Development of mWellcare: an mHealth intervention for integrated management of hypertension and diabetes in low-resource settings mHealth intervention to support asthma self-management in adolescents: the ADAPT study Effective behavioral intervention strategies using mobile health applications for chronic disease management: a systematic review Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial A randomized trial evaluating an mHealth system to monitor and enhance adherence to pharmacotherapy for alcohol use disorders Information system support as a critical success factor for chronic disease management: Necessary but not sufficient Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS): study protocol for a randomized controlled trial Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development Case management and self-management support for frequent users with chronic disease in primary care: a pragmatic randomized controlled trial Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol Optimising patient active role with a user-centred eHealth platform (CONCERTO+) in chronic diseases management: a study protocol for a pilot cluster randomised controlled trial A Randomized Trial of Mobile Health Support for Heart Failure Patients and Their Informal Caregivers: Impacts on Caregiver-reported Outcomes Older adults’ readiness to engage with eHealth patient education and self-care resources: a cross-sectional survey Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India Improved delivery of cardiovascular care (IDOCC) through outreach facilitation: study protocol and implementation details of a cluster randomized controlled trial in primary care Evaluation of a nurse-led disease management programme for chronic kidney disease: a randomized controlled trial. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial Case Management for Depression by Health Care Assistants in Small Primary Care Practices Feasibility and Preliminary Outcomes of a Web and Smartphone–Based Medication Self-Management Platform for Chronically Ill Patients Implementation and effectiveness of 'care navigation', coordinated management for people with complex chronic illness: rationale and methods of a randomised controlled A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol Understanding potential uptake of a proposed mHealth program to support caregiver home management of childhood illness in a resource-poor setting: a qualitative evaluation. Understanding the Success of Promotoras in Increasing Chronic Diseases Screening ‘Getting your Life Back on Track after Stroke’: A Phase II Multi-Centered, Single-Blind, Randomized, Controlled Trial of the Stroke Self-Management Program Vs. the Stanford Chronic Condition Self-Management Program or Standard Care in Stroke Survivors Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management) Mobile Health Technology for Atrial Fibrillation Management Integrating Decision Support, Education, and Patient Involvement: mAF App Trial. Pharmacist-Led Chronic Disease Management: A Systematic Review of Effectiveness and Harms Compared With Usual Care Effectiveness of chronic obstructive pulmonary disease self-management interventions in primary care settings: a systematic review. Incorporating Novel Mobile Health Technologies Into Management of Knee Osteoarthritis in Patients Treated With Intra-Articular Hyaluronic Acid: Rationale and Protocol of a Randomized Controlled Trial Chronically critically ill patients: health-related quality of life and resource use after a disease management intervention. Protocol for a randomised controlled trial of chronic disease self-management support for older Australians with multiple chronic diseases. Design Considerations in Development of a Mobile Health Intervention Program: The TEXT ME and TEXTMEDS Experience Addressing the needs of patients with multiple chronic illnesses: the case of diabetes and depression. Methodology of an ongoing, randomized, controlled trial to improve drug use for elderly patients with chronic heart failure. Rationale and design of the Medication adherence Improvement Support App For Engagement-Blood Pressure (MedISAFE-BP) trial. Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial Health Promotion Through Primary Care: Enhancing Self-Management With Activity Prescription and mHealth A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study Community-based care for chronic wound management: an evidence-based analysis. Home medication management review in outpatients with chronic diseases in Jordan: a randomized control trial A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System Performance Research Network, Bridgepoint Electronic Patient Reported Outcome Tool EHR‐Based Medication Support and Nurse‐Led Medication Therapy Management: Rationale and Design for a Three‐Arm Clinic Randomized Trial Are anxiety and depression addressed in primary care patients with chronic obstructive pulmonary disease? A chart review. A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol A Mobile Health Intervention to Improve Self-Care in Patients With Heart Failure: Pilot Randomized Control Trial Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial Systematic medical assessment, referral and treatment for diabetes care in China using lay family health promoters: protocol for the SMARTDiabetes cluster randomised controlled trial
ABSTRACT Background : Cardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India . Innovative approaches such as clinical decision support ( CDS ) software could play a major role in improving the quality of hypertension/diabetes care in primary care setting s. Objective : To describe the steps and processes in the development of mWellcare , a complex intervention based on mobile health ( mHealth ) technology . Methods : The Medical Research Council framework was used to develop mWellcare in four steps : ( 1 ) identify gaps in usual care through literature review and health facility assessment s ; ( 2 ) identify the components of the intervention through discussion s and consultations with experts ; ( 3 ) develop intervention ( clinical algorithms and mHealth system ) ; and ( 4 ) evaluate acceptability and feasibility through pilot testing in five community health centers . Results : Lack of evidence -based , integrated , and systematic management of chronic conditions were major gaps identified . Experts in information technology , clinical fields , and public health professionals identified intervention components to address these gaps . Thereafter , clinical algorithm context ualized to primary care setting s were prepared and the mWellcare intervention was developed . During the 2-month pilot , 631 patients diagnosed with hypertension and /or diabetes were registered , with a follow-up rate of 36.2 % . The major barrier was resistance to follow mWellcare recommended patient workflow , and to overcome it , we emphasized onsite training and orientation program to cover all health care team member in each CHC . Conclusion : A pilot-tested mWellcare intervention is an mHealth system with important components , i.e. integrated management of chronic conditions , evidence -based CDS , longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit , which will be used by nurses at primary health care setting s in India . The effectiveness and cost-effectiveness of the intervention will be tested through a cluster r and omized trial ( trial registration number NCT02480062 ) Purpose Poor medication adherence in adolescents with asthma results in poorly controlled disease and increased morbidity . The aim of the ADolescent Adherence Patient Tool ( ADAPT ) study is to develop an mHealth intervention to support self-management and to evaluate the effectiveness in improving medication adherence and asthma control . Intervention The ADAPT intervention consists of an interactive smartphone application ( app ) connected to a desktop application for health care providers , in this study , the community pharmacist . The app contains several functions to improve adherence as follows : 1 ) a question naire function to rate asthma symptoms and monitor these over time ; 2 ) short movie clips with medication and disease information ; 3 ) a medication reminder ; 4 ) a chat function with peers ; and 5 ) a chat function with the pharmacist . The pharmacist receives data from the patient ’s app through the desktop application , which enables the pharmacist to send information and feedback to the patient . Study design The ADAPT intervention is tested in a community pharmacy-based cluster r and omized controlled trial in the Netherl and s , aim ing to include 352 adolescents with asthma . The main outcome is adherence , measured by patient ’s self-report and refill adherence calculated from pharmacy dispensing records . In addition , asthma control , illness perceptions , medication beliefs , and asthma-related quality of life are measured . Conclusion This study will provide in-depth knowledge on the effectiveness of an mHealth intervention to support asthma self-management in adolescents . These insights will also be useful for adolescents with other chronic diseases Background Mobile health ( mHealth ) has continuously been used as a method in behavioral research to improve self-management in patients with chronic diseases . However , the evidence of its effectiveness in chronic disease management in the adult population is still lacking . We conducted a systematic review to examine the effectiveness of mHealth interventions on process measures as well as health outcomes in r and omized controlled trials ( RCTs ) to improve chronic disease management . Methods Relevant r and omized controlled studies that were published between January 2005 and March 2016 were search ed in six data bases : PubMed , CINAHL , EMBASE , the Cochrane Library , PsycINFO , and Web of Science . The inclusion criteria were RCTs that conducted an intervention using mobile devices such as smartphones or tablets for adult patients with chronic diseases to examine disease management or health promotion . Results Of the 12 RCTs review ed , 10 of the mHealth interventions demonstrated statistically significant improvement in some health outcomes . The most common features of mHealth systems used in the review ed RCTs were real-time or regular basis symptom assessment s , pre-programed reminders , or feedbacks tailored specifically to the data provided by participants via mHealth devices . Most studies developed their own mHealth systems including mobile apps . Training of mHealth systems was provided to participants in person or through paper-based instructions . None of the studies reported the relationship between health outcomes and patient engagement levels on the mHealth system . Conclusions Findings from mHealth intervention studies for chronic disease management have shown promising aspects , particularly in improving self-management and some health outcomes Background Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities ( eg , hypertension , diabetes ) . These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients ’ physiological data . This technology is also relatively inexpensive , has an intuitive interface , and provides the capability for real-time personalized feedback to help motivate patient self-efficacy . Automated summary reports of patients ’ adherence and blood pressure can easily be uploaded to providers ’ networks helping reduce clinical inertia by reducing regimen alteration time . Objective The aim of this study was to assess the feasibility , acceptability , and preliminary outcomes of a prototype mobile health ( mHealth ) medication and blood pressure ( BP ) self-management system for kidney transplant patients with uncontrolled hypertension . Methods A smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design . The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback . A 3-month proof-of-concept r and omized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray . Participants r and omized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging . Controls received st and ard of care and their adherence continued to be monitored with the medication tray reminders turned off . Providers received weekly summary reports of patient medication adherence and BP readings . Results Participation and retention rates were 41/55 ( 75 % ) and 31/34 ( 91 % ) , respectively . The prototype system appears to be safe , highly acceptable , and useful to patients and providers . Compared to the st and ard care control group ( SC ) , the mHealth intervention group exhibited significant improvements in medication adherence and significant reductions in clinic-measured systolic blood pressures across the monthly evaluations . Physicians made more anti-hypertensive medication adjustments in the mHealth group versus the st and ard care group ( 7 adjustments in 5 patients versus 3 adjustments in 3 patients ) during the 3-month trial based on the information provided in the weekly reports . Conclusions These data support the acceptability and feasibility of the prototype mHealth system . Further trials with larger sample sizes and additional biomarkers ( eg , whole blood medication levels ) are needed to examine efficacy and effectiveness of the system for improving medication adherence and blood pressure control  after kidney transplantation over longer time periods . Trial Registration Clinical trials.gov NCT01859273 ; http:// clinical trials.gov/ct2/show/NCT01859273 ( Archived by WebCite at http://www.webcitation.org/6IqfCa3A3 ) Background Nonadherence to prescribed medication regimens is a substantial barrier to the pharmacological management of alcohol use disorders . The availability of low-cost , sustainable interventions that maximize medication adherence would likely lead to improved treatment outcomes . Mobile health ( mHealth ) technologies are increasingly being adopted as a method of delivering behavioral health interventions and represent a promising tool for adherence interventions . We are evaluating a cell-phone – based intervention called AGATE that seeks to enhance adherence with regular text-messaging . Methods / Design A r and omized controlled effectiveness trial in the context of an eight-week open label naltrexone efficacy trial delivered in a naturalistic clinical setting . Treatment-seeking heavy drinkers ( N = 105 ) are currently being recruited and r and omly assigned to the AGATE intervention or a control condition .  Daily measures of alcohol use and medication side effects are being recorded via cell phone in both conditions . Additionally , participants r and omized to the AGATE condition receive medication reminders via SMS text message according to a schedule that adjusts according to their level of adherence . Discussion Results from this trial will provide initial information about the feasibility and efficacy of mHealth interventions for improving adherence to alcohol pharmacotherapies . Trial Registration NCT01349985 UNLABELLED Improvement of chronic disease management in primary care entails monitoring indicators of quality over time and across patients and practice s. Informatics tools are needed , yet implementing them remains challenging . OBJECTIVE To identify critical success factors enabling the translation of clinical and operational knowledge about effective and efficient chronic care management into primary care practice . DESIGN A prospect i ve case study of positive deviants using key informant interviews , process observation , and document review . SETTING A chronic disease management ( CDM ) collaborative of primary care physicians with documented improvement in adherence to clinical practice guidelines using a web-based patient registry system with CDM guideline -based flow sheet . PARTICIPANTS Thirty community-based physician participants using predominantly paper records , plus a project management team including the physician lead , project manager , evaluator and support team . ANALYSIS A critical success factor ( CSF ) analysis of necessary and sufficient pathways to the translation of knowledge into clinical practice . RESULTS A web-based CDM ' toolkit ' was found to be a direct CSF that allowed this group of physicians to improve their practice by tracking patient care processes using evidence -based clinical practice guideline -based flow sheets . Moreover , the information and communication technology ' factor ' was sufficient for success only as part of a set of seven direct CSF components including : health delivery system enhancements , organizational partnerships , funding mechanisms , project management , practice models , and formal knowledge translation practice s. Indirect factors that orchestrated success through the direct factor components were also identified . A central insight of this analysis is that a comprehensive quality improvement model was the CSF that drew this set of factors into a functional framework for successful knowledge translation . CONCLUSIONS In complex primary care setting s environment where physicians have low adoption rates of electronic tools to support the care of patients with chronic conditions , successful implementation may require a set of interrelated system and technology factors Background Medication regimens for asthma are particularly vulnerable to adherence problems because of the requirement for long-term use and periods of symptom remission experienced by patients . Pharmacists are suited to impact medication adherence given their training , skills , and frequent contact with patients . The Empowering pharmacists in asthma management through interactive SMS ( EmPhAsIS ) trial involves an intervention leveraging mobile health ( mHealth ) technology to support community pharmacy practice with the hypothesis of improved medication adherence in asthma . Methods / Design This study is a pragmatic pharmacy-based , cluster , r and omized controlled trial with 12 months of intervention delivery and follow-up . Pharmacies ( the clusters ) will be r and omized at a 1:1 ratio to provide intervention or usual care . The EmPhAsIS intervention consists of patient asthma education , short message service (SMS)-based monthly assessment of adherence , and follow-up of non-adherent individuals by community pharmacists . There are no inclusion or exclusion criteria for pharmacies . Patients are eligible if they : are 14 years of age or older , fill a prescription for inhaled corticosteroid ( either monotherapy or in a combination inhaler with long-acting beta-agonists ) , have been diagnosed with asthma , possess a mobile phone with SMS capabilities , and have no communication difficulties such as inability to communicate in English , or significant impairment in vision , hearing , or speech . The primary outcome is adherence to inhaled corticosteroids ascertained by the medication possession ratio , the ratio of the days of medication supplied to days in a given time interval . This study will also evaluate secondary outcomes including : asthma control , asthma-related quality of life , asthma-related hospital admissions , and use of reliever medications during the follow-up period . A nested economic evaluation using a probabilistic decision-analytic model will be used to perform a cost-effectiveness analysis from the societal perspective of the intervention compared with usual care over a 10-year time horizon . Discussion Considering the prevalence of asthma , the extent of the non-adherence problem in this disease , and the availability of effective treatments , there is a tremendous potential to reduce the burden of asthma through improving adherence . This is the first study of an intervention based on mobile communication technology involving community pharmacists in asthma management . Trial registration Clinical Trials.gov identifier : NCT02170883 ; date of registration : 19 June 2014 Background Oral chemotherapy is increasingly used in place of traditional intravenous chemotherapy to treat patients with cancer . While oral chemotherapy includes benefits such as ease of administration , convenience , and minimization of invasive infusions , patients receive less oversight , support , and symptom monitoring from clinicians . Additionally , adherence is a well-documented challenge for patients with cancer prescribed oral chemotherapy regimens . With the ever-growing presence of smartphones and potential for efficacious behavioral intervention technology , we created a mobile health intervention for medication and symptom management . Objective The objective of this study was to develop and evaluate the usability and acceptability of a smartphone app  to support adherence to oral chemotherapy and symptom management in patients with cancer . Methods We used a 5-step development model to create a comprehensive mobile app with theoretically informed content . The research and technical development team worked together to develop and iteratively test the app . In addition to the research team , key stakeholders including patients and family members , oncology clinicians , health care representatives , and practice administrators contributed to the content refinement of the intervention . Patient and family members also participated in alpha and beta testing of the final prototype to assess usability and acceptability before we began the r and omized controlled trial . Results We incorporated app components based on the stakeholder feedback we received in focus groups and alpha and beta testing . App components included  medication reminders , self-reporting of medication adherence and symptoms , an education library including nutritional information , Fitbit integration , social networking re sources , and individually tailored symptom management feedback .  We are conducting a r and omized controlled trial to determine the effectiveness of the app in improving adherence to oral chemotherapy , quality of life , and burden of symptoms and side effects . At every stage in this trial , we are engaging stakeholders to solicit feedback on our progress and next steps . Conclusions To our knowledge , we are the first to describe the development of an app design ed for people taking oral chemotherapy . The app addresses many concerns with oral chemotherapy , such as medication adherence and symptom management . Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients , caregivers , and clinicians . In our development process , we instantiated 7 of the 8 best practice s proposed in a recent review of mobile health app development . Our process demonstrated the importance of effective communication between research groups and technical teams , as well as meticulous planning of technical specifications before development begins . Future efforts should consider incorporating other proven strategies in software , such as gamification , to bolster the impact of mobile health apps . Forthcoming results from our r and omized controlled trial will provide key data on the effectiveness of this app in improving medication adherence and symptom management . Trial Registration Clinical Trials.gov NCT02157519 ; https:// clinical trials.gov/ct2/show/NCT02157519 ( Archived by WebCite at http://www.webcitation.org/6prj3xfKA Background Chronic diseases represent a major challenge for health care and social services . A number of people with chronic diseases require more services due to characteristics that increase their vulnerability . Given the burden of increasingly vulnerable patients on primary care , a pragmatic intervention in four Family Medicine Groups ( primary care practice s in Quebec , Canada ) has been proposed for individuals with chronic diseases ( diabetes , cardiovascular diseases , respiratory diseases , musculoskeletal diseases and /or chronic pain ) who are frequent users of hospital services . The intervention combines case management by a nurse with group support meetings encouraging self-management based on the Stanford Chronic Disease Self-Management Program . The goals of this study are to : ( 1 ) analyze the implementation of the intervention in the participating practice s in order to determine how the various context s have influenced the implementation and the observed effects ; ( 2 ) evaluate the proximal ( self-efficacy , self-management , health habits , activation and psychological distress ) and intermediate ( empowerment , quality of life and health care use ) effects of the intervention on patients ; ( 3 ) conduct an economic analysis of the efficiency and cost-effectiveness of the intervention . Methods / Design The analysis of the implementation will be conducted using realistic evaluation and participatory approaches within four categories of stakeholders ( Family Medicine Group and health centre management , Family Medicine Group practitioners , patients and their families , health centre or community partners ) . The data will be obtained through individual and group interviews , project documentation review s and by documenting the intervention . Evaluation of the effects on patients will be based on a pragmatic r and omized before-after experimental design with a delayed intervention control group ( six months ) . Economic analysis will include cost-effectiveness and cost-benefit analysis . Discussion The integration of a case management intervention delivered by nurses and self-management group support into primary care practice s has the potential to positively impact patient empowerment and quality of life and hopefully reduce the burden on health care . Decision-makers , managers and health care professionals will be aware of the factors to consider in promoting the implementation of this intervention into other primary care practice s in the region and elsewhere . Trial Registration Background Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes . Despite the benefits of CR , attendance at centre-based sessions remains low . Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR . The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zeal and adults diagnosed with CHD . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted at two Auckl and hospitals in New Zeal and . One hundred twenty participants will be r and omised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) . The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months , measured using a composite health behaviour score . Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence . Discussion This study is one of the first to examine an mHealth-delivered comprehensive CR program . Strengths of the trial include quality research design and in-depth description of the intervention to aid replication . If effective , the trial has potential to augment st and ard CR practice s and to be used as a model for other disease prevention or self-management programs . Trial registryAustralian New Zeal and Clinical Trials Registry : Introduction Multimorbidity increases care needs and primary care use among people with chronic diseases .  The Concerto Health Program ( CHP ) has been developed to optimise chronic disease management in primary care services . However , in its current version , the CHP primarily targets clinicians and does not aim to answer directly patients ’ and their informal caregivers ’ needs for chronic disease management . Various studies have shown that interventions that increase patient activation level are associated with better health outcomes . Furthermore , educational tools must be adapted to patients and caregivers in terms of health literacy and usability . This project aims to develop , implement and evaluate a user-centred , multifunctional and personalised eHealth platform ( CONCERTO+ ) to promote a more active patient role in chronic disease management and decision-making . Methods and analysis This project uses a collaborative research approach , aim ing at the personalisation of CHP through three phases : ( 1 ) the development of one module of an eHealth platform based on scientific evidence and user-centred design ; ( 2 ) a feasibility study of CONCERTO+ through a pilot cluster r and omised controlled trial where patients with chronic diseases from a primary healthcare practice will receive CONCERTO+ during 6 months and be compared to patients from a control practice receiving usual care and ( 3 ) an analysis of CONCERTO+ potential for scaling up . To do so , we will conduct two focus groups with patients and informal caregivers and individual interviews with health professionals at the two study sites , as well as health care managers , information officers and representatives of the Ministry of Health . Ethics and dissemination This study received ethical approval from Ethics Committee of Université Laval . The findings will be used to inform the effectiveness of CONCERTO+  to improve management care in chronic diseases . We will disseminate findings through presentations in scientific conferences and publication in peer- review ed journals . Trial registration number NCT03628963 ; Pre- results Background : Mobile health services may improve chronic illness care , but interventions rarely support informal caregivers ’ efforts . Objectives : To determine whether automated feedback to caregivers of chronic heart failure patients impacts caregiving burden and assistance with self-management . Research Design : R and omized comparative effectiveness trial . Subjects : A total of 369 heart failure patients were recruited from a Veterans Health Administration health care system . All patients participated with a “ CarePartner ” or informal caregiver outside their household . Intervention : Patients r and omized to “ st and ard mHealth ”  received weekly automated self-care support calls for 12 months with notifications about problems sent to clinicians . “ mobile health+CarePartner ” ( mHealth+CP ) patients received identical services , plus email summaries and suggestions for self-care assistance automatically sent to their CarePartners . Measures : At baseline , 6 , and 12 months , CarePartners completed assessment s of caregiving strain , depressive symptoms , and participation in self-care support . Results : mHealth+CP CarePartners reported less caregiving strain than controls at both 6 and 12 months ( both P⩽0.03 ) . That effect as well as improvements in depressive symptoms were seen primarily among CarePartners reporting greater burden at baseline ( P⩽0.03 for interactions between arm and baseline strain/depression at both endpoints ) . Although most mHealth+CP CarePartners increased the amount of time spent in self-care support , those with the highest time commitment at baseline reported decreases at both follow-ups ( all P<0.05 ) . mHealth+CP CarePartners reported more frequently attending patients ’ medical visits at 6 months ( P=0.049 ) and greater involvement in medication adherence at both endpoints ( both P⩽0.032 ) . Conclusions : When CarePartners experienced significant caregiving strain and depression , systematic feedback about their patient-partner decreased those symptoms . Feedback also increased most CarePartners ’ engagement in self-care Background This study examined access to digital technologies , skills and experience , and preferences for using web-based and other digital technologies  to obtain health information and advice among older adults in a large health plan . A primary aim was to assess the extent to which digital divides by race/ethnicity and age group might affect the ability of a large percentage of seniors , and especially those in vulnerable groups , to engage with online health information and advice modalities ( eHIA ) and mobile health ( mHealth ) monitoring tools . Methods A mailed survey was conducted with age-sex stratified r and om sample s of English-speaking non-Hispanic white , African-American/black ( black ) , Hispanic/Latino ( Latino ) , Filipino-American ( Filipino ) , and Chinese-American ( Chinese ) Kaiser Permanente Northern California members who were aged 65–79 years . Respondent data were weighted to the study population for the cross-sectional analyses . Results Older seniors and black , Latino , and Filipino seniors have less access to digital tools , less experience performing a variety of online tasks , and are less likely to believe that they would be capable of going online for health information and advice compared to younger and white Non-Hispanic seniors . Consequently , they are also less likely to be interested in using eHIA modalities . Conclusions The same subgroups of seniors that have previously been shown to have higher prevalence of chronic conditions and greater difficulties with healthcare access are also less likely to adopt use of eHIA and  mHealth monitoring technologies . At the patient population level , this digital divide is important to take into account when planning health information and chronic disease management programs . At the individual patient level , to provide good patient-centered care , it is important for providers to assess rather than assume digital access , eHealth skills , and preferences prior to recommending use of web-based re sources and mHealth tools Introduction Rising burden of cardiovascular disease ( CVD ) and diabetes is a major challenge to the health system in India . Innovative approaches such as mobile phone technology ( mHealth ) for electronic decision support in delivering evidence -based and integrated care for hypertension , diabetes and comorbid depression have potential to transform the primary healthcare system . Methods and analysis mWellcare trial is a multicentre , cluster r and omised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India .  mWellcare system is an And roid-based mobile application design ed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records , sending alerts and reminders for follow-up and adherence to medication . We recruited a total of 3702 participants from 40 Community Health Centres ( CHCs ) , with ≥90 at each of the CHCs in the intervention and control ( enhanced care ) arms . The primary outcome is the difference in mean change ( from baseline to 1 year ) in systolic blood pressure and glycated haemoglobin ( HbA1c ) between the two treatment arms . The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose , total cholesterol , predicted 10-year risk of CVD , depression , smoking behaviour , body mass index and alcohol use between the two treatment arms and cost-effectiveness . Ethics and dissemination The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine . Findings will be disseminated widely through peer- review ed publications , conference presentations and other mechanisms . Trial registration mWellcare trial is registered with Clinical trial.gov ( Registration number NCT02480062 ; Pre- results ) and Clinical Trial Registry of India ( Registration number CTRI/2016/02/006641 ) . The current version of the protocol is Version 2 date d 19 October 2015 and the study sponsor is Public Health Foundation of India , Gurgaon , India ( www.phfi.org ) Background There is a need to find innovative approaches for translating best practice s for chronic disease care into daily primary care practice routines . Primary care plays a crucial role in the prevention and management of cardiovascular disease . There is , however , a substantive care gap , and many challenges exist in implementing evidence -based care . The Improved Delivery of Cardiovascular Care ( IDOCC ) project is a pragmatic trial design ed to improve the delivery of evidence -based care for the prevention and management of cardiovascular disease in primary care practice s using practice outreach facilitation . Methods The IDOCC project is a stepped-wedge cluster r and omized control trial in which Practice Outreach Facilitators work with primary care practice s to improve cardiovascular disease prevention and management for patients at highest risk . Primary care practice s in a large health region in Eastern Ontario , Canada , were eligible to participate . The intervention consists of regular monthly meetings with the Practice Outreach Facilitator over a one- to two-year period . Starting with audit and feedback , consensus building , and goal setting , the practice s are supported in changing practice behavior by incorporating chronic care model elements . These elements include ( a ) evidence -based decision support for providers , ( b ) delivery system re design for practice s , ( c ) enhanced self-management support tools provided to practice s to help them engage patients , and ( d ) increased community re source linkages for practice s to enhance referral of patients . The primary outcome is a composite score measured at the level of the patient to represent each practice 's adherence to evidence -based guidelines for cardiovascular care . Qualitative analysis of the Practice Outreach Facilitators ' written narratives of their ongoing practice interactions will be done . These textual analyses will add further insight into underst and ing critical factors impacting project implementation . Discussion This pragmatic , stepped-wedge r and omized controlled trial with both quantitative and process evaluations demonstrates innovative methods of implementing large-scale quality improvement and evidence -based approaches to care delivery . This is the first Canadian study to examine the impact of a large-scale multifaceted cardiovascular quality -improvement program in primary care . It is anticipated that through the evaluation of IDOCC , we will demonstrate an effective , practical , and sustainable means of improving the cardiovascular health of patients across Canada . Trial Registration Clinical Trials.gov : BACKGROUND Patients with end stage renal failure require dialysis and strict adherence to treatment plans to sustain life . However , non-adherence is a common and serious problem among patients with chronic kidney disease . There is a scarcity of studies in examining the effects of disease management programmes on patients with chronic kidney disease . OBJECTIVES This paper examines whether the study group receiving the disease management programme  have better improvement than the control group , comparing outcomes at baseline ( O1 ) , at 7 weeks at the completion of the programme ( O2 ) and at 13 weeks ( O3 ) . METHODS This is a r and omized controlled trial . The outcome measures were non-adherence in diet , fluid , dialysis and medication , quality of life , satisfaction , symptom control , complication control and health service utilisation . RESULTS There was no significant difference between the control and study group for the baseline measures , except for sleep . Significant differences ( p<0.05 ) were found between the control and study group at O2 in the outcome measures of diet degree non-adherence , sleep , symptom , staff encouragement , overall health and satisfaction . Sustained effects at O3 were noted in the outcome measures of continuous ambulatory peritoneal dialysis ( CAPD ) non-adherence degree , sleep , symptom , and effect of kidney disease . CONCLUSIONS Many studies exploring chronic disease management have neglected the group with end stage renal failure and this study fills this gap . This study has employed an innovative model of skill mix using specialist and general nurses and demonstrated patient improvement in diet non-adherence , CAPD non-adherence , aspects of quality of life and satisfaction with care . Re design ing chronic disease management programmes helps to optimize the use of different levels of skills and re sources to bring about positive outcomes Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency . After a r and omized controlled trial of a multilingual automated telephone self-management support program ( ATSM ) improved patient-centered dimensions of diabetes care in safety net clinics , we collaborated with a nonprofit Medicaid managed care plan to translate research into practice , offering ATSM as a covered benefit and augmenting ATSM to promote medication activation . This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project ( SMARTSteps ) . Methods / Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English , Cantonese , or Spanish and receive care at 4 publicly-funded clinics . Through language -stratified r and omization , participants were assigned to four intervention statuses : SMARTSteps-ONLY , SMARTSteps-PLUS , or wait-list for either intervention . In addition to usual primary care , intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care , medication adherence , safety concerns , psychological issues , and preventive services . Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning . SMARTSteps-PLUS also included health coach calls to promote medication activation , adherence and intensification , if triggered by ATSM-reported non-adherence , refill non-adherence from pharmacy cl aims , or suboptimal cardiometabolic indicators . Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months . For participants who agreed to structured telephone interviews at baseline and 6 months ( n = 252 ) , primary outcomes will be changes in quality of life and functional status with secondary outcomes of 6-month changes in self-management behaviors/efficacy and patient-centered processes of care . We will also evaluate 6-month changes in cardiometabolic ( HbA1c , blood pressure , and LDL ) and utilization indicators for all participants . Discussion Outcomes will provide evidence regarding real-world implementation of ATSM within a Medicaid managed care plan serving safety net setting s. The evaluation trial will provide insight into translating and scaling up health information technology interventions for linguistically and culturally diverse vulnerable population s with chronic disease . Trial Registration Clinical Trials.gov : Background The efficacy of disease management programs in improving the outcome of heart failure patients remains uncertain and may vary across health systems . This study explores whether a countrywide disease management program is superior to usual care in reducing adverse health outcomes and improving well-being among community-dwelling adult patients with moderate-to-severe chronic heart failure who have universal access to advanced health-care services and technologies . Methods In this multicenter open-label trial , 1,360 patients recruited after hospitalization for heart failure exacerbation ( 38 % ) or from the community ( 62 % ) were r and omly assigned to either disease management or usual care . Disease management , delivered by multi-disciplinary teams , included coordination of care , patient education , monitoring disease symptoms and patient adherence to medication regimen , titration of drug therapy , and home tele-monitoring of body weight , blood pressure and heart rate . Patients assigned to usual care were treated by primary care practitioners and consultant cardiologists . The primary composite endpoint was the time elapsed till first hospital admission for heart failure exacerbation or death from any cause . Secondary endpoints included the number of all hospital admissions , health-related quality of life and depression during follow-up . Intention-to-treat comparisons between treatments were adjusted for baseline patient data and study center . Results During the follow-up , 388 ( 56.9 % ) patients assigned to disease management and 387 ( 57.1 % ) assigned to usual care had a primary endpoint event . The median ( range ) time elapsed until the primary endpoint event or end of study was 2.0 ( 0–5.0 ) years among patients assigned to disease management , and 1.8 ( 0–5.0 ) years among patients assigned to usual care ( adjusted hazard ratio , 0.908 ; 95 % confidence interval , 0.788 to 1.047 ) . Hospital admissions were mostly ( 70 % ) unrelated to heart failure . Patients assigned to disease management had a better health-related quality of life and a lower depression score during follow-up . Conclusions This comprehensive disease management intervention was not superior to usual care with respect to the primary composite endpoint , but it improved health-related quality of life and depression . A disease-centered approach may not suffice to make a significant impact on hospital admissions and mortality in patients with chronic heart failure who have universal access to health care . Clinical trial registration Clinical trials.gov identifier : NCT00533013 . Trial registration date : 9 August 2007 . Initial protocol release date : 20 September 2007 Context Few studies have evaluated whether health care assistants can improve care for depressed patients .  Contribution Patients who were r and omly assigned to receive telephone case management by health care assistants  reported slightly greater improvements in depression symptoms , better adherence to antidepressant therapies , and more favorable assessment s of the quality of their care than did patients r and omly assigned to receive usual care .  Implication Telephone case management facilitated by health care assistants may be a feasible mechanism for small primary care practice s to improve care of their patients with depression . The Editors Depression causes a substantial disease burden ( 1 ) and is responsible for annual health care costs of about $ 83.1 billion in the United States ( 2 , 3 ) . Most patients with depression are treated in primary care ( 46 ) . Collaborative care can improve depression outcomes by providing decision support and clinical information for family physicians , as well as self-management support and follow-up for patients . However , evidence regarding collaborative depression care stems mostly from academic or managed care setting s in the United States ( 711 ) . In these trials , family physicians generally relied on mental health case managers and decision support from mental health specialists ( 12 ) . Case management is a patient-centered element of collaborative care that may be effective in primary care ( 13 ) . It comprises systematic tracking of patients , support for continuing the treatment , and taking action in the case of nonadherence or lack of improvement ( 14 ) . Collaborative depression care has generally yielded positive results in diverse primary care setting s ( 7 ) . The IMPACT ( Improving MoodPromoting Access to Collaborative Treatment ) trial found that care managers who were supervised by psychiatrists and who provided education and support for medication adherence reduced depression symptoms in older patients ( 15 ) . Dietrich and colleagues ( 16 ) found that telephone support , provided by a trained , central ly based mental health care manager who was supervised by a psychiatrist , improved depression symptoms . Dobscha and colleagues ( 17 ) evaluated a primary care decision-support team for depression ( comprising a psychiatrist and a mental health nurse ) and found improved care processes but no differences in depression symptoms ( 17 ) , possibly because of less intensive follow-up of patients . Small , isolated primary care setting s often have limited re sources ( 18 ) . In the United States , 26 % of primary care practice s are solo practice s or 2-person partnerships , in which extensive collaborative models would be difficult to implement , and 22 % are located in rural areas with limited access to mental health specialists ( 19 ) . Health care assistants are established professionals in primary care setting s. They have less training than U.S. physician assistants or nurse practitioners , who provide first-contact care , and need not be college graduates ( 20 ) . In Germany , health care assistants have 3 years of on-the-job training . They are mainly responsible for administrative tasks in general practice but provide basic clinical procedures ( 21 ) . Health care assistants are a potentially important re source for enhancing patient care in primary care setting s ( 20 ) . Our aim was to evaluate whether case management by a practice -based health care assistant can reduce depression symptoms and improve the process of care for patients with major depression in small primary care practice s. Methods We design ed a pragmatic , cluster r and omized , controlled trial that used practice as the unit of r and omization to avoid contamination ( 22 ) . The institutional review board of Goethe University Frankfurt am Main , Frankfurt am Main , Germany , approved the study protocol on 25 April 2005 ( 23 ) . We used written consent procedures for family physicians and patients . We recruited practice s between February 2005 and May 2005 and patients between May 2005 and July 2006 . We carried out the intervention between June 2005 and August 2007 . We completed the last follow-up for study patients in September 2007 . Setting and Participants After calculating the sample size ( 24 ) , we informed all 1600 family physicians registered with the medical association of the state of Hesse , Germany ( m and atory registration ) , about the trial and invited them by mail to participate in information meetings . As the registration list presents only names and addresses , we checked inclusion criteria only for those who participated in the meetings . We stopped recruiting when 74 practice s had enrolled , even though more practice s were interested in participating . Inclusion criteria for the practice s were acceptance of all major health plans ( 90 % of patients are covered by this type of insurance ) ( 25 ) ; provision of a primary care service , according to the definition of Starfield and colleagues ( 26 ) ; and management by a family physician . Patients were screened on special date s and referred to the trial by the family physician in the primary care practice . Inclusion criteria for patients were diagnosis of major depression with indication for any antidepressive treatment , age 18 to 80 years , access to a private telephone , ability to give informed consent , and ability to communicate in German . The diagnosis of major depression was based on a score of more than 9 points and a categorical diagnosis in the Patient Health Question naire-9 ( PHQ-9 ) ( 27 ) , and was confirmed by the family physician by using the checklists in the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , and International Classification of Diseases , Tenth Edition . New patients were double-screened with the same procedure within 2 weeks . Exclusion criteria were confirmed pregnancy , severe alcohol or illicit drug consumption , or acute suicidal ideation assessed by the family physician . R and omization and Interventions The data safety and monitoring board stratified the practice s according to the size of the city and performed computer-based r and omization . Patient r and om assignment status was nested within the practice status . The data safety and monitoring board was responsible for allocation concealment by keeping the r and omization results in a secure data base . Because of the practice staff training required for the behavioral intervention , patients , health care assistants , family physicians , and research ers were not blinded to assignment once the trial was started . We design ed our case management intervention in accordance with the Chronic Care Model ( 28 , 29 ) , which emphasizes proactive support for the patient by the entire practice team . We trained 1 health care assistant from each practice assigned to the intervention group in 2 workshops ( an 11-hour and a 6-hour workshop ) . This interactive training included information on depression , communication skills , telephone monitoring , and behavioral activation for the patient ( 3032 ) . The health care assistants contacted their patients by telephone twice a week in the first month and than once a month for the following 11 months . They monitored depression symptoms and adherence to medication by using the Depression Monitoring List ( 33 ) . Health care assistants also encouraged patients to follow self-management activities , such as medication adherence and activation for pleasant or social activities . The assistants provided this information to the family physician in a structured report that stratified the urgency of the contact by a robot scheme . Family physicians in both the intervention and control groups received training on evidence -based depression treatment guidelines ( 34 ) . During the trial , other forms of disease or case management programs were uncommon in Germany ( 35 ) . No study practice carried out case management for any other diseases . Outcomes and Follow-up Self-rating question naires were h and ed out to the patients at baseline and at 6 and 12 months after baseline . Patients filled in the question naires at home and sent them back to the practice . We collected the question naires in the practice s and collected data from patient records ( number of family physician and specialist contacts , hospitalization , and prescribed medication ) . Research staff carried out data input and management ( 36 ) . Serious adverse events were reported to the data safety and monitoring board . Clinical Outcomes The primary outcome was depression symptoms , which we assessed by using the primary carevali date d PHQ-9 ( 37 ) . Each item is scored from 0 ( not at all ) to 3 ( nearly every day ) , for a total score that ranges from 0 to 27 ( high scores indicate more severe depression ) . We assessed response ( 50 % improvement in PHQ-9 score ) and remission status ( PHQ-9 score<5 ) as secondary outcomes . We also report data for the following secondary outcomes : quality of life , patient assessment of chronic illness care , and medication adherence . We measured health-related quality of life by using the  Medical Outcomes Study Short Form 36 ( SF-36 ) ( 38 , 39 ) and the  EuroQol-5D  ( 40 ) . The SF-36 allows the calculation of scores for physical health and mental health ( range , 0 to 100 ; higher scores indicate better status ) . The EuroQol-5D is a generic instrument that measures health-related quality of life with a visual analogue scale ( range , 0 to 100 ; higher ratings indicate higher quality of life ) . We determined the number of physical comorbid conditions by counting the documented diagnoses from different diagnostic groups listed in the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , and International Classification of Diseases , Tenth Edition , excluding all psychiatric diagnoses in the patient record . We assessed severity of chronic physical diseases by using the Chronic Disease Score , on the basis of prescription data from the patient record ( 41 ) . Process-of-Care Outcomes We assessed the number of family physician and mental health specialist contacts , as well as prescriptions for Objective The aim of this study was to assess the feasibility and preliminary outcomes of a medication self-management platform for chronically ill patients , Medplan . Methods We performed a 6-month single-arm prospect i ve pre-post intervention study of patients receiving treatment for hypertension and /or dyslipidemia and /or heart failure and /or human immunodeficiency virus infection . During the pre-intervention phase , participants were followed according to their usual care ; during the intervention phase , they used Medplan . We evaluated adherence , health outcomes , healthcare re sources and measured the satisfaction of patients and health care professionals . Results The study population comprised 42 patients . No differences were found in adherence to medication measured by proportion of days covered with medication ( PDC ) . However , when adherence was measured using the SMAQ , the percentage of adherent patients improved during the intervention phase ( p < 0.05 ) , and the number of days with missed doses decreased ( p < 0.05 ) . Adherence measured using the Medplan app showed poor concordance with PDC . No differences were found in health outcomes or in the use of health care re sources during the study period . The mean satisfaction score for Medplan was 7.2 ± 2.7 out of 10 among patients and 7.3 ± 1.7 among health care professionals . In fact , 71.4 % of participants said they would recommend the app to a friend , and 88.1 % wanted to continue using it . Conclusion The Medplan platform proved to be feasible and was well accepted by its users . However , its impact on adherence differed depending on the assessment method . The lack of effect on PDC is mainly because patients were already good adherers at baseline . The study enabled us to vali date the platform in real patients using many different mobile devices and to identify potential barriers to scaling up the platform Background Chronic illness is a significant driver of the global burden of disease and associated health care costs . People living with severe chronic illness are heavy users of acute hospital services ; better coordination of their care could potentially improve health outcomes while reducing hospital use . The Care Navigation trial will evaluate an in-hospital coordinated care intervention on health service use and quality of life in chronically ill patients . Methods / Design A r and omised controlled trial in 500 chronically ill patients presenting to the emergency department of a hospital in Western Sydney , Australia . Participants have three or more hospital admissions within a previous 12 month period and either aged ≥70 years ; or aged ≥45 years and of Aboriginal or Torres Strait Isl and er descent ; or aged ≥ 16 with a diagnosis of a respiratory or cardiology related illness . Patients are r and omised to either the coordinated care program ( Care Navigation ) , or to usual care . The Care Navigation program consists of dedicated nurses who conduct patient risk assessment s , oversee patient nursing while in hospital , and guide development of a care plan for the management of chronic illness after being discharged from hospital . These nurses also book community appointments and liaise with general practitioners . The main outcome variables are the number of emergency department re-presentations and hospital readmissions , and quality of life during a 24 month follow-up . Secondary outcomes are length of hospital stay , mortality , time to first hospital re-admission , time to first emergency department re-presentation , patient satisfaction , adherence to prescribed medications , amount and type of in-hospital referrals made for consultations and diagnostic testing , and the number and type of community health referrals . A process evaluation and economic analysis will be conducted alongside the r and omised trial . Discussion A trial of in-hospital care coordination may support recent evidence that engaging primary health services in care plans linked to multidisciplinary team support improves patient outcomes and reduces costs to the health system . This will inform local , national and international health policy . Trial registration Australia New Zeal and Clinical Trials Registry Background Atrial fibrillation is a major public health problem and is the most common cardiac arrhythmia , affecting an estimated 2.7 million Americans . The true prevalence of atrial fibrillation is likely underestimated because episodes are often sporadic ; therefore , it is challenging to detect and record an occurrence in a “ real world ” setting . To date , mobile health tools that promote earlier detection and treatment of atrial fibrillation and improvement in self-management behaviors and knowledge have not been evaluated . This study will be the first to address the epidemic problem of atrial fibrillation with a novel approach utilizing advancements in mobile health electrocardiogram technology to empower patients to actively engage in their healthcare and to evaluate impact on quality of life and quality -adjusted life years . Furthermore , sending a daily electrocardiogram transmission , coupled with receiving educational and motivational text messages aim ed at promoting self-management and a healthy lifestyle may improve the management of chronic cardiovascular conditions ( e.g. , hypertension , diabetes , heart failure , etc . ) . Therefore , we are currently conducting a r and omized controlled trial to assess the efficacy of a mobile health intervention , iPhone ® Helping Evaluate Atrial fibrillation Rhythm through Technology ( iHEART ) versus usual cardiac care . Methods The iHEART study is a single center , prospect i ve , r and omized controlled trial . A total of 300 participants with a recent history of atrial fibrillation will be enrolled . Participants will be r and omized 1:1 to receive the iHEART intervention , receiving an iPhone ® equipped with an AliveCor ® Mobile ECG and accompanying Kardia application and behavioral altering motivational text messages or usual cardiac care for 6 months . Discussion This will be the first study to investigate the utility of a mobile health intervention in a “ real world ” setting . We will evaluate the ability of the iHEART intervention to improve the detection and treatment of recurrent atrial fibrillation and assess the intervention 's impact on improving clinical outcomes , quality of life , quality -adjusted life-years and disease-specific knowledge . Trial registration NCT02731326 ; Verified April BACKGROUND Extensive uptake of mobile phones offers an unprecedented opportunity to improve global healthcare delivery , especially among underserved population s.  Mobile health ( mHealth ) has been increasingly recognized as a promising approach to addressing challenges in global maternal-child health and may play an important role in accelerating progress towards improved outcomes . However , more evidence guiding development of mHealth interventions is needed . The current study explores factors that may support or hinder adoption and use of a proposed mHealth intervention to improve caregiver home management of common childhood illnesses in order to shape program development . METHODS Elicitation interviews were conducted with a convenience sample of 25 mothers recruited from a larger cluster-r and omized survey sample in the Cono Norte region of Arequipa , Peru . Interview data were analyzed in Spanish to preserve important cultural nuances . RESULTS Thematic analysis revealed potential facilitators of and barriers to uptake of the proposed mHealth program . Potential facilitators of caregiver participation include opportunity to engage in two-way communication with healthcare providers , development of instrumental and support knowledge to care for sick children , and healthcare challenges faced in a re source -poor community . Potential barriers include preference for in-person healthcare visits , program cost , text messaging abilities , and concern around program legitimacy . CONCLUSIONS This study underscores the potential for mHealth to improve global healthcare delivery in the area of maternal-child health . It demonstrates that mHealth interventions can meet the needs of vulnerable population s by offering novel approaches to promoting evidence -based care . This in-depth underst and ing of factors that may influence participation and use of this proposed mHealth program will help shape development of the intervention in this community The purpose of this qualitative study was to elicit information on why a  promotora ( or , community health worker ( CHW ) ) increased adherence to chronic disease screening among women along the U.S.-Mexico border . After completion of the intervention , women and clinic staff who participated in the promotora phase of a r and omized , controlled study answered structured , open-ended question naires . Clinicians from two non-participating clinics were also interviewed . Content analysis found that the promotora 's roles included health education and the facilitation of routine and follow-up care . Clients appreciated the promotora 's socio-cultural characteristics , as well as her personal skills and qualities , and described her as a trained , natural helper whose personalized support removed barriers to health care and helped women to take care of themselves . Most clinicians recommended working with a CHW to increase adherence to chronic disease prevention practice s. A CHW can play a crucial role on a health care team and interventions should tap into this re source Background Self-management is seen as a primary mechanism to support the optimization of care for people with chronic diseases such as symptomatic vascular disease . There are no established and evidence -based stroke-specific chronic disease self-management programs . Our aim is to evaluate whether a stroke-specific program is safe and feasible as part of a Phase II r and omized-controlled clinical trial . Methods Stroke survivors are recruited from a variety of sources including : hospital stroke services , local paper advertisements . Stroke South Australia newsletter ( volunteer peer support organization ) , Divisions of General Practice , and community service providers across Adelaide , South Australia . Subjects are invited to participate in a multi-center , single-blind , r and omized , controlled trial . Eligible participants are r and omized to either ; st and ard care , st and ard care plus a six week generic chronic condition self-management group education program , or , st and ard care plus an eight week stroke specific self-management education group program .  Interventions are conducted after discharge from hospital . Participants are assessed at baseline , immediate post intervention and six months . Study Outcomes The primary outcome measures determine study feasibility and safety , measuring , recruitment , participation , compliance and adverse events . Secondary outcomes include : positive and active engagement in life measured by the Health Education Impact Question naire , improvements in quality of life measured by the Assessment of Quality of Life instrument , improvements in mood measured by the Irritability , Depression and Anxiety Scale , health re source utilization measured by a participant held diary and safety . Conclusion The results of this study will determine whether a definitive Phase III efficacy trial is justified Background Asthma is a prevalent and costly disease result ing in reduced quality of life for a large proportion of individuals . Effective patient self-management is critical for improving health outcomes . However , key aspects of self-management such as self-monitoring of behaviours and symptoms , coupled with regular feedback from the health care team , are rarely addressed or integrated into ongoing care . Health information technology ( HIT ) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team , and access to their health information , presented in personalized ways that can alert them when there is a need for action . The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system , My Asthma Portal ( MAP ) , linked to a case-management system on asthma control , and asthma health-related quality of life . Methods The trial is a parallel multi-centered 2-arm pilot r and omized controlled trial . Participants are r and omly assigned to one of two conditions : a ) MAP and usual care ; or b )  usual care alone .  Individuals will be included if they are between 18 and 70 , have a confirmed asthma diagnosis , and their asthma is classified as not well controlled by their physician .  Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug data base , and asthma quality of life using the Mini Asthma Related Quality of Life Question naire . Power calculations indicated a needed total sample size of 80 subjects . Data are collected at baseline , 3 , 6 , and 9 months post r and omization . Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010 . Discussion Self-management support from the care team is critical for improving chronic disease outcomes . Given the high volume of patients and time constraints during clinical visits , primary care physicians have limited time to teach and reinforce use of proven self-management strategies . HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change . Trial Registration Current Controlled Trials IS RCT N34326236 Background Chronic congestive heart failure ( CHF ) is a complex disease with rising prevalence , compromised quality of life ( QoL ) , unplanned hospital admissions , high mortality and therefore high burden of illness . The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients ' health outcomes , although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations . It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner ( GP ) can improve patients ' QoL. Methods / Design HICMan is a r and omised controlled trial with patients as the unit of r and omisation . Aim is to evaluate a structured , st and ardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial . Patients from intervention group  receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse , who gives feedback to the GP upon urgency . Monitoring and screening address aspects of disease-specific self-management , (non)pharmacological adherence and psychosomatic and geriatric comorbidity . GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis ( data of baseline documentation ) .  Patients from control group receive usual care by their GPs , who were introduced to guideline -oriented management and a tailored health counselling concept . Main outcome measurement for patients ' QoL is the scale physical functioning of the SF-36 health question naire in a 12-month follow-up . Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy question naire ( KCCQ ) , depression and anxiety disorders ( PHQ-9 , GAD-7 ) , adherence ( EHFScBS and SANA ) , quality of care measured by an adapted version of the Patient Chronic Illness Assessment of Care question naire ( PACIC ) and NT-proBNP . In addition , comprehensive clinical data are collected about health status , comorbidity , medication and health care utilisation . Discussion As the targeted patient group is mostly cared for and treated by GPs , a comprehensive primary care-based guideline implementation including somatic , psychosomatic and organisational aspects of the delivery of care ( HICMAn ) is a promising intervention applying proven strategies for optimal care . Trial registration Current Controlled Trials IS RCT N30822978 BACKGROUND Mobile Health technology for the management of patients with atrial fibrillation is unknown . METHODS The simple mobile AF ( mAF ) App was design ed to incorporate clinical decision-support tools ( CHA2DS2-VASc [ Congestive heart failure , Hypertension , Age ≥75 years , Diabetes Mellitus , Prior Stroke or TIA , Vascular disease , Age 65 - 74 years , Sex category ] , HAS-BLED [ Hypertension , Abnormal renal/liver function , Stroke , Bleeding history or predisposition , Labile INR , Elderly , Drugs/alcohol concomitantly ] , SAMe-TT2R2 [ Sex , Age < 60 years , Medical history , Treatment , Tobacco use , Race ] scores ) , educational material s , and patient involvement strategies with self-care protocol s and structured follow-up . Patients with atrial fibrillation were r and omized into 2 groups ( mAF App vs usual care ) in a cluster r and omized design pilot study . Patients ' knowledge , quality of life , drug adherence , and anticoagulation satisfaction were evaluated at baseline , 1 month , and 3 months . Usability , feasibility , and acceptability of the mAF App were assessed at 1 month . RESULTS A total of 113 patients were r and omized to mAF App intervention ( mean age , 67.4 years ; 57.5 % were male ; mean follow-up , 69 days ) , and 96 patients were r and omized to usual care ( mean age , 70.9 years ; 55.2 % were male ; mean follow-up , 95 days ) . More than 90 % of patients reported that the mAF App was easy , user-friendly , helpful , and associated with significant improvements in knowledge compared with the usual care arm ( P values for trend < .05 ) . Drug adherence and anticoagulant satisfaction were significantly better with the mAF App versus usual care ( all P < .05 ) . Quality of life scores were significantly increased in the mAF App arm versus usual care , with anxiety and depression reduced ( all P < .05 ) . CONCLUSIONS The pilot mAFA Trial is the first prospect i ve r and omized trial of Mobile Health technology in patients with atrial fibrillation , demonstrating that the mAF App , integrating clinical decision support , education , and patient-involvement strategies , significantly improved knowledge , drug adherence , quality of life , and anticoagulation satisfaction Integration of clinical pharmacists in patient care may offer increased access to health care and improved patient outcomes . Recently introduced legislation would establish pharmacists as health care providers and enable coverage of pharmacists ' services through Medicare Part B in medically underserved communities ( 1 , 2 ) . Pharmaceutical care involves pharmacist collaboration with health team members to optimize therapeutic outcomes ( 3 ) . Since 1995 , the Department of Veterans Affairs has allowed clinical pharmacy specialists an exp and ed scope of practice , with independent prescribing privileges ( 4 ) . The scope of practice for clinical pharmacy specialists includes pharmaceutical care or comprehensive medication management for patients with chronic diseases in addition to less complex services , such as counseling patients on medications or responding to questions about drug information . A 2014 systematic review evaluated outpatient medication therapy management interventions ( 5 ) . Study inclusion criteria required that interventions have , at minimum , 3 elements : comprehensive medication review ; patient-directed education and counseling ; and coordination of care , including prescriber-directed interventions . The research ers concluded that evidence was insufficient for health outcomes , although interventions may reduce the frequency of some medication-related problems and decrease some health care use and costs . We determined the effectiveness and harms of pharmacist-led chronic disease management compared with usual care for community-dwelling adults . Chronic disease management is typically a multicomponent intervention ( Figure 1 ) , and we required that the pharmacist take a lead role in at least 1 component . Studies where the pharmacist was a collaborator on a Patient Aligned Care Team or similar care strategy were not included . This report summarizes findings of a Department of Veterans Affairs Evidence -based Synthesis Program review ( available at www.hsrd . research .va.gov/publications/esp ) . Figure 1 . Components of pharmacist-led chronic disease management . * Follow-up after prescription for medication effectiveness and safety and drug-related problems . Includes medication reconciliation . The pharmacist provides immunization , which was not an outcome of interest . Facilitate access to other health care professionals and provide education about disease , lifestyle changes , aspirin therapy , and tobacco cessation . Supplement . Study Protocol Methods We developed a protocol for the review with input from content experts and method ologists . The protocol was not registered but was available for comment during review development . Data Sources and Search es We search ed MEDLINE ( Ovid ) , CINAHL , the Cochrane Library , and International Pharmaceutical Abstract s from 1995 through February 2016 for English- language literature ( Appendix Table 1 ) . We obtained additional articles by h and - search ing reference lists of systematic review s and other articles and from peer- review ers . Appendix Table 1 . Search Strategy for MEDLINE ( Ovid ) Study Selection We focused on chronic disease management for out patients in health care facilities , excluding retail pharmacies . We emphasized patient- or health system-centered outcomes but also addressed intermediate measures . MEDLINE abstract s were review ed for eligibility by 2 research ers ; abstract s from other data bases were review ed by a single research er . Full-text articles of studies identified as potentially eligible on the basis of abstract review were obtained for further review . Each article was independently review ed by 2 investigators or research associates . We included studies of any design that had a control group , evaluated outpatient adults with or at risk for a chronic disease , tested an intervention where the pharmacist was responsible for a distinct component of patient care , and were set in U.S. health care facilities . We excluded studies that did not involve interventions intended to manage or prevent 1 or more chronic diseases and studies of anticoagulation clinics because pharmacist management is considered st and ard care in those setting s. The Appendix Figure shows the reasons for study exclusion at full-text review . Appendix Figure . Summary of evidence search and selection . CCT = controlled clinical trial ; IPA = International Pharmaceutical Abstract s ; RCT = r and omized , controlled trial . Data Extraction and Quality Assessment Study data were extracted by one investigator and independently verified by a second . Our main outcomes of interest were clinical events , mortality , patient satisfaction , health care utilization ( including urgent care or emergency department visits and hospitalizations ) , medication adherence , and goal attainment ( Appendix Table 2 ) We also assessed access to care , quality of life , drug-related problems , and costs . We assessed risk of bias ( low , medium , or high ) for individual studies on the basis of sequence generation , allocation concealment , confounding ( for nonr and omized studies ) , blinding , and incomplete or selective outcome reportinga modification of the Cochrane approach ( 6 ) ( Appendix Table 2 ) . Appendix Table 2 . Evidence From Included Studies Appendix Table 2Continued Appendix Table 2Continued Appendix Table 2Continued Data Synthesis and Analysis We grouped studies by disease state and described and qualitatively compared the characteristics and findings of included studies . We rated the overall strength of the body of evidence across disease states for clinical events , patient satisfaction , target goal attainment , urgent care or emergency department visits and hospitalizations , and medication adherence by using the method of Owens and colleagues ( 7 ) . Two trained review ers grade d the strength of evidence regarding the outcomes as high , moderate , low , or insufficient on the basis of risk of bias , consistency , precision , and directness . We resolved discrepancies in risk of bias and strength of evidence ratings by discussion with final determination arrived through consensus that included the principal investigator . Most findings are summarized in narrative form , but we pooled results if studies were r and omized ( noncluster ) trials and enrolled participants and outcome measures were similar within each disease condition . DerSimonianLaird r and om-effects models were used to calculate pooled risk ratios ( RRs ) and 95 % CIs . We assessed statistical heterogeneity by using the I 2 statistic ( 75 % indicates substantial heterogeneity ) ( 8) . Role of the Funding Source The Department of Veterans Affairs , Veterans Health Administration , Office of Research and Development , Quality Enhancement Research Initiative assigned the topic and review ed the key questions but was not involved in data collection , analysis , or manuscript preparation or su bmi ssion . Results Search results are shown in the Appendix Figure . We included 72 articles representing 63 studies ( 40 r and omized , controlled trials [ RCTs ] ) with 65 unique study population s ( 940 - 4172 - 7381 ) . We grouped studies by disease state of the population and study characteristics ( Table 1 ) . Most studies were conducted in primary care setting s ( community-based or university-affiliated ) , but a few were in specialty clinics ( cardiology , nephrology , endocrinology ) . Interventions were typically delivered by pharmacists in person or with a mix of in-person and remote visits ( in 89 % of studies ) over multiple sessions ( 89 % ) . However , interventions varied in composition , delivery mode , and intensity , making it difficult to identify important intervention characteristics . Fifty-two studies were judged as low or medium risk of bias . Table 1 . Summary of Included Studies , by Disease State and Study Characteristics * Studies were generally short term ( 12 months ) and had small sample s. They mainly assessed intermediate outcomes , such as blood pressure , cholesterol , or glucose goal attainment , in patients with hypertension , cardiovascular disease , or diabetes ( 45 of 65 unique studies ) . Goal attainment was listed as the primary study outcome in 23 unique studies . Clinical events were described in 15 unique studies and were the primary outcome in 2 of those studies . Office visits , medication adherence or nonadherence , hospitalizations , patient satisfaction , and health-related quality of life were noted in 26 , 27 , 20 , 19 , and 19 studies , respectively , but they rarely were the primary outcome . Additional study details are presented in Appendix Table 2 . Findings Across All Disease Conditions In 15 trials ( 12 RCTs ) reporting clinical events ( for example , hypotension or hypoglycemia requiring additional intervention ) , pharmacist-led care and usual care ( typically continuing a pre study visit schedule ) were generally similar ( Appendix Table 3 ) ( 12 , 14 , 1922 , 3437 , 59 , 62 , 64 , 71 , 75 , 77 ) Eight studies reported all-cause mortality  , of which 6 found similar mortality in the pharmacist-led care and control groups and 2 did not report significance ( 12 , 13 , 16 , 18 , 28 , 30 , 37 , 71 ) . One of these studies in patients with diabetes also reported no disease-related deaths ( 28 ) . However , of studies reporting clinical events or mortality , only 2 were design ed to assess clinical events ( 13 , 14 ) , outcomes were sporadically and inconsistently reported , and there were few events ( low strength of evidence ) ( Table 2 ) . Evidence was insufficient to evaluate the effect of pharmacist-led care on patient satisfaction ( overall and for each disease condition ) and limited reporting of quality -of-life outcomes . Compared with usual care , pharmacist-led care improved study -selected goal attainment ( typically for blood pressure , lipid , and glycemic goals ) . Strength of evidence was moderate , with consistent findings across disease conditions . Table 2 . Strength of Evidence , by Outcome Evaluated * Appendix Table 3 . Summary of Direction of Evidence For re source use outcomes , pharmacist-led care was similar to usual care for incidences or rates of office visits ( 26 studies ) , urgent care or Chronic obstructive pulmonary disease ( COPD ) is one of the more disabling diseases and the third cause of mortality worldwide . Self-management is considered an effective strategy for controlling and managing COPD . This review aims to summarise the available evidence on the effectiveness of COPD self-management in primary care setting s. Social Sciences , Citation Index , MEDLINE , CINAHL , Academic Search Complete and Scopus were search ed for r and omised controlled trials of COPD self-management in general practice between 2001 and 2018 . Ten r and omised controlled trials of COPD self-management trials conducted in primary care setting s were included in this review . The identified trials have recruited stable patients ; a majority having mild to moderate COPD . The trials implemented different types of interventions and measured improvements in knowledge , skills and behaviours of self-management , mental health , self-efficacy and endpoint outcomes such as hospitalisation and quality of life . The findings showed that COPD self-management trials had positive effects on COPD knowledge and improved self-management behaviours such as adherence to medication , physical activities and smoking cessation in some cases ; however , the effect of trials on hospitalisation rate , quality of life and healthcare utilisation were not conclusive . There was also not enough evidence to suggest that the trials were efficient in improving self-efficacy , a major driver of self-management behaviours . Primary care COPD self-management trials are efficient in improving surrogate outcomes such as knowledge of and adherence to self-management behaviours ; however , such improvements are less likely to be sustainable in the absence of self-efficacy . Future studies should also focus on improving endpoint self-management outcomes like hospitalisation rate and quality of life to benefit both patient and healthcare system Background Osteoarthritis ( OA ) of the knee is one of the leading causes of disability in the United States . One relatively new strategy that could be helpful in the management of OA is the use of mHealth technologies , as they can be used to increase physical activity and promote exercise , which are key components of knee OA management . Objective Currently , no published data on the use of a mHealth approach to comprehensively monitor physical activity in patients with OA are available , and similarly , no data on whether mHealth technologies can impact outcomes are available . Our objective is to evaluate the effectiveness of mHealth technology as part of a tailored , comprehensive management strategy for patients with knee OA . Methods The study will assess the impact of a smartphone app that integrates data from a wearable activity monitor ( thereby both encouraging changes in mobility as well as tracking them ) combined with education about the benefits of walking on patient mobility . The results from the intervention group will be compared with data from a control group of individuals who are given the same Arthritis Foundation literature regarding the benefits of walking and wearable activity monitors but who do not have access to the data from those monitors . Activity monitors will capture step count estimates and will compare those with patients ’ step goals , calories burned , and distance walked . Patients using the novel smartphone app will be able to enter information on their daily pain , mood , and sleep quality . The relationships among activity and pain , activity and mood , and sleep will be assessed , as will patient satisfaction with and adherence to the mobile app . Results We present information on an upcoming trial that will prospect ively assess the ability of a mobile app to improve mobility for knee OA patients who are treated with intra-articular hyaluronic acid . Conclusions We anticipate the results of this study will support the concept that mHealth technologies provide continuous , real-time feedback to patients with OA on their overall level of activity for a more proactive , personalized approach to treatment that may help modify behavior and assist with self-management through treatment support in the form of motivational messages and reminders BACKGROUND Chronically critically ill patients often have high costs of care and poor outcomes and thus might benefit from a disease management program . OBJECTIVES To evaluate how adding a disease management program to the usual care system affects outcomes after discharge from the hospital ( mortality , health-related quality of life , re source use ) in chronically critically ill patients . METHODS In a prospect i ve experimental design , 335 intensive care patients who received more than 3 days of mechanical ventilation at a university medical center were recruited . For 8 weeks after discharge , advanced practice nurses provided an intervention that focused on case management and interdisciplinary communication to patients in the experimental group . RESULTS A total of 74.0 % of the patients survived and completed the study . Significant predictors of death were age ( P = .001 ) , duration of mechanical ventilation ( P = .001 ) , and history of diabetes ( P = .04 ) . The disease management program did not have a significant impact on health-related quality of life ; however , a greater percentage of patients in the experimental group than in the control group had " improved " physical health-related quality of life at the end of the intervention period ( P = .02 ) . The only significant effect of the intervention was a reduction in the number of days of hospital readmission and thus a reduction in charges associated with readmission . CONCLUSION The intervention was not associated with significant changes in any outcomes other than duration of readmission , but the supportive care coordination program could be provided without increasing overall charges The prevalence of older Australians with multiple chronic diseases is increasing and now accounts for a large proportion of total health care utilisation . Chronic disease self-management support ( CDSMS ) has become a core service component of many community based health programs because it is considered a useful tool in improving population health outcomes and reducing the financial burden of chronic disease care . However , the evidence base to justify these support programs is limited , particularly for older people with multiple chronic diseases . We describe an ongoing trial examining the effectiveness of a particular CDSMS approach called the Flinders Program . The Flinders Program is a clinician-led generic self-management intervention that provides a set of tools and a structured process that enables health workers and patients to collaboratively assess self-management behaviours , identify problems , set goals , and develop individual care plans covering key self-care , medical , psychosocial and carer issues . A sample of 252 older Australians that have two or more chronic conditions will be r and omly assigned to receive either CDSMS or an attention control intervention ( health information only ) for 6 months . Outcomes will be assessed using self-reported health measures taken at baseline and post-intervention . This project will be the first comprehensive evaluation of CDSMS in this population . Findings are expected to guide consumers , clinicians and policymakers in the use of CDSMS , as well as facilitate prioritisation of public monies towards evidence -based services Background Mobile health ( mHealth ) has huge potential to deliver preventative health services . However , there is paucity of literature on theoretical constructs , technical , practical , and regulatory considerations that enable delivery of such services . Objectives The objective of this study was to outline the key considerations in the development of a text message-based mHealth program ; thus providing broad recommendations and guidance to future research ers design ing similar programs . Methods We describe the key considerations in design ing the intervention with respect to functionality , technical infrastructure , data management , software components , regulatory requirements , and operationalization . We also illustrate some of the potential issues and decision points utilizing our experience of developing text message ( short message service , SMS ) management systems to support 2 large r and omized controlled trials : TEXT messages to improve MEDication adherence & Secondary prevention ( TEXTMEDS ) and Tobacco , EXercise and dieT MEssages ( TEXT ME  ) . Results The steps identified in the development process were : ( 1 ) background research and development of the text message bank based on scientific evidence and disease-specific guidelines , ( 2 ) pilot testing with target audience and incorporating feedback , ( 3 ) software-hardware customization to enable delivery of complex personalized programs using prespecified algorithms , and ( 4 ) legal and regulatory considerations . Additional considerations in developing text message management systems include : balancing the use of customized versus preexisting software systems , the level of automation versus need for human inputs , monitoring , ensuring data security , interface flexibility , and the ability for upscaling . Conclusions A merging of expertise in clinical and behavioral sciences , health and research data management systems , software engineering , and mobile phone regulatory requirements is essential to develop a platform to deliver and manage support programs to hundreds of participants simultaneously as in TEXT ME and TEXTMEDS trials . This research provides broad principles that may assist other research ers in developing mHealth programs OBJECTIVES To review the literature on comorbid depression and diabetes ( DM/D ) and present a conceptual framework for integrating depression management with diabetes care in a managed care environment . STUDY DESIGN Literature review . RESULTS Depression affects diabetes management by 1 ) directly affecting patients ' health-related quality of life , 2 ) reducing physical activity levels , 3 ) limiting adherence to self-care regimens , and 4 ) impairing patients ' ability to communicate effectively with clinicians . Small r and omized trials suggest that both antidepressant medication and cognitive behavioral therapies ( CBTs ) or related approaches may improve not only DM/D patients ' depressive symptoms , but their physical health as well . CONCLUSIONS An effective DM/D management strategy should include the following elements : 1 ) systematic identification of DM/D patients and quality -of-care review s , 2 ) proactive patient monitoring between outpatient encounters , 3 ) intensive efforts to coordinate treatment across providers , 4 ) increased access to CBT or related therapies addressing patients ' depressive symptoms and diabetes self care , and 5 ) an emphasis on promoting physical activity to address both depressive symptoms and physiologic dysregulation . The conceptual framework developed for the care of DM/D patients offers general insights into the management of patients with multiple chronic medical BACKGROUND Medications can improve the functioning and health-related quality of life of patients with chronic heart failure ( CHF ) and reduce morbidity , mortality , and costs of treatment . However , patients may not adhere to therapy . Patients with complex medication regimens and low health literacy are at risk for nonadherence . OBJECTIVE The primary goal of this project is to develop and assess a multilevel pharmacy-based program to improve patient medication adherence and health outcomes for elderly CHF patients with low health literacy . METHODS In this 4-year , controlled trial , patients aged 50 years with a diagnosis of CHF who are being treated at Wishard Health Services ( Indianapolis , Indiana ) are r and omly assigned to  pharmacist intervention or usual care . Intervention patients receive 9 months of pharmacist support and 3 months of postintervention follow-up . The intervention involves a pharmacist providing verbal and written education , icon-based labeling of medication containers , and therapeutic monitoring . The pharmacist identifies patients ' barriers to appropriate drug use , coaches them on overcoming these barriers , and coordinates medication use issues with their primary care providers . Daily up date s of relevant monitoring data are delivered via an electronic medical record system and stored in a personal computer system design ed to support pharmacist monitoring and facilitate documentation of interventions . To measure medication adherence objective ly , electronic monitoring lids are used on all CHF medications for patients in both study groups . Other assessment s include self-reported medication adherence , results of echocardiography ( eg , ejection fraction ) , brain natriuretic peptide concentrations , and health-related quality of life . Health services utilization , refill adherence , and cost data derive from electronic medical records . After completion of this study , the data can be used to assess the effectiveness and cost-effectiveness of our intervention . RESULTS One hundred twenty-two patients have been assigned to receive the intervention and 192 to receive usual care . CONCLUSIONS Our study aims to improve patients ' knowledge and self-management of their medication and to improve medication monitoring in a multilevel pharmacy-based intervention . By doing so , we intend that the intervention will improve the health outcomes of elderly patients with CHF BACKGROUND Hypertension is a major contributor to the health and economic burden imposed by stroke , heart disease , and renal insufficiency . Antihypertensives can prevent many of the harmful effects of elevated blood pressure , but medication nonadherence is a known barrier to the effectiveness of these treatments . Smartphone-based applications that remind patients to take their medications , provide education , and allow for social interactions between individuals with similar health concerns have been widely advocated as a strategy to improve adherence but have not been subject to rigorous testing . METHODS / DESIGN The MedISAFE-BP study is a prospect i ve , r and omized control trial design ed to evaluate the impact on blood pressure and medication adherence of an mhealth application ( Medisafe ) .  Four hundred thirteen patients with uncontrolled hypertension have been enrolled and r and omized in a 1:1 fashion to usual care or to the use of the Medisafe mhealth platform  . Patients will be followed up for 12 weeks and the trial 's co- primary outcomes will be change in systolic blood pressure and self-reported medication adherence . DISCUSSION The MedISAFE-BP trial is the first study to rigorously evaluate an mhealth application 's effect on blood pressure and medication adherence . The results will inform the potential effectiveness of this simple system in improving cardiovascular disease risk factors and clinical outcomes 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 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 ) Abstract Background : It is well established in the literature that regular participation in physical activity is effective for chronic disease management and prevention . Remote monitoring technologies ( ie , mHealth ) hold promise for engaging patients in self-management of many chronic diseases . The purpose of this study was to test the effectiveness of an mHealth study with tailored physical activity prescription targeting changes in various intensities of physical activity ( eg , exercise , sedentary behavior , or both ) for improving physiological and behavioral markers of lifestyle-related disease risk . Methods : Forty-five older adults ( aged 55–75 years ; mean age 63 ± 5 years ) were r and omly assigned to receive a personal activity program targeting changes to either daily exercise , sedentary behavior , or both . All participants received an mHealth technology kit including smartphone , blood pressure monitor , glucometer , and pedometer . Participants engaged in physical activity programming at home during the 12-week intervention period and su bmi tted physical activity ( steps/day ) , blood pressure ( mm Hg ) , body weight ( kg ) , and blood glucose ( mmol/L ) measures remotely using study -provided devices . Results : There were no differences between groups at baseline ( P > 0.05 ) . The intervention had a significant effect ( F(10 488 ) = 2.947 , P = 0.001 , ηP2 = 0.057 ) , with similar changes across all groups for physical activity , body weight , and blood pressure ( P > 0.05 ) . Changes in blood glucose were significantly different between groups , with groups prescribed high-intensity activity ( ie , exercise ) demonstrating greater reductions in blood glucose than the group prescribed changes to sedentary behavior alone ( P < 0.05 ) . Conclusions : Findings demonstrate the utility of pairing mHealth technologies with activity prescription for prevention of lifestyle-related chronic diseases among an at-risk group of older men and women . Results support the novel approach of prescribing changes to sedentary behaviors ( alone , and in conjunction with exercise ) to reduce risk of developing lifestyle-related chronic conditions 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 UNLABELLED In August 2008 , the Medical Advisory Secretariat ( MAS ) presented a vignette to the Ontario Health Technology Advisory Committee ( OHTAC ) on a proposed targeted health care delivery model for chronic care . The proposed model was defined as multidisciplinary , ambulatory , community-based care that bridged the gap between primary and tertiary care , and was intended for individuals with a chronic disease who were at risk of a hospital admission or emergency department visit . The goals of this care model were thought to include : the prevention of emergency department visits , a reduction in hospital admissions and re-admissions , facilitation of earlier hospital discharge , a reduction or delay in long-term care admissions , and an improvement in mortality and other disease-specific patient outcomes .OHTAC approved the development of an evidence -based assessment to determine the effectiveness of specialized community based care for the management of  heart failure , Type 2 diabetes and chronic wounds .  PLEASE VISIT THE MEDICAL ADVISORY SECRETARIAT WEB SITE AT : www.health.gov.on.ca/ohtas to review the following reports associated with the Specialized Multidisciplinary Community-Based care series . Specialized multidisciplinary community-based care series : a summary of evidence -based analysesCommunity-based care for the specialized management of heart failure : an evidence -based analysis Community-based care for chronic wound management : an evidence -based analysis Please note that the evidence -based analysis of specialized community-based care for the management of diabetes titled : " Community-based care for the management of type 2 diabetes : an evidence -based analysis " has been published as part of the Diabetes Strategy Evidence Platform at this URL : http://www.health.gov.on.ca/english/providers/program/mas/tech/ohtas/tech_diabetes_20091020.htmlPLEASE VISIT THE TORONTO HEALTH ECONOMICS AND TECHNOLOGY ASSESSMENT COLLABORATIVE WEB SITE AT : http://theta.utoronto.ca/papers/MAS_CHF_Clinics_Report.pdf to review the following economic project associated with this series : Community-based Care for the specialized management of heart failure : a cost-effectiveness and budget impact analysis . OBJECTIVE The objective of this evidence -based review is to determine the effectiveness of a multidisciplinary wound care team for the management of chronic wounds . CLINICAL NEED CONDITION AND TARGET POPULATION Chronic wounds develop from various aetiologies including pressure , diabetes , venous pathology , and surgery . A pressure ulcer is defined as a localized injury to the skin/ and or underlying tissue occurring most often over a bony prominence and caused , alone or in combination , by pressure , shear , or friction . Up to three fifths of venous leg ulcers are due to venous aetiology . Approximately 1.5 million Ontarians will sustain a pressure ulcer , 111,000 will develop a diabetic foot ulcer , and between 80,000 and 130,000 will develop a venous leg ulcer . Up to 65 % of those afflicted by chronic leg ulcers report experiencing decreased quality of life , restricted mobility , anxiety , depression , and /or severe or continuous pain . MULTIDISCIPLINARY WOUND CARE TEAMS : The term ' multidisciplinary ' refers to multiple disciplines on a team and ' interdisciplinary ' to such a team functioning in a coordinated and collaborative manner . There is general consensus that a group of multidisciplinary professionals is necessary for optimum specialist management of chronic wounds stemming from all aetiologies . However , there is little evidence to guide the decision of which professionals might be needed form an optimal wound care team . EVIDENCE -BASED ANALYSIS METHODS LITERATURE SEARCH A literature search was performed on July 7 , 2009 using OVID MEDLINE , MEDLINE In-Process and Other Non-Indexed Citations , OVID EMBASE , Wiley Cochrane , Centre for Review s and Dissemination/International Agency for Health Technology Assessment , and on July 13 , 2009 using the Cumulative Index to Nursing & Allied Health Literature ( CINAHL ) , and the International Agency for Health Technology Assessment ( INAHTA ) for studies pertaining to leg and foot ulcers . A similar literature search was conducted on July 29 ' 2009 for studies pertaining to pressure ulcers . Abstract s were review ed by a single review er and , for those studies meeting the eligibility criteria , full-text articles were obtained . Reference lists were also examined for any additional relevant studies not identified through the search . Articles with an unknown eligibility were review ed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established . INCLUSION CRITERIA R and omized controlled trials and Controlled clinical Trials ( CCT ) Systematic review with meta analysis Population includes persons with pressure ulcers ( anywhere ) and /or leg and foot ulcersThe intervention includes a multidisciplinary ( two or more disciplines ) wound care team . The control group does not receive care by a wound care team Studies published in the English language between 2004 and 2009 EXCLUSION CRITERIA : Single centre retrospective observational studies OUTCOMES OF INTEREST Proportion of persons and /or wounds completely healedTime to complete healing Quality of LifePain assessment SUMMARY OF FINDINGS Two studies met the inclusion and exclusion criteria , one a r and omized controlled trial ( RCT ) , the other a CCT using a before and after study design . There was variation in the setting , composition of the wound care team , outcome measures , and follow up periods between the studies . In both studies , however , the wound care team members received training in wound care management and followed a wound care management protocol . In the RCT , Vu et al. reported a non-significant difference between the proportion of wounds healed in 6 months using a univariate analysis ( 61.7 % for treatment vs. 52.5 % for control ; p=0.074 , RR=1.19 ) There was also a non-significant difference in the mean time to healing in days ( 82 for treatment vs. 101 for control ; p=0.095 ) . More persons in the intervention group had a Brief Pain Inventory ( BPI ) score equal to zero ( better pain control ) at 6 months when compared with the control group ( 38.6 % for intervention vs. 24.4 % for control ; p=0.017 , RR=1.58 ) . By multivariate analysis a statistically significant hazard ratio was reported in the intervention group ( 1.73 , 95 % CI 1.20 - 1.50 ; p=0.003 ) . In the CCT , Harrison et al. reported a statistically significant difference in healing rates between the pre ( control ) and post ( intervention ) phases of the study . Of patients in the pre phase , 23 % had healed ulcers 3 months after study enrolment , whereas 56 % were healed in the post phase ( P<0.001 , OR=4.17 ) ( Figure 3 ) . Furthermore , 27 % of patients were treated daily or more often in the pre phase whereas only 6 % were treated at this frequency in the post phase ( P<0.001 ) , equal to a 34 % relative risk reduction in frequency of daily treatments . The authors did not report the results of pain relief assessment . The body of evidence was assessed using the GRADE methodology for 4 outcomes : proportion of wounds healed , proportion of persons with healed wounds , wound associated pain relief , and proportion of persons needing daily wound treatments . In general , the evidence was found to be low to very low quality . CONCLUSION The evidence supports that managing chronic wounds with a multidisciplinary wound care team significantly increases wound healing and reduces the severity of wound-associated pain and the required daily wound treatments compared to persons not managed by a wound care team . The quality of evidence supporting these outcomes is low to very low meaning that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Background Medication Management Review ( MMR ) is a patient-focused , structured and collaborative health care service provided in the community setting to optimize patient underst and ing and quality use of medicines . Objective To conduct a r and omized control trial of the MMR program in Jordan , by a pharmacist identifying treatment related problems ( TRPs ) through home visits , assessing type and frequency of TRPs , and eventual effect of resolving TRPs identified by the pharmacist and accepted by the physician on the health status of participating patients . Setting Outpatient clinic at the Jordan University Hospital , Amman , Jordan . Method Consecutive patients from outpatient clinics who were eligible for the study were recruited and r and omly distributed into two groups ( control and intervention ) . All patients were visited at home by the pharmacist who delivered only for intervention group counseling regarding self-reported adherence , frequency of monitoring and education regarding pharmacological and non-pharmacological therapy . After identifying TRPs , the pharmacist sent a letter to the physician with certain recommendations for patients in the intervention group only . Physician ticked the approved recommendations and returned the report to the pharmacist , allowing the pharmacist to convey the approved changes to the patients . Patients were referred back to their physicians for confirmation of any changes in treatment . Both groups were reassessed after 2–3 months during their regular follow-up visits to their physicians . Main outcome measure To assess the impact of home medication review on the number of TRPs and self-reported adherence in out patients with chronic diseases via hospital-based clinics in Jordan . Results A total of 158 TRPs were identified in 112 patients ; mean TRP number was 1.63 per patient . As a result of the pharmacist intervention , there was a significant decrease in number of TRPs in the intervention group , the change in the mean was ( 1.23 ( ±1.19 ) , P < 0.001 ) versus the control group ( 0.29 ( ±1.24 ) , P = 0.114 ) . After 3 months , a reduction in non-adherence was observed in the intervention ( −0.81 ( ±1.48 ) , P < 0.001 ) in contrast to no change in self-reported adherence in the control ( 0.22 ( ± 1.12 ) , P = 0.168 ) group . Conclusion Overall , home-based medication review for patients with chronic conditions decreased the total number of TRPs and improved patient self-reported adherence OBJECTIVE Numerous mobile health ( mHealth ) interventions are being developed to aid in management of complex chronic medical conditions . However , the acceptance of mHealth programs by low-income , bilingual population s has not yet been evaluated . The Trial to Examine Text-based mHealth for  Emergency department patients with Diabetes ( TExT-MED ) program is a text message-based mHealth program design ed specifically for re source -poor patients with diabetes . We conducted a prospect i ve proof-of-concept trial to assess satisfaction and preliminary effectiveness of the TExT-MED program . RESEARCH DESIGN AND METHODS A consecutive sample of adult patients in the emergency department with diabetes and a text message-capable mobile phone was enrolled in the TExT-MED program .  Participants received three text messages daily for 3 weeks in English or Spanish in the following domains : educational/motivational , medication reminders , healthy living challenges , diabetes trivia , and links to free diabetes management tools . RESULTS Twenty-three patients with diabetes ( median hemoglobin A1c , 8.9 % ) were enrolled in TExT-MED .  In the week before TExT-MED , 56.5 % of subjects reported eating fruits/vegetables daily versus 83 % after , 43.5 % reported exercising before versus 74 % after , and 74 % reported performing foot checks before versus 85 % after . Self-efficacy , measured by the Diabetes Empowerment Scale-Short Form , improved from 3.9 to 4.2 . Scores on the Morisky Medication Adherence Scale improved more dramatically from 3.5 to 4.75 . Ninety percent of participants indicated they would like to continue the program , and 100 % would recommend the program to family or friends . CONCLUSIONS This pilot trial of the TExT-MED program demonstrated increased healthy behaviors , improved diabetes self-efficacy and medication adherence , and received excellent satisfaction scores in re source -poor , inner city patients with diabetes Background Older adults experiencing multiple chronic illnesses are at high risk of hospitalization and health decline if they are unable to manage the significant challenges posed by their health conditions . Goal -oriented care approaches can provide better care for these complex patients , but clinicians find the process of ascertaining goals “ too complex and too-time consuming , ” and goals are often not agreed upon between complex patients and their providers . The electronic patient reported outcomes ( ePRO ) mobile app and portal offers an innovative approach to creating and monitoring goal -oriented patient-care plans to improve patient self-management and shared decision-making between patients and health care providers . The ePRO tool also supports proactive patient monitoring by the patient , caregiver(s ) , and health care provider . It was developed with and for older adults with complex care needs as a means to improve their quality of life . Objective Our proposed project will evaluate the use , effectiveness , and value for money of the  ePRO tool  in a 12-month multicenter , r and omized controlled trial in Ontario ; targeting individuals 65 or over with two or more chronic conditions that require frequent health care visits to manage their health conditions . Methods Intervention groups using the ePRO tool will be compared with control groups on measures of quality of life , patient experience , and cost-effectiveness . We will also evaluate the implementation of the tool . Results The proposed project presented in this paper will be funded through the Canadian Institute for Health Research ( CIHR ) eHealth Innovation Partnerships Program ( eHIPP ) program ( CIHR–143559 ) . The expected completion date of the study is November , 2019 . Conclusions We anticipate our program of work will support improved quality of life and patient self-management , improved patient-centered primary care delivery , and will encourage the adoption of goal -oriented care approaches across primary health care systems . We have partnered with family health teams and quality improvement organizations in Ontario to ensure that our research is practical and that findings are shared widely . We will work with our established international network to develop an implementation framework to support continued adaptation and adoption across Canada and internationally Background Patients with chronic conditions often use complex medical regimens . A nurse‐led strategy to support medication therapy management incorporated into primary care teams may lead to improved use of medications for disease control . Electronic health record ( EHR ) tools may offer a lower‐cost , less intensive approach to improving medication management . Methods and Results The Northwestern and Access Community Health Network Medication Education Study is a health center – level cluster‐r and omized trial being conducted within a network of federally qualified community health centers . Health centers have been enrolled in groups of 3 and r and omized to ( 1 ) usual care , ( 2 ) EHR‐based medication management tools alone  , or ( 3 ) EHR tools plus nurse‐led medication therapy management . Patients with uncontrolled hypertension who are prescribed ≥3 medications of any kind are recruited from the centers .  EHR tools include a printed medication list to prompt review at each visit and automated plain‐ language medication information within the after‐visit summary to encourage proper medication use . In the nurse‐led intervention , patients receive one‐on‐one counseling about their medication regimens to clarify medication discrepancies and identify drug‐related concerns , safety issues , and nonadherence . Nurses also provide follow‐up telephone calls following new prescriptions and periodically to perform medication review . The primary study outcome is systolic blood pressure after 1 year . Secondary outcomes include measures of underst and ing of dosing instructions , discrepancies between patient‐reported medications and the medical record , adherence , and intervention costs . Conclusions The Northwestern and Access Community Health Network Medication Education Study will assess the effects of 2 approaches to support outpatient medication management among patients with uncontrolled hypertension in federally qualified health center setting s. Clinical Trial Registration URL : clinical trials.gov . Unique identifier : NCT01578577 OBJECTIVE Screening for mental illness in primary care is widely recommended , but little is known about the evaluation , treatment , and long-term management processes that follow screening . The aim of this study was to examine and describe the quality of mental health care for persons with chronic obstructive pulmonary disease ( COPD ) and anxiety/depressive disorders , as measured by adherence to practice guidelines . METHOD This retrospective chart review examined data for 102 primary care and mental health care patients with COPD who were diagnosed , using Structured Clinical Interview for DSM-IV criteria , with major depressive disorder , dysthymia , depression not otherwise specified , generalized anxiety disorder , or anxiety not otherwise specified . Data were gathered from primary care progress notes from the year prior to enrollment in a r and omized controlled trial ( enrollment was from July 2002 to April 2004 ) . We compared the care received by these patients over 1 year with that recommended by practice guidelines . Charts were abstract ed using a checklist of recommended practice guidelines for diagnostic evaluation , acute treatment , and long-term management of anxiety and depressive disorders . RESULTS Fifty ( 49 % ) of the 102 patients were recognized during the review year as having an anxiety or depressive disorder .  Eighteen patients were newly assessed for depressive or anxiety disorders  during the chart review year . Patients followed in primary care alone , compared with those who were comanaged by mental health care providers , were less likely to have guideline -adherent care . CONCLUSION Depressive and anxiety disorders are recognized in about half of patients ; however , guideline -supported diagnostic evaluation , acute treatment ( except for medications ) , and long-term management rarely occur in the primary care setting . To improve the treatment of depressive and anxiety disorders in primary care , the process of care delivery must be understood and changed Background Chronic Obstructive Pulmonary Disease ( COPD ) is a leading cause of disability , hospitalization , and premature mortality . General practice is well placed to diagnose and manage COPD , but there is a significant gap between evidence and current practice , with a low level of awareness and implementation of clinical practice guidelines . Under-diagnosis of COPD is a world-wide problem , limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation , dietary advice , and exercise . General practice is moving towards more structured chronic disease management , and the increasing involvement of practice nurses in delivering chronic care . Design A pragmatic cluster r and omised trial will test the hypothesis that intervention by a practice nurse-general practitioner ( GP ) team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD , compared with usual care . Forty general practice s in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment  . Practice s will be r and omised to deliver either practice nurse-GP partnership care , or usual care , to patients newly-diagnosed with COPD .The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving ( as appropriate ) , smoking cessation , immunisation , pulmonary rehabilitation , medication review , assessment and correction of inhaler technique , nutritional advice , management of psycho-social issues , patient education , and management of co-morbidities . The primary outcome measure is health-related quality of life , assessed with the St George ’s Respiratory Question naire 12 months after diagnosis . Secondary outcome measures include vali date d disease-specific and general health related quality of life measures , smoking and immunisation status , medications , inhaler technique , and lung function . Outcomes will be assessed by project officers blinded to patients ’ r and omization groups . Discussion This study will use proven case-finding methods to identify patients with undiagnosed COPD in general practice , where improved care has the potential for substantial benefit in health and healthcare utilization . The study provides the capacity to trial a new model of team-based assessment and management of newly diagnosed COPD in Australian primary care . Trial registration Background Heart failure ( HF ) is a progressive chronic disease affecting 6.5 million Americans and over 15 million individuals globally . Patients with HF are required to engage in complex self-care behaviors . Although the advancements in medicine have enabled people with HF to live longer , they often have poor health-related quality of life and experience severe and frequent symptoms that limit several aspects of their lives . Mobile phone apps have not only created new and interactive ways of communication between patients and health care providers but also provide a platform to enhance adherence to self-care management . Objective The aim of this pilot study was to test the feasibility of a newly developed mobile app ( HeartMapp ) in improving self-care behaviors and quality of life of patients with HF and to calculate effect sizes for sample size calculation for a larger study . Methods This was a pilot feasibility r and omized controlled trial . Participants were enrolled in the hospital before discharge and followed at home for 30 days . The intervention group used HeartMapp ( n=9 ) , whereas the control group ( n=9 ) received HF education . These apps were downloaded onto their mobile phones for daily use . Results A total of 72 % ( 13/18 ) participants completed the study ; the mean age of the participants was 53 ( SD 4.02 ) years , 56 % ( 10/18 ) were females , 61 % ( 11/18 ) lived alone , 33 % ( 6/18 ) were African Americans , and 61 % ( 11/18 ) used mobile phone to get health information . The mean engagement with HeartMapp was 78 % . Results were promising with a trend that participants in the HeartMapp group had a significant mean score change on self-care management ( 8.7 vs 2.3 ; t3.38=11 , P=.01 ) , self-care confidence ( 6.7 vs 1.8 ; t2.53=11 , P=.28 ) , and HF knowledge ( 3 vs −0.66 ; t2.37=11 , P=.04 . Depression improved among both groups , more so in the control group ( −1.14 vs −5.17 ; t1.97=11 , P=.07 ) . Quality of life declined among both groups , more so in the control group ( 2.14 vs 9.0 ; t−1.43=11 , P=.18 ) . Conclusions The trends demonstrated in this pilot feasibility study warrant further exploration on the use of HeartMapp to improve HF outcomes . Trial Registration Pilot study , no funding from National agencies , hence not registered Background Chronic obstructive pulmonary disease ( COPD ) remains a major health problem , strongly related to smoking . Despite the publication of practice guidelines on prevention and treatment , not all patients with the disease receive the recommended healthcare , particularly with regard to smoking cessation advice where applicable . We have developed a tailored implementation strategy for enhancing general practitioners ’ adherence to the disease management guidelines . The primary aim of the study is to evaluate the effects of this  tailored implementation intervention  on general practitioners ’ adherence to guidelines . Methods / Design A pragmatic two-arm cluster r and omized trial has been planned to compare care following the implementation of tailored interventions of four recommendations in COPD patients against usual care . The study will involve 18 general practice s ( 9 in the intervention group and 9 in the control group ) in Pol and , each with at least 80 identified ( at the baseline ) patients with diagnosed COPD . The nine control practice s will provide usual care without any interventions . Tailored interventions to implement four recommendations will be delivered in the remaining nine practice s. At follow-up after nine months , data will be collected for all 18 general practice s. The primary outcome measure is physicians ’ adherence to all four recommendations : brief anti-smoking advice , dyspnea assessment , care checklist utilization and demonstration to patients of correct inhaler use . This measurement will be based on data extracted from identified patients ’ records . Additionally , we will survey and interview patients with chronic obstructive pulmonary disease about the process of care . Discussion The results of this trial will be directly applicable to primary care in Pol and and add to the growing body of evidence on interventions to improve chronic illness care . Trial registration This trial has been registered with Clinical Trials Protocol Registration System . Trial number : NCT01893476 Background Type 2 diabetes ( T2DM ) affects 113.9 million people in China , the largest number of any country in the world ( JAMA 310:948–59 , 2013 ) . T2DM prevalence has risen dramatically from around 1 % in the 1980s to now over 10 % and is expected to continue rising . Despite the growing disease burden , few people with T2DM are achieving adequate management targets to prevent complications . Health system infrastructure in China is struggling to meet these gaps in care , and innovative , cost-effective and affordable solutions are needed . One promising strategy that may be particularly relevant to the Chinese context is improving support for lay family members to care for their relatives with T2DM . Methods We hypothesise that an interactive mobile health management system can support lay family health promoters ( FHP ) and healthcare staff to improve clinical outcomes for family members with T2DM through medical assessment , regular monitoring , lifestyle advice and the prescribing of guidelines recommended medications . This intervention will be implemented as a cluster r and omised controlled trial involving 80 communities ( 40 communities in Beijing and 40 rural villages in Hebei province ) and 2000 people with T2DM . Outcome analyses will be conducted blinded to intervention allocation . The primary outcome is the proportion of patients achieving ≥2 “ ABC ” goals ( HbA1c < 7.0 % , blood pressure ( BP ) < 140/80 mmHg and LDL cholesterol < 100 mg/dl or 2.6 mmol/L ) at the end of follow-up ( Diabetes Care 36(Supplement 1):S11-S66 , 2013 ) . Secondary outcomes include the proportion of patients achieving individual ABC targets ; mean changes in HbA1c , BP , LDL , renal function ( serum creatinine and urinary albumin ) , body mass index , quality of life ( QOL , EQ-5D ) , and healthcare utilisation from baseline ; and cost-effectiveness/utility of intervention . Trial outcomes will be accompanied by detailed process and economic evaluations . Discussion The Chinese government has prioritised prevention and treatment of diabetes as 1 of 11 National Basic Public Health Services . Despite great promise for mHealth interventions to improve access to effective health care , there remains uncertainty about how this can be successfully achieved . The findings are likely to inform policy on a scalable strategy to overcome sub-optimal access to effective health care in China . Trial registration Clinical trials.gov
There is potential for mHealth tools to better facilitate adherence to chronic disease management , but the evidence supporting its current effectiveness is mixed .
BACKGROUND Adherence to chronic disease management is critical to achieving improved health outcomes , quality of life , and cost-effective health care .
As the burden of chronic diseases continues to grow globally , so does the impact of non-adherence .
Mobile technologies are increasingly being used in health care and public health practice ( mHealth ) for patient communication , monitoring , and education , and to facilitate adherence to chronic diseases management .
OBJECTIVE We conducted a systematic review of the literature to evaluate the effectiveness of mHealth in supporting the adherence of patients to chronic diseases management ( " mAdherence " ) , and the usability , feasibility , and acceptability of mAdherence tools and platforms in chronic disease management among patients and health care providers .