate of HF hospitalization between intervention and control groups at 90 days . The relative event rate of HF hospitalization for the intervention group compared with controls was 0.50 ( 95%CI [ 0.25 - 0.99 ] , P = .05 ) . CONCLUSIONS Short-term reductions in the heart failure hospitalization rate were associated with the use of automated home monitoring equipment . Long-term benefits in this model remain to be studied Background Outpatient chemotherapy is a core treatment for haematological malignancies ; however , its toxicities frequently lead to distressing/potentially life-threatening side-effects ( neutropenia/infection , nausea/vomiting , mucositis , constipation/diarrhoea , fatigue ) . Early detection/management of side-effects is vital to improve patient outcomes , decrease morbidity and limit lengthy/costly hospital admissions . The ability to capture patient-reported health data in real-time , is regarded as the ‘ gold-st and ard ’ to allow rapid clinical decision-making/intervention . This paper presents the protocol for a Phase 3 multi-site r and omised controlled trial evaluating a novel nurse-led Telehealth intervention for remote monitoring/management of chemotherapy side-effects in Australian haematological cancer patients . Methods / Design Two hundred and twenty-two patients will be recruited from two hospitals . Eligibility criteria include : diagnosis of chronic lymphocytic leukaemia/Hodgkin’s/non-Hodgkin ’s lymphoma ; aged ≥ 18 years ; receiving ≥ 2 cycles chemotherapy . Patients will be r and omised 1:1 to either the control or intervention arm with stratification by diagnosis , chemotherapy toxicity ( high versus low ) , receipt of previous chemotherapy and hospital . Patients allocated to the control arm will receive ‘ Usual Care ’ whilst those allocated to the intervention will receive the intervention in addition to ‘ Usual Care ’ . Intervention patients will be provided with a computer tablet and software prompting twice-daily completion of physical/emotional scales for up to four chemotherapy cycles . Should patient data exceed pre-determined limits an Email alert is delivered to the treatment team , prompting nurses to view patient data , and contact the patient to provide clinical intervention . In addition , six scheduled nursing interventions will be completed to educate/support patients in use of the software . Patient outcomes will be measured cyclically ( midpoint and end of cycles ) via pen- and -paper self-report alongside review of the patient medical record . The primary outcome is burden due to nausea , mucositis , constipation and fatigue . Secondary outcomes include : burden due to vomiting and diarrhoea ; psychological distress ; ability to self-manage health ; level of cancer information/support needs and ; utilisation of health services . Analyses will be intention-to-treat . A cost-effectiveness analysis is planned . Discussion This trial is the first in the world to test a remote monitoring/management intervention for adult haematological cancer patients receiving chemotherapy . Future use of such interventions have the potential to improve patient outcomes /safety and decrease health care costs by enabling early detection/ clinical intervention . Trial registration ACTRN12614000516684 . Date registered : 12 March 2014 ( registered retrospectively ) Introduction The Rehabilitation EnAblement in CHronic Heart Failure in patients with Heart Failure ( HF ) with preserved ejection fraction ( REACH-HFpEF ) pilot trial is part of a research programme design ed to develop and evaluate a facilitated , home-based , self-help rehabilitation intervention to improve self-care and quality of life ( QoL ) in heart failure patients and their caregivers . We will assess the feasibility of a definitive trial of the REACH-HF intervention in patients with HFpEF and their caregivers . The impact of the REACH-HF intervention on echocardiographic outcomes and bloodborne biomarkers will also be assessed . Methods and analysis A single-centre parallel two-group r and omised controlled trial ( RCT ) with 1:1 individual allocation to the REACH-HF intervention plus usual care ( intervention ) or usual care alone ( control ) in 50 HFpEF patients and their caregivers . The REACH-HF intervention comprises a REACH-HF manual with supplementary tools , delivered by trained facilitators over 12 weeks . A mixed methods approach will be used to assess estimation of recruitment and retention rates ; fidelity of REACH-HF manual delivery ; identification of barriers to participation and adherence to the intervention and study protocol ; feasibility of data collection and outcome burden . We will assess the variance in study outcomes to inform a definitive study sample size and assess methods for the collection of re source use and intervention delivery cost data to develop the cost-effectiveness analyses framework for any future trial . Patient outcomes collected at baseline , 4 and 6 months include QoL , psychological well-being , exercise capacity , physical activity and HF-related hospitalisation . Caregiver outcomes will also be assessed , and a sub study will evaluate impact of the REACH-HF manual on resting global cardiovascular function and bloodborne biomarkers in HFpEF patients . Ethics and dissemination The study is approved by the East of Scotl and Research Ethics Service ( Ref : 15/ES/0036 ) . Findings will be disseminated via journals and presentations to clinicians , commissioners and service users . Trial registration number IS RCT N78539530 ; Pre- results Background Chronic heart failure ( HF ) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes . The Patient Centered Disease Management ( PCDM ) trial was design ed to test the effectiveness of collaborative care disease management in improving health status ( symptoms , functioning , and quality of life ) in patients with HF who reported poor HF-specific health status . Methods / design Patients with a HF diagnosis at four VA Medical Centers were identified through population -based sampling . Patients with a Kansas City Cardiomyopathy Question naire ( KCCQ , a measure of HF-specific health status ) score of < 60 ( heavy symptom burden and impaired quality of life ) were invited to enroll in the PCDM trial . Enrolled patients were r and omized to receive usual care or the PCDM intervention , which included : ( 1 ) collaborative care management by VA clinicians including a nurse , cardiologist , internist , and psychiatrist , who worked with patients and their primary care providers to provide guideline -concordant care management , ( 2 ) home telemonitoring and guided patient self-management support , and ( 3 ) screening and treatment for comorbid depression . The primary study outcome is change in overall KCCQ score . Secondary outcomes include depression , medication adherence , guideline -based care , hospitalizations , and mortality . Discussion The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status , implementing a collaborative care model of health care delivery , and addressing depression , a key barrier to optimal disease management . The study has been design ed as an ‘ effectiveness trial ’ to support broader implementation in the healthcare system if it is successful . Trial registration Unique identifier : AIMS The Exercise Joins Education : Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure ( EJECTION-HF ) study will evaluate the impact of a supervised exercise training programme ( ETP ) on clinical outcomes in recently hospitalized heart failure patients attending a disease management programme ( DMP ) . Methods This multisite , pragmatic r and omized controlled trial enrols patients discharged from participating hospitals with clinical evidence of heart failure who are willing and able to participate in a DMP and considered clinical ly safe to exercise . Enrolment includes participants with impaired and preserved left ventricular systolic function . Baseline assessment and programme commencement occur within 6 weeks of hospital discharge . The control group DMP includes individualized education and follow-up from a multidisciplinary heart failure team ; a weekly education programme for 12 weeks ; self-management advice ; and medical follow-up . Home exercise is recommended for all participants . In addition , intervention participants are offered 36 supervised , structured gym-based 1 h exercise sessions over 24 weeks . Sessions are tailored to exercise capacity and include aerobic , resistance , and balance exercises . Enrolment target is 350 participants . Primary outcome is 12-month mortality and readmissions . Secondary outcomes include blinded evaluation of depressive symptoms , sleep quality , cognition , and functional status ( activities of daily living , 6 min walk distance , grip strength ) at 3 and 6 months . A cost-utility analysis will be conducted . CONCLUSION This study will enrol a representative group of hospitalized heart failure patients and measure a range of patient and health service outcomes to inform the design of post-hospital DMPs for heart failure . Enrolment will be completed in 2013 . ACTRN12608000263392 Context Patients sometimes have difficulty following complicated treatment regimens . Contribution In this trial , 314 low-income patients with congestive heart failure were r and omly assigned to a pharmacist intervention or usual care . The pharmacist assessed patient knowledge and provided instructions about medication use . During the 9-month intervention , patients in the intervention group had greater medication adherence than patients in the usual care group ( 79 % vs. 68 % ) . These differences dissipated within 3 months of stopping the intervention . Patients in the intervention group also had fewer exacerbations result ing in emergency department visits or hospitalizations than patients in the usual care group . Implication Ongoing educational intervention by a pharmacist can improve medication adherence and outcomes in patients with heart failure . The Editors In the United States , 5 million people have heart failure , with total health care costs exceeding $ 29 billion ( 1 ) . These costs are largely derived from expensive exacerbations that require emergency visits and hospitalizations ( 1 , 2 ) . Regularly administered cardiovascular medications may preserve cardiac function , improve quality of life , and reduce risk for costly exacerbations . However , patients sometimes do not adhere to prescribed instructions and have poor outcomes ( 35 ) . Research ers have estimated that approximately 50 % of patients with chronic illnesses do not take their medications as prescribed ( 6 ) . Reasons for nonadherence include lack of patient knowledge , skills , and support to appropriately self-manage complicated medication regimens ( 7 , 8) . Although chronic disease management programs abound , few studies have rigorously tested interventions aim ed at improving patient adherence to prescribed medications and their effect on health outcomes ( 9 , 10 ) . We conducted a r and omized clinical trial to assess the effect of a pharmacist intervention on patients who are socioeconomically disadvantaged and medically vulnerable . We hypothesized that the intervention would improve adherence to heart failure medications , reduce exacerbations requiring emergency department visits or hospitalization , improve disease-specific quality of life , increase patient satisfaction , and reduce health care costs . Methods Design Overview The methods for our r and omized trial are described elsewhere ( 1113 ) . We recruited patients from the general medicine and cardiology practice s of Wishard Health Services , Indianapolis , Indiana , which serves socioeconomically disadvantaged and medically vulnerable patients . The study was conducted from February 2001 to June 2004 . Patients took part in the study for 12 months and received 9 months of active intervention by the pharmacist or usual care followed by 3 months of postintervention assessment . Patients in the usual care and intervention groups visited the same pharmacy location , but the intervention pharmacist was instructed to have no contact with patients in the usual care group . The institutional review boards of Indiana UniversityPurdue University and the University of North Carolina at Chapel Hill approved this study . Setting and Patients Indiana University Medical Group , Indianapolis , is an academic primary care group practice composed of primary and specialty care clinics affiliated with Wishard Health Services . Faculty physicians , residents , and nurse practitioners provide care to 13000 adults ( mean age , 57 years [ SD , 15 ] ; 60 % women ; 50 % African American ) . Annually , these patients make approximately 50000 visits to practice s , 72000 visits to emergency departments , and 135000 visits to pharmacies and have 16000 hospitalizations . We recruited patients from 4 identical general medicine practice s , 1 cardiology practice , and Wishard Memorial Hospital . Practice s met in half-day sessions per week that were attended by 2 or 3 faculty members and 3 to 5 residents or fellows from each practice . Faculty physicians practice d 1 to 5 half-days per week , whereas fellows practice d 1 to 2 half-days per week and residents attended the practice 1 half-day per week . Out patients of Wishard Health Services fill their prescriptions at central or de central ized outpatient pharmacies located at the ambulatory care center or at 1 of several satellite pharmacies stationed at neighborhood clinics . Fully stocked de central ized pharmacies serviced all study patients . From February 2001 to January 2003 , the study pharmacy was located in a building adjacent to the ambulatory care center . From February 2003 to June 2004 , the study pharmacy was moved to a space adjacent to the general medicine practice s in the ambulatory care center . Two pharmacists and 1 technician were stationed at the pharmacy . The study pharmacist was instructed to service patients in the intervention group only , and a second pharmacist serviced patients in the usual care group and filled prescriptions to be delivered to patients at outlying clinics . The technician filled prescriptions and read electronic adherence monitors . Weekly lists of eligible patients were created by using the Regenstrief Medical Record System ( Regenstrief Institute , Indianapolis , Indiana ) ( 14 , 15 ) . We invited clinical ly stable patients from general internal medicine practice s , a cardiology clinic , and Wishard Memorial Hospital ( at discharge ) to participate in the study . Of 3034 patients with a diagnosis of heart failure , 1512 met criteria for enrollment . Patients were eligible if they were 50 years of age or older ; planned to receive all of their care , including prescribed medications , at Wishard Health Services ; had a diagnosis of heart failure confirmed by their primary care physician ; regularly used at least 1 cardiovascular medication for heart failure ( angiotensin-converting enzyme [ ACE ] inhibitor or angiotensin-receptor blocker , -adrenergic antagonist , diuretic , digoxin , or aldosterone antagonist ) ; were not using or were not planning to use a medication container adherence aid ( for example , a pill box ) ; had access to a working telephone ; and could hear within the range of normal conversation . We excluded patients with dementia . Patients received their prescription medications through state and local assistance plans at no cost . Thus , cost of medicines was not a deterrent to adherence . R and omization A trained interviewer conducted a baseline interview at enrollment . Interviewers were blinded to patients ' study status and played no role in the delivery of the intervention . Interviewers contacted a central ized data manager at the end of each interview to determine the patient 's study assignment , which was otherwise concealed . We r and omly assigned patients , without blocking or stratification , to receive the pharmacy intervention or usual care by using a univariate discrete distribution from the IMSL Fortran Library 's subroutine RNGDA pseudor and om number generator ( Absoft Corp. , Rochester Hills , Michigan ) ( 16 ) . We r and omly assigned more patients to the usual care group so that this group could also be a prospect i ve cohort for study ing risk factors associated with the clinical deterioration of heart failure . Of the 314 patients included in the study , 229 were recruited from the general internal medicine practice s , 15 from the cardiology clinic , and 70 on discharge from the Wishard Memorial Hospital . The numbers of patients assigned to the intervention and usual care groups did not differ by recruitment site ( P= 0.83 ) . Intervention A pharmacist delivered the intervention by using a protocol ( Appendix Table 1 ) that included a baseline medication history of all prescription and over-the-counter drugs and dietary supplements taken by patients , which patients brought with them to the baseline interview , and the results of an assessment of patient medication knowledge and skills ( 7 , 8) . The pharmacist dispensed enough of the patient 's medications to last approximately 2 months . Appendix Table 1 . Pharmacist 's Intervention Protocol * When medications were dispensed , the pharmacist provided patient-centered verbal instructions and written material s about the medications ( 11 , 13 , 17 ) by using a schema for instruction that has been tested ( 18 , 19 ) . We assigned each medication category an icon ( for example , the icon for ACE inhibitors was a red ace of hearts ) . The same icon appeared on the container label and lid and on the written patient instructions . Written instructions were aim ed at patients with low health literacy and contained an easy-to-follow timeline to remind patients when to take their medications ( 13 ) . The pharmacist monitored patients ' medication use , health care encounters , body weight , and other relevant data by using a study data base ( 20 , 21 ) . Information about patients was communicated as needed to clinic nurses and primary care physicians by face-to-face visits , telephone , paging ( physician only ) , and e-mail ( physician only ) . Technicians supported the pharmacist 's dispensing efforts within the pharmacy throughout the study . We incorporated costs therein into the economic analysis . Pharmacists serviced patients in the usual care group who were not associated with the intervention or the study . An interdisciplinary team of investigators that included pharmacists with advanced training in patient education and cardiovascular pharmacotherapy , a geriatrician , a cardiologist with expertise in heart failure , a behavioral scientist , and a cognitive psychologist trained the intervention pharmacist . The intervention pharmacist also studied guidelines for treating heart failure ( 22 ) , key concepts in the pharmaceutical care of older adults , communication techniques , and the pharmacotherapy of the cardiovascular drugs for heart failure . All pharmacists at Wishard Health Services were aware of the study and were instructed on how to h and le and redirect intervention patients who inadvertently arrived at their pharmacy . Usual Care Patients in the usual care group were aware of the purpose of the study , and their primary care Background Intensive remote monitoring programs for congestive heart failure have been successful in reducing costly readmissions , but may not be appropriate for all patients . There is an opportunity to leverage the increasing accessibility of mobile technologies and consumer-facing digital devices to empower patients in monitoring their own health outside of the hospital setting . The iGetBetter system , a secure Web- and telephone-based heart failure remote monitoring program , which leverages mobile technology and portable digital devices , offers a creative solution at lower cost . Objective The objective of this pilot study was to evaluate the feasibility of using the iGetBetter system for disease self-management in patients with heart failure . Methods This was a single-arm prospect i ve study in which 21 ambulatory , adult heart failure patients used the  intervention for heart failure self-management over a 90-day study period . Patients were instructed to take their weight , blood pressure , and heart rate measurements each morning using a WS-30 bluetooth weight scale , a self-inflating blood pressure cuff ( Withings LLC , Issy les Moulineaux , France ) , and an iPad Mini tablet computer ( Apple Inc , Cupertino , CA , USA ) equipped with cellular Internet connectivity to view their measurements on the Internet . Outcomes assessed included usability and satisfaction , engagement with the intervention , hospital re source utilization , and heart failure-related quality of life . Descriptive statistics were used to summarize data , and matched controls identified from the electronic medical record were used as comparison for evaluating hospitalizations . Results There were 20 participants ( mean age 53 years ) that completed the study . Almost all participants ( 19/20 , 95 % ) reported feeling more connected to their health care team and more confident in performing care plan activities , and 18/20 ( 90 % ) felt better prepared to start discussion s about their health with their doctor . Although heart failure-related quality of life improved from baseline , it was not statistically significant ( P=.55 ) . Over half of the participants had greater than 80 % ( 72/90 days ) weekly and overall engagement with the program , and 15 % ( 3/20 ) used the interactive voice response telephone system exclusively for managing their care plan . Hospital utilization did not differ in the intervention group compared to the control group ( planned hospitalizations P=.23 , and unplanned hospitalizations P=.99 ) . Intervention participants recorded shorter average length of hospital stay , but no significant differences were observed between intervention and control groups ( P=.30 ) . Conclusions This pilot study demonstrated the feasibility of a low-intensive remote monitoring program leveraging commonly used mobile and portable consumer devices in augmenting care for a fairly young population of ambulatory patients with heart failure . Further prospect i ve studies with a larger sample size and within more diverse patient population s is necessary to determine the effect of mobile-based remote monitoring programs such as the iGetBetter system on clinical outcomes in heart failure Background Hospitals are st and ard of care for acute illness , but hospitals can be unsafe , uncomfortable , and expensive . Providing substitutive hospital-level care in a patient ’s home potentially reduces cost while maintaining or improving quality , safety , and patient experience , although evidence from r and omized controlled trials in the US is lacking . Objective Determine if home hospital care reduces cost while maintaining quality , safety , and patient experience . Design R and omized controlled trial . Participants Adults admitted via the emergency department with any infection or exacerbation of heart failure , chronic obstructive pulmonary disease , or asthma . InterventionHome hospital care , including nurse and physician home visits , intravenous medications , continuous monitoring , video communication , and point-of-care testing . Main Measures Primary outcome was direct cost of the acute care episode . Secondary outcomes included utilization , 30-day cost , physical activity , and patient experience . Key Results Nine patients were r and omized to home , 11 to usual care .  Median direct cost of the acute care episode for home patients was 52 % ( IQR , 28 % ; p = 0.05 ) lower than for control patients . During the care episode , home patients had fewer laboratory orders ( median per admission : 6 vs. 19 ; p < 0.01 ) and less often received consultations ( 0 % vs. 27 % ; p = 0.04 ) . Home patients were more physically active ( median minutes , 209 vs. 78 ; p < 0.01 ) , with a trend toward more sleep . No adverse events occurred in home patients , one occurred in control patients . Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67 % ( IQR , 77 % ; p < 0.01 ) lower , with trends toward less use of home-care services ( 22 % vs. 55 % ; p = 0.08 ) and fewer readmissions ( 11 % vs. 36 % ; p = 0.32 ) . Patient experience was similar in both groups . Conclusions The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity . No significant differences in quality , safety , and patient experience were noted , with more definitive results awaiting a larger trial . Trial Registration NCT02864420 BACKGROUND With the advent of remote monitoring , current models of implantable cardioverter defibrillators ( ICDs ) have the possibility of sending automatic alert messages that allow early diagnosis of events such as lung fluid overload , atrial fibrillation and device integrity issues . Timely treatment of these events has the potential to improve patient outcome , but this has not as yet been proven . METHODS The MORE-CARE study is a multicenter r and omized controlled trial evaluating the efficacy of advanced device diagnostics and remote monitoring in improving the outcome of patients with biventricular ICDs . Up to 1720 patients with a st and ard indication for a biventricular ICD will be r and omized to st and ard in-office follow-up , or to a remote monitoring strategy using the CareLink network and involving automatic alerts for lung fluid overload , atrial fibrillation , and device integrity issues . The first phase aims at evaluating the delay between an alert event , and clinical action to the event . The second phase of the study will evaluate whether the remote monitoring strategy results in a significant reduction of a combined end point of total mortality or cardiovascular and device-related hospitalization . The duration of the study will be event-driven due to its sequential design . CONCLUSION MORE-CARE will evaluate the efficacy of remote monitoring for improving patient outcome in patients implanted with a biventricular ICD BACKGROUND Remote in-home monitoring ( RM ) of symptoms and physiological variables may allow early detection and treatment of exacerbations of chronic obstructive pulmonary disease ( COPD ) . It is unclear whether RM improves patient outcomes or healthcare re source utilization . This study determined whether RM is feasible in patients with COPD and if RM  reduces hospital admissions or length of stay ( LOS ) or improves health-related quality of life ( HRQOL ) . SUBJECTS AND METHODS Forty-four patients were r and omized to st and ard best practice care ( SBP ) ( n=22 ) or SBP+RM ( n=22 ) . RM involved daily recording of physiological variables , symptoms , and medication usage . RESULTS There were no differences ( mean±SD , SBP versus SBP+RM ) in age ( 68±8 versus 70±9 years ) , gender ( male : female 10:12 in both groups ) , or previous computer familiarity ( 59 % versus 50 % ) between groups . The SBP group had a lower forced expiratory volume in 1 s ( 0.66±0.24 versus 0.91±0.34 L , p<0.01 ) and more current smokers ( six versus none , p<0.05 ) . There were no differences in number of COPD -related admissions/year ( 1.5±1.8 versus 1.3±1.7 , p=0.76 ) , COPD -related LOS days/year ( 15.6±19.4 versus 11.4±19.6 , p=0.66 ) , total admissions/year ( 2.2±2.1 versus 2.0±2.3 , p=0.86 ) , total LOS days/year ( 22.1±29.9 versus 21.6±30.4 , p=0.88 ) , or HRQOL between the two groups . CONCLUSIONS The addition of RM to SBP was feasible but did not reduce healthcare utilization or improve quality of life in this group of patients already receiving comprehensive respiratory care AIMS To compare the cost-effectiveness ( CE ) of retropubic midurethral sling ( RMS ) versus transobturator midurethral sling ( TMS ) for the treatment of female stress urinary incontinence ( SUI ) . METHODS A Markov chain decision model was created to simulate treatment of SUI with RMS versus TMS .  Costing data were obtained from the Medicare RBRVS . Data regarding the efficacy and complications associated with RMS versus TMS was compiled from a literature review of 21 r and omized RCTs with a minimum of 12 months follow-up , as were corresponding utilities for different continence states . Deterministic and probabilistic estimates of cost-effectiveness ( CE ) for each procedure were calculated and compared , and sensitivity analyses were performed . RESULTS In the base-case deterministic analysis , the efficacy of RMS was 6.275 versus 6.272 QALYs for TMS . QALYs represent a measure of disease burden accounting for both quantity and quality of life lived and are used to assess the monetary value of a medical intervention . The average cost for treatment with  RMS however was higher at $ 9,579 versus $ 9,017 with TMS . TMS was therefore overall more cost-effective than RMS ( CE = $ 1,438/QALY vs. $ 1,527/QALY ) . Sensitivity analysis demonstrated that physician and sling characteristics such as device cost , surgeon fee , efficacy of treatment , operative time , and duration of hospitalization could all affect the relative CE of the therapies . CONCLUSIONS Our study demonstrated that TMS was more cost-effective than RMS as a treatment for female SUI . The efficacy of the two treatments could be affected by physician and sling characteristic factors Heart failure ( HF ) is a major and growing public health problem in the United States . On the basis of current trajectories , it has been estimated that , over the next 20 years , the prevalence of HF will increase by 25 % , from 2.8 % to 3.5 % of the population ( Figure 1).1 The increased prevalence may be expected to contribute to an increase in annual direct medical costs from the present estimate of $ 24.7 billion to approximately $ 77.7 billion , in 2008 dollars . At the same time , indirect costs — that is , costs related to lost productivity due to morbidity and mortality — may be expected to increase from $ 9.7 to $ 17.4 billion . If current legislative and regulatory efforts are successful at exp and ing healthcare access while improving affordability , systematic approaches must be developed and implemented to drive cost-effectiveness . The management of patients with HF will be front and center in efforts to achieve this goal . Although many questions remain , extensive research performed to date indicates that certain disease management interventions cost-effectively improve clinical outcomes in patients with HF . Home monitoring — providing continuity of patient assessment and care beyond the hospital and conventional ambulatory setting s — has been central among the elements of these programs . Figure 1 . Twenty-year projections for United States heart failure prevalence and associated direct medical costs based on current trends . Adapted from Heidenreich et al1 with permission of the publisher . Response by Desai on p 827 # # # Heart Failure Disease Management and Home Monitoring Home monitoring has been integral to most HF disease management programs , with demonstrable clinical benefit in r and omized , controlled trials . A proposal for categorizing the generic components of disease management programs2 may be applied to define the elements of a HF program as 1 ) optimizing treatment prescriptions ; 2 ) patient and caregiver education — including adherence to medication and dietary recommendations , self-monitoring , and connectivity to a healthcare provider ; and 3 ) ongoing monitoring and responsiveness to BACKGROUND Serial measurements of N-terminal pro-B type natriuretic peptide ( NT-proBNP ) provide prognostic information in patients with chronic heart failure ( HF ) . Changes in NT-proBNP concentrations parallel prognosis ; however , it remains unclear whether HF care with a goal to maximize medical therapy and also lower NT-proBNP concentrations is superior to st and ard HF care alone . AIMS The aim of the study was to evaluate the hypothesis that an HF strategy guided by NT-proBNP reduces cardiovascular events compared to st and ard of care HF management . METHODS In a prospect i ve r and omized single-center trial , subjects with New York Heart Association class II to IV systolic HF ( left ventricular ejection fraction < or = 40 % ) will be enrolled . Both groups will receive st and ard HF management ( with a goal for minimizing HF symptoms and achieving maximal dosages of therapies with proven mortality benefit in HF ) , whereas one group ( " NT-proBNP " ) will also have treatment adjustments to reduce NT-proBNP concentrations < or = 1,000 pg/mL. The primary end point of the trial is total cardiovascular events for a 1-year period ; secondary end points will include effects of NT-proBNP-guided care on cardiac structure and function , quality of life , and total costs of care .  RESULTS Enrollment began in 2006 ; of the original 300 planned , thus far , 151 subjects have been r and omized . Interim analysis in November 2009 indicated significant reduction of events in the NT-proBNP arm . Full results are expected in 2010 . CONCLUSIONS The Pro-B Type Natriuretic Peptide Outpatient Tailored Chronic Heart Failure Therapy ( PROTECT ) Study will test the hypothesis that therapy guided by NT-proBNP concentrations will be superior to st and ard of care HF management ( www . clinical trials.gov identifier NCT00351390 ) Abstract Objectives . To evaluate whether a new home intervention system ( HIS , OPTILOGG ® ) consisting of a specialised software , a tablet computer ( tablet ) wirelessly connected to a weight scale may improve self-care behaviour , health-related quality of life ( HRQoL ) , knowledge about heart failure ( HF ) and reduce hospital days due to HF . Design . 82 patients ( 32 % females ) with mean age : 75 ± 8 years hospitalised with HF were r and omised at discharge to an intervention group ( IG ) equipped with the HIS or to a control group ( CG ) receiving st and ard HF information only . The tablet contained information about HF and lifestyle advice according to current guidelines . It also showed present dose of diuretic , changes in patient-measured weight and HRQoL over time . Results . After 3 months the IG displayed a dramatic improvement in self-care with p < 0.05 ( median IG : 17 [ IQR : 13 , 22 ] and CG : 21 [ IQR : 17 , 25 ] ) . The disease-specific HRQoL was measured by Kansas City Cardiomyopathy Question naire . The IG had significantly higher score ( median IG : 65.1 [ IQR : 38.5 , 83.3 ] vs. CG : 52.1 [ IQR : 41.1 , 64.1 ] p < 0.05 ) and an improved physical limitation ( median IG : 54.2 [ IQR : 37.7 , 83.3 ] vs. CG : 45.8 [ IQR : 25.0 , 54.2 ] p < 0.05 ) There was no difference in knowledge . IG showed fewer HF-related days in the hospital , with 1.3 HF-related hospital days/patient versus 3.5 in CG ( risk ratio : 0.38 ; 95 % confidence interval : 0.31–0.46 ; p < 0.05 ) . Conclusion . HF patients with a HIS tablet computer and scale improved in self-care and HRQoL. Days in hospital due to HF were reduced . A medical device that is easy to use can be a valuable tool for improving self-care and outcome in patients with HF Background The benefit of self-monitoring of blood glucose ( SMBG ) in people with type 2 diabetes on diet or oral agents other than sulphonylureas  remains uncertain . Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results . A recent systematic review concluded that SMBG was not cost-effective . However , what was unclear was whether a cheaper method of self-monitoring ( such as urine glucose monitoring ) could produce comparable benefit and patient acceptability for less cost . Methods / Design The DESMOND SMBG trial is comparing two monitoring strategies ( blood glucose monitoring and urine testing ) over 18 months when incorporated into a comprehensive self-management structured education programme . It is a multi-site cluster r and omised controlled trial , conducted across 8 sites ( 7 primary care trusts ) in Engl and , UK involving individuals with newly diagnosed Type 2 diabetes . The trial has 80 % power to demonstrate equivalence in mean HbA1c ( the primary end-point ) at 18 months of within ± 0.5 % assuming 20 % drop out and 20 % non-consent . Secondary end-points include blood pressure , lipids , body weight and psychosocial measures as well as a qualitative sub- study . Practice s were r and omised to one of two arms : participants attend a  DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose . The programme is delivered by accredited educators who received specific training about equipoise . Biomedical data are collected and psychosocial scales completed at baseline , and 6 , 12 , and 18 months post programme . Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring . Discussion The DESMOND SMBG trial is design ed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes . Strengths include a setting in primary care , a cluster design , a health economic analysis , a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub- study .Trial registration IS RCT N : IS RCT N95696668 It was postulated that home hospitalisation ( HH ) of selected chronic obstructive pulmonary disease ( COPD ) exacerbations admitted at the emergency room ( ER ) could facilitate a better outcome than conventional hospitalisation . To this end , 222 COPD patients ( 3.2 % female ; 71±10 yrs ( mean±sd ) ) were r and omly assigned to HH ( n=121 ) or conventional care ( n=101 ) . During HH , integrated care was delivered by a specialised nurse with the patient 's free-phone access to the nurse ensured for an 8‐week follow-up period . Mortality ( HH : 4.1 % ; controls : 6.9 % ) and hospital readmissions ( HH : 0.24±0.57 ; controls : 0.38±0.70 ) were similar in both groups . However , at the end of the follow-up period , HH patients showed : 1 ) a lower rate of ER visits ( 0.13±0.43 versus 0.31±0.62 ) ; and 2 ) a noticeable improvement of quality of life ( Δ St George 's Respiratory Question naire ( SGRQ ) , −6.9 versus −2.4 ) . Furthermore , a higher percentage of patients had a better knowledge of the disease ( 58 % versus 27 % ) , a better self-management of their condition ( 81 % versus 48 % ) , and the patient 's satisfaction was greater . The average overall direct cost per HH patient was 62 % of the costs of conventional care , essentially due to fewer days of inpatient hospitalisation ( 1.7±2.3 versus 4.2±4.1 days ) . A comprehensive home care intervention in selected chronic obstructive pulmonary disease exacerbations appears as cost effective . The home hospitalisation intervention  generates better outcomes at lower costs than conventional care Background Cardiac rehabilitation improves health-related quality of life ( HRQoL ) and reduces hospitalizations in patients with heart failure , but international uptake of cardiac rehabilitation for heart failure remains low . Design and methods The aim of this multicentre r and omized trial was to compare the REACH-HF ( Rehabilitation EnAblement in CHronicHeart Failure ) intervention , a facilitated self-care and home-based cardiac rehabilitation programme to usual care for adults with heart failure with reduced ejection fraction ( HFrEF ) . The study primary hypothesis was that the addition of the REACH-HF intervention to usual care would improve disease-specific HRQoL ( Minnesota Living with Heart Failure question naire ( MLHFQ ) ) at 12 months compared with usual care alone . Results The study recruited 216 participants , predominantly men ( 78 % ) , with an average age of 70 years and mean left ventricular ejection fraction of 34 % . Overall , 185 ( 86 % ) participants provided data for the primary outcome . At 12 months , there was a significant and clinical ly meaningful between-group difference in the MLHFQ score of –5.7 points ( 95 % confidence interval –10.6 to –0.7 ) in favour of the REACH-HF intervention group ( p = 0.025 ) . With the exception of patient self-care ( p < 0.001 ) there was no significant difference in other secondary outcomes , including clinical events ( p > 0.05 ) at follow-up compared with usual care . The mean cost of the REACH-HF intervention was £ 418 per participant . Conclusions The novel REACH-HF home-based facilitated intervention for HFrEF was clinical ly superior in disease-specific HRQoL at 12 months and offers an affordable alternative to traditional centre-based programmes to address current low cardiac rehabilitation uptake rates for heart failure Context Case management by nurses improves outcomes for patients with heart failure , but studies have targeted patients at high risk for poor outcomes because of sociodemographic or clinical factors . Whether such programs benefit low-risk patients with heart failure is unknown . Contribution Among 462 patients in 1 staff-model health maintenance organization who were hospitalized with heart failure , those r and omly assigned to nurse care management  had rates of rehospitalization and death similar to rates in those who received usual care . Implication s Care management for heart failure may offer limited benefit for patients with clinical and sociodemographic characteristics that put them at low risk for hospitalization or death . The Editors The societal and personal burden of heart failure is large and is growing apace with the aging of the population ( 1 ) . Heart failure is the largest Medicare expenditure and is the leading cause of hospitalization for persons 65 years of age or older ( 2 ) . Rates of hospital readmission within 6 months range from 25 % to 50 % ( 3 ) . Moreover , behavioral factors , such as nonadherence to diet and medications , and social factors , such as social isolation and indigence , frequently contribute to early rehospitalizations ( 3 - 4 ) . Previous studies of specialized treatment programs for heart failure have targeted clinical ly high-risk , medically underserved population s. These studies demonstrated reductions in rehospitalization for heart failure and , to a lesser extent , rehospitalization for all causes ( 4 - 6 ) . In a pilot study conducted at a single Kaiser Permanente medical center in 1994 to 1995 , we found a statistically significant reduction in rehospitalization rates during a 3-month period among low-risk patients with heart failure who received nurse care management over a 6-month period ( 7 ) . The present study evaluated nurse care management for heart failure in a low-risk population of patients selected from several medical centers in the same large health maintenance organization ( HMO ) . Methods Design This was a r and omized , controlled trial of a nurse care management system for heart failure . Patient Sample We selected patients who were hospitalized with a provisional diagnosis of heart failure from Kaiser Permanente medical centers located in San Francisco , Vallejo , Walnut Creek , Sacramento , and Roseville , California , between May 1998 and October 2000 .  Hospital-based project nurses review ed hospital charts to screen for patients with new-onset or worsening heart failure on the basis of 1 ) shortness of breath ( dyspnea at rest , including orthopnea or paroxysmal nocturnal dyspnea ) and 2 ) at least 1 corroborating clinical sign ( pulmonary congestion on examination , including rales , crackles , or wheezes ) or radiologic abnormality ( pulmonary congestion on chest radiograph ) consistent with heart failure . We excluded patients who were scheduled for coronary artery bypass or valvular surgery ; had undergone cardiac surgery in the preceding 8 weeks ; had a serum creatinine value of 13.26 mol/L ( 5 mg/dL ) or greater ; were receiving dialysis or awaiting renal transplantation ; had a history of severe pulmonary disease requiring home oxygen ; had 1 or more additional diseases that were expected to result in death within 1 year ; had cognitive mental deficits , substance abuse , or severe psychiatric disorders ; or were expected to move from the area within 1 year . We did not use measurements of left ventricular function by echocardiography , radionuclide angiography , or contrast angiography as selection criteria . Among the 59 % of patients who had left ventricular ejection fraction measured , 28 % had an ejection fraction less than 0.40 and 31 % had an ejection fraction of 0.40 or greater . Study nurses interviewed patients during hospitalization or by telephone within 2 weeks after discharge , explained the purpose of the study , and obtained written informed consent . Research staff who were not associated with delivering the intervention r and omly assigned patients to treatment conditions by using sealed assignments . Equal numbers of patients were allocated to the 2 groups in each medical center by using the Efron procedure ( 8) . Physicians were notified of r and omization assignment by letter . The institutional review boards at Stanford University and Kaiser Permanente approved the study . Baseline Data Collection Baseline data , recorded by staff nurses on st and ardized forms , included sociodemographic characteristics , self-reported illnesses , medications , and results of st and ard diagnostic studies and laboratory tests . Treatment Environment Before the study , the investigators met with the medical staffs of the 5 participating hospitals to present and discuss the research protocol , including detailed descriptions of the planned interactions between the nurse care managers and the medical staff . The medical staffs were multispecialty groups of 20 to 60 physiciansapproximately 480 physicians total . After r and omization , all patients continued to receive usual care , including instruction on diet , drug adherence , physical activity , and response to changing symptoms .  Intervention In addition to usual care , patients in the intervention group received a physician-directed , nurse-managed , home-based program for heart failure developed by the investigators ( 9 ) . Originally design ed for coronary risk factor management , this program was exp and ed to encompass heart failure . It incorporated the features of best practice design ated by Rich ( 10 ) : coordination of care across disciplines , patient and caregiver education , enhancement of self-management skills , effective follow-up , and guidelines -based medications for heart failure . Our system also incorporated the principles of heart failure management developed by the Cardiovascular Nursing Council of the American Heart Association ( 11 ) . The st and ardized , telephone-mediated intervention included the following elements : initial educational session , including a videotape ; baseline telephone counseling session ; nurse-initiated follow-up telephone contacts ; pharmacologic management ; and nurse-initiated communication with physicians . The initial 1-hour educational session with a nurse occurred in the patient 's medical center . Patients received printed educational material s , including methods for self-monitoring of symptoms , body weight , and medications ; a dietary management workbook ; food-frequency question naires ; and instructions on how to access emergency care in case symptoms abruptly worsened . Patients viewed a videotape portraying the treatment process . Two experienced Stanford-based nurse care managers provided a 45-minute baseline telephone counseling session within 1 week of r and omization ; subsequent nurse contacts were tailored to the needs of the individual patients . Nurse-initiated follow-up telephone contacts with patients during daytime weekday hours were scheduled at weekly intervals for 6 weeks ; biweekly for 8 weeks ; monthly for 3 months ; bimonthly for 6 months ; and as needed to monitor patients ' medications , laboratory assessment s , symptoms , and other medical problems . We based pharmacologic management for heart failure on published treatment guidelines ( 12 , 13 ) . The nurse care managers obtained permission from physicians to initiate and regulate pharmacologic therapy for heart failure according to study protocol . Nurse-initiated communication with physicians about patients ' current medical status was maintained and specific management problems were addressed . Nurse care managers spent an average of 9 hours per patient coordinating the treatment plan with patients and physicians during the first year . The intervention did not include consultation with social services to facilitate discharge planning or home visits after discharge . Measurement Research staff who were not associated with , and were blinded to , the intervention conditions measured health outcomes at 12 months . On the basis of review of the Kaiser Permanente medical records , project nurses used st and ardized forms to record the cause , number , and duration of hospitalizations and emergency department visits during the 12-month follow-up period . Kaiser Permanente provided more than 90 % of all care . Two cardiologists who were not associated with implementing the intervention review ed medical records on deaths , rehospitalizations , and emergency department visits to determine whether these events were primarily due to heart failure or due to other causes . They did not use discharge diagnoses recorded in the medical record to make these judgments . Rehospitalizations and emergency department visits were classified as either due to heart failure or due to other causes ; the latter were classified as cardiac or noncardiac . Outcomes The primary outcome of the study was the time to first rehospitalization for heart failure or for any cause . In our analysis , we treated deaths occurring before rehospitalization as censored data . However , analysis in which we classified deaths occurring before rehospitalization as outcome events result ed in similar conclusions , primarily because most observed deaths occurred after a rehospitalization . Secondary outcomes were the time to a composite outcome of death , rehospitalization , or emergency department visits for cardiac cause or for any cause , the proportion of patients receiving recommended pharmacotherapy , and the rate of outpatient clinic and emergency department visits . We based the study 's power on a proposed reduction in the risk for rehospitalization for heart failure from 21 % to 13 % , corresponding to a number needed to treat for benefit of 12.5 . We expected that the actual number needed to treat for benefit would be less than 12.5 . Statistical Analysis We evaluated the effect of care management on rehospitalization rates by using KaplanMeier survival curves and Cox proportional hazards regression models . We compared nominal variables by using chi-square tests , ordered variables by Background Evidence that home telemonitoring for patients with chronic heart failure ( CHF ) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage . Methods Between January 2010 and June 2013 , patients with a confirmed diagnosis of CHF were enrolled and r and omly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system ( Motiva ® ) . The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio ( ICER ) established by the groups ’ difference in total cost and in the combined clinical endpoint “ days alive and not in hospital nor inpatient care per potential days in study ” within the follow-up of 12 months . Results A total of 621 predominantly male patients were enrolled , whereof 302 patients were assigned to the intervention group and 319 to the control group .  Ischemic cardiomyopathy was the leading cause of heart failure . Despite r and omization , subjects of the control group were more often in NYHA functional class III – IV , and exhibited peripheral edema and renal dysfunction more often . Additionally , the control and intervention groups differed in heart rhythm disorders . No differences existed regarding risk factor profile , comorbidities , echocardiographic parameters , especially left ventricular and diastolic diameter and ejection fraction , as well as functional test results , medication and quality of life . While the observed baseline differences may well be a play of chance , they are of clinical relevance . Therefore , the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances . Conclusions CardioBBEAT provides prospect i ve outcome data on both , clinical and health economic impact of home telemonitoring in CHF . The study differs by the use of a high evidence level r and omized controlled trial ( RCT ) design along with actual cost data obtained from health insurance companies . Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care . Overall , it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System . Trial registration Clinical Trials.gov NCT02293252 ; date of registration : 10 November Purpose The aim of the present study is to evaluate if remote monitoring with the CareLink Network may improve clinical management of tachyarrhythmias and heart failure episodes in patients treated with biventricular defibrillators ( CRT-D ) .  Methods Patients implanted with CRT-D for more than 6 months received the CareLink monitor and were trained to perform device interrogation . At-home transmissions were scheduled at 2 weeks , 1 and 2 months after training , with a final in-office visit after 3 months . Results Sixty-seven patients performed 264 data transmissions . Twenty-three unscheduled data transmissions were requested by the centers after patient contact . Ventricular tachyarrhythmias were reported in nine patients during 16 data review s. Thirteen data review s ( 81 % ) were performed remotely via CareLink transmissions ( nine scheduled and four unscheduled ) , in seven patients . Of these events , in two cases ( 15 % ) in-hospital visits were requested , while in 11 ( 85 % ) no action was needed and no additional in-clinic visits were scheduled . During the study period , in 20/28 ( 71 % ) intra-thoracic impedance alerts , the patients remotely transmitted their device data . After remote data review , in ten cases drug therapy was adjusted by phone and in four cases no action was needed and the patient reassured . In six episodes an in-hospital extra visit was scheduled . On the whole , in 14 cases ( 70 % ) , the patient could be managed remotely avoiding a visit to the hospital . Conclusions Our study showed that remote follow-up is an efficient method to manage tachyarrhythmias and heart failure episodes in  CRT-D patients . Early reaction to clinical events may improve overall patient care Context Minority and low-income women have low screening rates for cancer .  Contribution In this trial from 11 community and migrant health centers in New York City , 1413 women overdue for cancer screening were r and omly assigned to receive a telephone-based intervention ( delivered by 8 prevention care managers ) or usual care . The intervention included information about breast , cervical , and colorectal cancer and motivational and logistical support for obtaining screening . Within 18 months , the screening rates for all 3 forms of cancer increased more with telephone support than through usual care . Implication s Telephone support delivered by trained personnel can improve cancer screening rates among some minority , low-income women . The Editors Higher screening rates for breast , cervical , and colorectal cancer could reduce cancer mortality rates substantially ( 1 - 4 ) . Current cancer screening rates are particularly disappointing among ethnic minorities and individuals with low socioeconomic status ( 5 , 6 ) who often present with late-stage diagnoses ( 7 ) and have high mortality rates ( 8 , 9 ) . Interventions to increase cancer screening have shown limited sustainability and effect on health care disparities . A previous study showed that an office systems approach , which used a medical record flowsheet and practice teamwork , increased screening rates by 20 % to 33 % in small rural community practice s ( 10 ) ; however , a similar intervention was less effective in larger urban practice s ( 11 ) . An office intervention  in low-income setting s in Florida increased mammography use and home fecal occult blood testing at 12 months ( 12 ) , but rates decreased substantially after research support ended ( 13 ) . Use of the telephone to support cancer screening is well documented ( 14 - 18 ) , but interventions have typically addressed a single form of cancer screening . In some setting s , telephone infrastructures to support childhood immunization ( 19 ) and patients with chronic illnesses ( 20 - 23 ) already exist . These infrastructures could add screening support for patients who are already enrolled , or they could exp and services to others while making minimal additional dem and s on primary care practice s ( 24 ) . This paper reports the results of a r and omized , controlled trial that tested the effect of central ized telephone care management on cancer screening rates among women 50 to 69 years of age who obtained care at community and migrant health centers in New York City . Methods Setting s Federally qualified community and migrant health centers provide comprehensive community-oriented primary care to over 12 million patients nationally ( 25 ) and are uniquely positioned to deliver cancer screenings to underserved and minority population s. We sought participation from 15 of the 21 community and migrant health centers in New York City because of their anticipated ability to provide sufficient patients for the study and their affiliations with tertiary care facilities that conduct mammography and colorectal screening and provide follow-up services for abnormal test results . Of these 15 sites , 2 were involved in competing research projects , 2 had few patients who were likely to be eligible and therefore served as pilot sites , and the remaining 11 participated . Clinical Directors Network , a practice -based research network in New York City , was responsible for recruiting clinicians , practice s , and women and for implementing the intervention and evaluation . The project was approved by the Committee for the Protection of Human Subjects at Dartmouth College , by the institutional review board at Clinical Directors Network , and by all relevant bodies responsible for review ing research at participating community and migrant health centers . Patients Recruitment Women were approached by research assistants during routine visits to the centers or were referred by a clinician . Research assistants explained the study and obtained written informed consent from women who agreed to participate . Women were compensated $ 15 for participating in an interview whether or not they met eligibility criteria . Eligibility Eligible women were 50 to 69 years of age , were overdue for at least 1 cancer screening according to their medical records , were patients of the center for at least 6 months , and had no plans to move or change health centers within 15 months . We excluded women whose primary language was not English , Spanish , or Haitian Creole and those who were acutely ill or currently receiving cancer treatment . After we obtained consent , a research assistant review ed patient medical records to confirm eligibility . Mammography and Papanicolaou tests that were performed within the past year were seen as evidence of breast and cervical cancer screening , respectively , whereas reports of home fecal occult blood testing within the past year , sigmoidoscopy within the past 5 years , or colonoscopy within the past 10 years were seen as evidence of colorectal cancer screening . Women whose charts indicated that they were up to date on all 3 cancer screenings were excluded . We also excluded women with unresolved abnormal screening results ( for example , positive results on home fecal occult blood testing ; mammography results that were categorized as American College of Radiology level 0 , 4 , or 5 ; and certain Papanicolaou test results ) and notified their physicians of these findings . Design Eligible , consenting women were grouped by center , duration of enrollment at their center ( 12 months or > 12 months ) , and the number of cancer screenings that they had received at recommended intervals ( 0 or 1 screening or 2 screenings ) . The New Yorkbased research assistant assigned women in each group to receive the intervention or usual care by using sealed r and omization forms that were produced by Dartmouth College staff with a computer-based r and om-number generator . Patients were informed of their group assignment individually by telephone . At time of consent , all women received the publication titled Put Prevention into Practice Personal Health Guide ( 26 ) , which contained information regarding recommended preventive services . Women who were assigned to the usual care group received a single telephone call during which trial staff answered questions about preventive care , informed women of their usual care status , advised them to obtain needed preventive care from their primary care clinician , and thanked them for their participation . Women who were assigned to the intervention group received a series of telephone support calls from a trained prevention care manager who was monitored to ensure quality and consistency . In much the same way that patient navigators guide women through the health care system during cancer treatment ( 27 ) , prevention care managers facilitated the screening process for each woman by addressing barriers that prevent or delay receipt of cancer screenings . Prevention care managers received 7 hours of training , including an overview of the U.S. Preventive Services Task Force guidelines ( 28 - 30 ) ; a review of barriers to breast , cervical , and colorectal cancer screenings ; and detailed explanations of the targeted screenings . Additional training included role-playing telephone calls during which the managers used the intervention scripts . Thereafter , logs were review ed in monthly meetings to ensure fidelity to the intervention . The 8 prevention care managers were women , and most were college graduates . Their assignments were determined by patient language needs . Each care manager focused most of her work on patients from 1 or 2 sites while supporting smaller numbers of patients from other sites ; contact with clinicians was limited . During the first call with a patient in the intervention group , the prevention care manager answered questions about the health guide and confirmed or up date d screening date s found in the woman 's medical record . She next determined how ready the woman was to act on each screening ( 31 ) and worked with the woman to prioritize overdue screenings . The prevention care manager then provided motivational support , responding to each participant 's specific barriers to screening by using a structured script that was developed through an earlier series of interviews with women ( 32 ) . Some participants had been advised during office visits with their clinicians to undergo screening ; those who had not received such recommendations were sent a written recommendation from their clinician . Women who reported that they had difficulty communicating with their physician were sent brightly colored patient activation cards that listed overdue screenings , which they could share with their clinician at their next appointment . Care managers also scheduled appointments , provided accurate information about screenings over the telephone and by mail , prompted women with appointment reminder calls and letters , provided directions to screening facilities , and helped women to find a means of transportation to appointments . During subsequent calls , which continued for 18 months or until the patient was up to date for all screenings , the prevention care manager asked about future appointments and screenings the patient had received since the last call . The manager then responded to new and ongoing barriers for remaining overdue screenings . Only clinicians , not care managers , were responsible for ordering screenings  at all but 2 centers , which permitted care managers to mail home fecal occult blood test kits directly to women who were willing to perform this test . Evaluation Descriptive data on the centers were gathered from surveys that were completed by clinicians and clinical directors . Outcome data were based on review s of patient medical records , which were conducted at least 3 months after the intervention period to allow for the time lag between receipt of a service and the availability of documentation . Data included patient demographic characteristics , screening date s and results , chronic
No favourable effect on mortality was observed with STS HM .
Similar reductions were observed in all-cause hospitalisations for TM interventions , whereas STS interventions had no major effect .
STS HM was dominated by usual care .
Similar results were observed in scenario analyses performed using higher costs of usual care , higher costs of STS HH and lower costs of TM during office hours .
As a result , the economic model developed scenarios for different RM classifications and their costs were estimated using bottom-up costing methods .
Despite wide variation in usual care and RM strategies , cost-effectiveness analyses suggest that TM during office hours was an optimal strategy ( in most costing scenarios ) .
However , clarity was lacking among descriptions of the components of RM packages and usual care and there was a lack of robust estimation of costs .
BACKGROUND Remote monitoring ( RM ) strategies have the potential to deliver specialised care and management to patients with heart failure ( HF ) .
OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of home telemonitoring ( TM ) or structured telephone support ( STS ) strategies compared with usual care for adult patients who have been recently discharged ( within 28 days ) from acute care after a recent exacerbation of HF .
The review included r and omised controlled trials ( RCTs ) or observational cohort studies with a contemporaneous control group that included the following RM interventions : ( 1 ) TM ( including cardiovascular implanted monitoring devices ) with medical support provided during office hours or 24/7 ; ( 2 ) STS programmes delivered by human-to-human contact ( HH ) or human-to-machine interface ( HM ) .