The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials Telemonitoring of heart failure patients and their caregivers: a pilot randomized controlled trial. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. A trial of family partnership and education interventions in heart failure. A Randomized Trial of Mobile Health Support for Heart Failure Patients and Their Informal Caregivers: Impacts on Caregiver-reported Outcomes Clinical effectiveness and cost-effectiveness of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) facilitated self-care rehabilitation intervention in heart failure patients and caregivers: rationale and protocol for a multicentre randomised controlled trial Measuring Comorbidity in Cardiovascular Research: A Systematic Review Caregiving tasks and caregiver burden; effects of an psycho-educational intervention in partners of patients with post-operative heart failure. Mutuality and heart failure self-care in patients and their informal caregivers Family partnership and education interventions to reduce dietary sodium by patients with heart failure differ by family functioning. Psychoeducational support to post cardiac surgery heart failure patients and their partners--a randomised pilot study. Telecare for Diabetes, CHF or COPD: Effect on Quality of Life, Hospital Use and Costs. A Randomised Controlled Trial and Qualitative Evaluation A professional-patient partnership model of discharge planning with elders hospitalized with heart failure. Long Term Follow-Up after a Randomized Integrated Educational and Psychosocial Intervention in Patient-Partner Dyads Affected by Heart Failure Caregiver coaching program effect: Reducing heart failure patient rehospitalizations and improving caregiver outcomes among African Americans. Dyads affected by chronic heart failure: a randomized study evaluating effects of education and psychosocial support to patients with heart failure and their partners. The effect of family training and support on the quality of life and cost of hospital readmissions in congestive heart failure patients in Iran. Family education and support interventions in heart failure: a pilot study. Long-term effects of a dyadic psycho-educational intervention on caregiver burden and morbidity in partners of patients with heart failure: a randomized controlled trial Cost-effectiveness of a nurse-led education and psychosocial programme for patients with chronic heart failure and their partners. Exploring the Relationship of Patient and Informal Caregiver Characteristics with Heart Failure Self-Care Using the Actor-Partner Interdependence Model: Implications for Outpatient Palliative Care. Family partner intervention influences self-care confidence and treatment self-regulation in patients with heart failure
To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Heart failure ( HF ) is the leading cause of rehospitalization in older adults . The purpose of this pilot study was to examine whether telemonitoring by an advanced practice nurse reduced subsequent hospital readmissions , emergency department visits , costs , and risk of hospital readmission for patients with HF . One hundred two patient/caregiver dyads were r and omized into 2 groups postdischarge ; 84 dyads completed the study . Hospital readmissions , emergency department visits , costs , and days to readmission were abstract ed from medical records . Participants were interviewed soon after discharge and 3 months later about effects of telemonitoring on depressive symptoms , quality of life , and caregiver mastery . There were no significant differences due to telemonitoring for any outcomes . Caregiver mastery , informal social support , and electronic home monitoring were not significant predictors for risk of hospital readmission . Further studies should address the interaction between the advanced practice nurse and follow-up intervention with telemonitoring of patients with HF to better target those who are most likely to benefit IMPORTANCE It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure ( HF ) after hospitalization . OBJECTIVE To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF . DESIGN , SETTING , AND PARTICIPANTS We r and omized 1437 patients hospitalized for HF between October 12 , 2011 , and September 30 , 2013 , to the intervention arm ( 715 patients ) or to the usual care arm ( 722 patients ) of the Better Effectiveness After Transition-Heart Failure ( BEAT-HF ) study and observed them for 180 days . The date s of our study analysis were March 30 , 2014 , to October 1 , 2015 . The setting was 6 academic medical centers in California . Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF . INTERVENTIONS The intervention combined health coaching telephone calls and telemonitoring . Telemonitoring used electronic equipment that collected daily information about blood pressure , heart rate , symptoms , and weight . Central ized registered nurses conducted telemonitoring review s , protocol ized actions , and telephone calls . MAIN OUTCOMES AND MEASURES The primary outcome was readmission for any cause within 180 days after discharge . Secondary outcomes were all-cause readmission within 30 days , all-cause mortality at 30 and 180 days , and quality of life at 30 and 180 days . RESULTS Among 1437 participants , the median age was 73 years . Overall , 46.2 % ( 664 of 1437 ) were female , and 22.0 % ( 316 of 1437 ) were African American . The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge , which occurred in 50.8 % ( 363 of 715 ) and 49.2 % ( 355 of 722 ) of patients , respectively ( adjusted hazard ratio , 1.03 ; 95 % CI , 0.88 - 1.20 ; P = .74 ) . In secondary analyses , there were no significant differences in 30-day readmission or 180-day mortality , but there was a significant difference in 180-day quality of life between the intervention and usual care groups . No adverse events were reported . CONCLUSIONS AND RELEVANCE Among patients hospitalized for HF , combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01360203 BACKGROUND Lowering dietary sodium and adhering to medication regimens are difficult for persons with heart failure ( HF ) . Because these behaviors often occur within the family context , this study evaluated the effects of family education and partnership interventions on  dietary sodium ( Na ) intake and medication adherence ( MA ) . METHODS AND RESULTS HF patient and family member ( FM ) dyads ( n = 117 ) were r and omized to : usual care ( UC ) , patient-FM education ( PFE ) , or family partnership intervention ( FPI ) . Dietary Na ( 3-day food record ) , urinary Na ( 24-hour urine ) , and MA ( Medication Events Monitoring System ) were measured at baseline ( BL ) before r and omization , and at 4 and 8 months . FPI and PFE reduced urinary Na at 4 months , and FPI differed from UC at 8 months ( P = .016 ) . Dietary Na decreased from BL to 4 months , with both PFE ( P = .04 ) and FPI ( P = .018 ) lower than UC . The proportion of subjects adherent to Na intake ( ≤2,500 mg/d ) was higher at 8 months in PFE and FPI than in UC ( χ(2)(2 ) = 7.076 ; P = .029 ) . MA did not differ among groups across time . Both FPI and PFE groups increased HF knowledge immediately after intervention . CONCLUSIONS Dietary Na intake , but not MA , was improved by PFE and FPI compared with UC . The UC group was less likely to be adherent with dietary Na . Greater efforts to study and incorporate family-focused education and support interventions into HF care are warranted 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 Introduction The Rehabilitation EnAblement in CHronic Heart Failure ( REACH-HF ) trial is part of a research programme design ed to develop and evaluate a health professional facilitated , home-based , self-help rehabilitation intervention to improve self-care and health-related quality of life in people with heart failure and their caregivers . The trial will assess the clinical effectiveness and cost-effectiveness of the REACH-HF intervention in patients with systolic heart failure and impact on the outcomes of their caregivers . Methods and analysis A parallel two group r and omised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care ( intervention group ) or usual care alone ( control group ) in 216 patients with systolic heart failure ( ejection fraction < 45 % ) and their caregivers . The intervention comprises a self-help manual delivered by specially trained facilitators over a 12-week period . The primary outcome measure is patients ’ disease-specific health-related quality of life measured using the Minnesota Living with Heart Failure question naire at 12 months ’ follow-up . Secondary outcomes include survival and heart failure related hospitalisation , blood biomarkers , psychological well-being , exercise capacity , physical activity , other measures of quality of life , patient safety and the quality of life , psychological well-being and perceived burden of caregivers at 4 , 6 and 12 months ’ follow-up . A process evaluation will assess fidelity of intervention delivery and explore potential mediators and moderators of changes in health-related quality of life in intervention and control group patients . Qualitative studies will describe patient and caregiver experiences of the intervention . An economic evaluation will estimate the cost-effectiveness of the REACH-HF intervention plus usual care versus usual care alone in patients with systolic heart failure . Ethics and dissemination The study is approved by the North West — Lancaster Research Ethics Committee ( ref 14/NW/1351 ) . Findings will be disseminated via journals and presentations to publicise the research to clinicians , commissioners and service users . Trial registration number IS RCT N86234930 ; Pre- results Background . Everything known about the roles , relationships , and repercussions of comorbidity in cardiovascular disease is shaped by how comorbidity is currently measured . Objectives . To critically examine how comorbidity is measured in r and omized controlled trials or clinical trials and prospect i ve observational studies in acute myocardial infa rct ion ( AMI ) , heart failure ( HF ) , or stroke . Design . Systematic review of studies of hospitalized adults from MEDLINE CINAHL , PsychINFO , and ISI Web of Science Social Science data bases . At least two review ers screened and extracted all data . Results . From 1432 review ed abstract s , 26 studies were included ( AMI n = 8 , HF n = 11 , stroke n = 7 ) . Five studies used an  instrument  to  measure comorbidity  while the remaining used the presence or absence of an unsubstantiated list of individual diseases . Comorbidity data were obtained from 1–4 different sources with 35 % of studies not reporting the source . A year-by-year analysis showed no changes in measurement . Conclusions . The measurement of comorbidity remains limited to a list of conditions without stated rationale or st and ards increasing the likelihood that the true impact is underestimated OBJECTIVE To evaluate the effects of a psycho-educational intervention on caregiver burden in partners of patients with postoperative heart failure . BACKGROUND Since partners of cardiac surgery patients play a significant role in the patient 's recovery , it is important to address their needs during hospitalization and after discharge . METHODS Forty-two patients with postoperative heart failure and their partners participated in a r and omized controlled pilot study . Dyads in the intervention group received psycho-educational support from a multidisciplinary team . Dyads in the control group received usual care . RESULTS No significant differences were found in the performance of caregiving tasks and perceived caregiver burden in the control versus the intervention group . CONCLUSION A pilot study exploring the effects of a psycho-educational intervention in patients and their partners did not reveal significant effects with regard to reduced feelings of burden in partners . Alleviating caregiver burden in partners may need a more intense or specific approach Background : Heart failure is a progressive condition characterized by frequent hospitalizations for exacerbated symptoms . Informal family caregivers may help patients improve self-care , which may in turn reduce hospitalizations . However , little is known about how mutuality , defined as the quality of the patient – caregiver relationship , and caregiver burden affect self-care . Objective : This study examines the associations among mutuality , patient self-care confidence ( beliefs in abilities to engage in self-care behaviors ) and maintenance ( behaviors such as medication adherence , activity , and low salt intake ) , caregiver confidence in and maintenance of patient care , and caregiver perceived burden . Methods : This study used cross-sectional baseline data from a multi-site r and omized clinical trial of a symptom and psychosocial care intervention . Patient – caregiver dyads ( N=99 ) completed self-report surveys of mutuality and self-care confidence and maintenance , and caregivers completed a measure of caregiver burden . Path analysis , with actor ( effects within a person ) partner ( effects across the dyad ) interdependence model paths and regression models were used to examine the associations among mutuality , caregiver burden , and self-care . Results : The majority of patients ( M age=66 , 21 % female ) and caregivers ( M age=57 , 81 % female ) were spouses ( 60 % ) . The path model demonstrated significant actor effects ; patients and caregivers with better mutuality were more confident in patient self-care ( p<.05 ) . Partner effects were not significant . Regression models indicated that caregivers with greater mutuality reported less perceived burden ( p<.01 ) . Conclusions : Mutuality in patient – caregiver dyads is associated with patient self-care and caregiver burden and may be an important intervention target to improve self-care and reduce hospitalizations OBJECTIVES Determine if family functioning influences response to family-focused interventions aim ed at reducing dietary sodium by heart failure ( HF ) patients . BACKGROUND Lowering dietary sodium by HF patients often occurs within the home and family context . METHODS Secondary analysis of 117 dyads r and omized to patient and family education ( PFE ) , family partnership intervention ( FPI ) or usual care ( UC ) .  Dietary sodium measures were obtained from 3-day food record and 24-h urine sample s. RESULTS In the poor family functioning groups , FPI and PFE had lower mean urine sodium than UC ( p < .05 ) at 4 months , and FPI remained lower than UC at 8 months ( p < .05 ) . For good family functioning groups , FPI and PFE had lower mean sodium levels by 3-day food record at 4 and 8 months compared to the UC group . CONCLUSION Optimizing family-focused interventions into HF clinical care maybe indicated OBJECTIVES Postoperative heart failure is a serious complication that changes the lives of both the person who is critically ill and family in many ways . The purpose of this study was to evaluate the effects of an intervention in postoperative heart failure patient-partner dyads regarding health , symptoms of depression and perceived control . RESEARCH METHODOLOGY / DESIGN Pilot study with a r and omised controlled design evaluating psychosocial support and education from an interdisciplinary team . SETTING Patients with postoperative heart failure and their partners . MAIN OUTCOME MEASURES SF-36 , Beck Depression Inventory , Perceived Control at baseline , 3 and 12 months . RESULTS A total of 42 patient-partner completed baseline assessment . Partners in the intervention group increased health in the role emotional and mental health dimensions and patients increased health in vitality , social function and mental health dimensions compared with the control group . Patients ' perceived control improved significantly in the intervention group over time . CONCLUSION Psychoeducational support to post cardiac surgery heart failure dyads improved health in both patients and partners at short term follow-up and improved patients ' perceived control at both short and long-term follow-up . Psychoeducational support appears to be a promising intervention but the results need to be confirmed in larger studies Objectives To assess the effect of telecare on health related quality of life , self-care , hospital use , costs and the experiences of patients , informal carers and health care professionals . Methods Patients were r and omly assigned either to usual care or to additionally entering their data into a commercially-available electronic device that uploaded data once a day to a nurse-led monitoring station . Patients had congestive heart failure ( Site A ) , chronic obstructive pulmonary disease ( Site B ) , or any long-term condition , mostly diabetes ( Site C ) . Site C contributed only intervention patients – they considered a usual care option to be unethical . The study took place in New Zeal and between September 2010 and February 2012 , and lasted 3 to 6 months for each patient . The primary outcome was health-related quality of life ( SF36 ) . Data on experiences were collected by individual and group interviews and by question naire . Results There were 171 patients ( 98 intervention , 73 control ) . Quality of life , self-efficacy and disease-specific measures did not change significantly , while anxiety and depression both decreased significantly with the intervention . Hospital admissions , days in hospital , emergency department visits , outpatient visits and costs did not differ significantly between the groups . Patients at all sites were universally positive . Many felt safer and more cared-for , and said that they and their family had learned more about managing their condition . Staff could all see potential benefits of telecare , and , after some initial technical problems , many staff felt that telecare enabled them to effectively monitor more patients . Conclusions Strongly positive patient and staff experiences and attitudes complement and contrast with small or non-significant quantitative changes . Telecare led to patients and families taking a more active role in self-management . It is likely that subgroups of patients benefitted in ways that were not measured or visible within the quantitative data , especially feelings of safety and being cared-for . Trial Registration Australian New Zeal and Clinical Trials Registry Despite efforts to improve the discharge planning process and subsequent outcomes , existing mechanisms fail to accurately identify elders ' needs for follow-up care . Studies report rehospitalization rates ranging from 12 to 50 % . The two aims of this study were to ( 1 ) examine the difference in outcomes for elders hospitalized with heart failure and caregivers who participated in a professional-patient partnership model of discharge planning  compared to those who received the usual discharge planning  and ( 2 ) examine differences in costs associated with hospital readmission and use of the emergency room following hospital discharge . A before- and -after nonequivalent control group design was used for this study . Data were collected from the control and the intervention cohorts before discharge and at 2 weeks and 2 months postdischarge . One hundred and fifty-eight patient-caregiver dyads completed both the predischarge and 2-weeks postdischarge interviews ; 140 also completed a 2-month follow up . The average age of elders was 73.7 years ; the average age of the caregivers was 58.5 years . The findings indicated that elders in the intervention cohort felt more prepared to manage care , reported more continuity of information about care management and services , felt they were in better health , and when readmitted spent fewer days in the hospital than the control cohort . Caregivers in the intervention cohort also reported receiving more information about care management and having a more positive reaction to caregiving 2 weeks postdischarge than the control cohort Background To date , contemporary heart failure care remains patient-focused , but awareness of the partners ’ and families ’ situation is increasing . R and omized studies have mainly evaluated the short-term effects of dyadic interventions . Therefore , the aim of this study was to determine the 24-month effects of an intervention with psych-educational support in dyads of heart failure patients and their partners . Methods This study used a r and omized study design and 155 patient-partner dyads were enrolled . The intervention included a nurse-led program of three sessions addressing psychoeducational support . Results The intervention did not have any effect on health , depressive symptoms or perceived control among the patient-partner dyads after 24 months . Furthermore , time to first event did not differ significantly between the intervention group and the control patients . Conclusion This study may be regarded as a first step in trying to underst and dyads ’ need for supportive care . Individualized and more targeted interventions seem necessary to achieve a higher impact on dyad outcomes . Trial Registration Clinical Trials.gov OBJECTIVES ( 1 ) Test whether FamHFcare intervention could reduce patients ' heart failure (HF)-related rehospitalizations and improve family caregiver outcomes ; ( 2 ) calculate effect size on caregiver outcomes ; and ( 3 ) evaluate the FamHFcare . BACKGROUND Few interventions target family caregivers for HF home care . METHODS This study was a mixed method design with stratification and r and om assignment of 20 African American HF patient/caregiver dyads . Descriptive , univariate parametric/non-parametric , and post-hoc analyses were used . RESULTS At 6 months , compared to st and ard care , the intervention group had significantly fewer HF rehospitalizations ( M-W z = -1.8 , p = 0.03 ) , while caregiver confidence ( M-W z = 2.8 , p = 0.003 ) and social support scores ( M-W z = 2.4 , p = 0.01 ) were significantly higher , and caregiver depression ( M-W z = -2.4 , p = 0.01 ) were significantly lower . Caregivers rated the FamHFcare  as helpful ( M = 46.8 ± 4.1 ) . CONCLUSIONS The FamHFcare intervention was associated with fewer HF patient rehospitalizations and improved caregiver outcomes BACKGROUND Chronic heart failure ( CHF ) causes great suffering for both patients and their partners . The aim of this study was to evaluate the effects of an integrated dyad care program with education and psychosocial support to patients with CHF and their partners during a postdischarge period after acute deterioration of CHF . METHODS One hundred fifty-five patient-caregiver dyads were r and omized to usual care ( n = 71 ) or a psychoeducation intervention ( n = 84 ) delivered in 3 modules through nurse-led face-to-face counseling , computer-based education , and other written teaching material s to assist dyads to develop problem-solving skills . Follow-up assessment s were completed after 3 and 12 months to assess perceived control , perceived health , depressive symptoms , self-care , and caregiver burden . RESULTS Baseline sociodemographic and clinical characteristics of dyads in the experimental and control groups were similar at baseline . Significant differences were observed in patients ' perceived control over the cardiac condition after 3 ( P < .05 ) but not after 12 months , and no effect was seen for the caregivers . No group differences were observed over time in dyads ' health-related quality of life and depressive symptoms , patients ' self-care behaviors , and partners ' experiences of caregiver burden . CONCLUSIONS Integrated dyad care focusing on skill-building and problem-solving education and psychosocial support was effective in initially enhancing patients ' levels of perceived control . More frequent professional contact and ongoing skills training may be necessary to have a higher impact on dyad outcomes and warrants further research BACKGROUND This study was conducted to investigate the effects of family training and support on quality of life and cost of hospital readmissions in congestive heart failure patients . METHODS In this single-blinded , r and omized , controlled trial , the participants were heart failure patients hospitalized in an Iranian hospital . Data were collected from available hospitalized patients . The participants were enrolled through r and omized sampling and were divided r and omly into two groups , an intervention group and a control group . The intervention group received extra training package for the disease . Training was provided at discharge and three months after . A st and ard question naire to assess the QoL was filled out by both groups at discharge and six months after . RESULTS Mean scores of QoL domains at the beginning of the study decreased in control group and increased in intervention in comparison with six months after ( p<0.01 ) . CONCLUSION Nursing care follow-up according to heart failure patients ' needs promoted their BACKGROUND Self-management of dietary sodium restriction by persons with heart failure ( HF ) is difficult and usually occurs within the home setting and within a family context . OBJECTIVE To compare a patient and family education ( EDUC ) intervention with a combined education and family partnership intervention ( EDUC + FPI ) for effects on improving dietary sodium self-management in persons with HF . METHODS Patients with HF and a family member ( FM ) were r and omized to EDUC ( n = 29 dyads ) or EDUC + FPI ( n = 32 dyads ) . Participants with HF were primarily White males with a mean age of 61 years ( + /-12 ) . The FMs were primarily women and spouses and had a mean age of 54 years ( + /-17 ) .  Self-reported dietary sodium ( Diet NA ) intake and 24-hr urinary sodium ( Urine NA ) were measured at baseline ( BL ) and 3 months ( 3 M ) after intervention . Data were analyzed with descriptive statistics , generalized least squares regression , paired t test , and chi-square test . RESULTS Groups did not differ by age , gender , or clinical variables ; however , family functioning ( Family APGAR ) scores were slightly higher in the EDUC + FPI group at BL . Both groups decreased Diet NA and Urine NA from BL to 3 M ; the EDUC + FPI group showed greater decrease in Urine NA and had a greater percentage of those who decreased Urine NA by at least 15 % ( p = .04 ) . Regression analysis to predict Urine NA revealed a significant Group x Time interaction ( p = .03 ) when accounting for time-varying measures of body mass index ( p = .001 ) . DISCUSSION A family-focused intervention may be useful in reducing dietary sodium intake in persons with HF . The Urine NA results support the importance of incorporating family-focused education and support interventions into HF care Background Partners of patients with heart failure provide both practical and emotional support . Many partners assume caregiving responsibilities without being aware of the burden related with this role . Objective Our work has established that a psycho-educational intervention has benefits at 3 , but not at 12 months for patients with heart failure . Further we had not described the long-term effects in caregivers . This study aim ed to determine the 24-months effects of a dyadic psycho-educational intervention on caregiver burden and morbidity in partners of patients with heart failure and study factors associated with a change in caregiver burden . Design A r and omized controlled study design , with a follow-up assessment after 24 months . Setting and participants Partners to patients with heart failure were recruited from two hospitals in the southeast of Sweden . InterventionA three session nurse-led psycho-educational program was tested and included psychosocial support to maintain the partners ’ physical and mental functions , and perceived control . Several instrument were used to measure caregiver burden , perceived control , physical and mental health , depression and morbidity . Results One hundred fifty-five partners were included . There were no significant differences in any index of caregiver burden or morbidity among the partners in the intervention and control groups after 24 months . Overall , the mean total caregiver burden was found to be significantly increased compared to baseline ( 36 ± 12 vs 38 ± 14 , p < 0.05 ) . A younger partner , less comorbidity , higher levels of perceived control , better physical health and less symptoms of depression in patients , and better mental health in the partners were factors associated with absence of increased caregiver burden over time . Discussion and conclusion Our intervention did not significantly decrease caregiver burden or morbidity . Over time , several aspects of burden increased in both groups . To improve outcomes , individualized and targeted interventions might be beneficial . Registered on Clinical Trials.gov IdentifierNCT02398799 AIMS AND OBJECTIVES This r and omised controlled trial was conducted to estimate the cost-effectiveness of a nurse-led education and psychosocial support programme for patients with heart failure ( HF ) and their partners . BACKGROUND There are few studies evaluating cost-effectiveness of interventions among HF patient-partner dyads . METHODS Dyads r and omised to the experimental group received nurse-led counselling , computer-based education and written material s aim ed at developing problem-solving skills at two , six and 12 weeks after hospitalisation with HF exacerbation . The dyads in the control group received usual care . A cost-effectiveness analysis that included costs associated with staff time to deliver the intervention and travel costs was conducted at 12 months . Quality -adjusted life-year ( QALY ) weights for patients and partners were estimated by SF-6D . RESULTS A total of 155 dyads were included . The intervention cost was € 223 per patient . Participants in both groups showed improvements in QALY weights after 12 months . However , no significant difference in QALY weights was found between the patients in the two groups , nor among their partners . CONCLUSION The intervention was not proven cost-effective , neither for patients nor for partners . The intervention , however , had trends ( but not significant ) effects on the patient-partner dyads , and by analysing the QALY gained from the dyad , a reasonable mean cost-effectiveness ratio was achieved . RELEVANCE TO CLINICAL PRACTICE The study shows trends of a cost-effective education and psychosocial care of HF patient-partner dyads BACKGROUND The convergence of prevalence , cost , symptom experience , community setting , and informal caregiving in heart failure ( HF ) has profound implication s for outpatient palliative care . The majority of HF patients depend on  informal caregiver 's assistance . Dyadic ( patients and caregiver ) characteristics can complicate this assistance . Yet relatively little is known concerning dyadic characteristics ' impact on self-care . HF self-care involves routine , daily treatment adherence and symptom monitoring ( self-care maintenance ) , and symptom response ( self-care management ) . OBJECTIVE Describe the dyadic characteristics of mood and perception of the relationship in HF patients and caregivers , then explore the relationship of the characteristics with self-care . DESIGN Prospect i ve , cross sectional study of hospitalized HF patients in mixed dyads ( spousal/adult child/relative ) analyzed using Actor-Partner Interdependence Model ( APIM ) techniques . MEASUREMENTS Mood was measured by the Brief Symptom Inventory and  Patient Health Question naire , perception of the relationship by the Dyadic Adjustment Scale , and self-care by the Self-care in Heart Failure Index . RESULTS In 40 dyads the average patient was a 71 year old male ( n = 30 ) ; caregiver was a 59 years old female ( n = 26 ) .  Overall self-care scores were consistently low . Patient depression scores were significantly greater than caregivers ( p = .0055 ) . Greater caregiver anxiety were associated with lower caregiver maintenance scores ( p < .0001 ) but greater caregiver depression were associated with lower patient maintenance scores ( p < .0001 ) . While patient and caregiver 's perception of the relationship was associated with their self-care , more importantly , caregiver 's perception of the relationship was associated with their confidence to engage in the patient 's self-care ( p = .003 ) . DISCUSSION / CONCLUSION This study suggests that caregivers , often unacknowledged or unmeasured , impact patient 's day to day HF self-care . Palliative care clinicians need to talk to dyads with a history of poor self-care about their relationship Background : Heart failure self-care requires confidence in one ’s ability and motivation to perform a recommended behavior . Most self-care occurs within a family context , yet little is known about the influence of family on heart failure self-care or motivating factors . Aims : To examine the association of family functioning and the self-care antecedents of confidence and motivation among heart failure participants and determine if a family partnership intervention would promote higher levels of perceived confidence and treatment self-regulation ( motivation ) at four and eight months compared to patient – family education or usual care groups . Methods : Heart failure patients ( N=117 ) and a family member were r and omized to a family partnership intervention , patient – family education or usual care groups .  Measures of patient ’s perceived family functioning , confidence , motivation for medications and following a low-sodium diet  were analyzed . Data were collected at baseline , four and eight months . Results : Family functioning was related to self-care confidence for diet ( p=0.02 ) and autonomous motivation for adhering to their medications ( p=0.05 ) and diet ( p=0.2 ) . The family partnership intervention group significantly improved confidence ( p=0.05 ) and motivation ( medications ( p=0.004 ; diet p=0.012 ) at four months , whereas patient – family education group and usual care did not change . Conclusion : Perceived confidence and motivation for self-care was enhanced by family partnership intervention , regardless of family functioning . Poor family functioning at baseline contributed to lower confidence . Family functioning should be assessed to guide tailored family – patient interventions for better outcomes
BACKGROUND Having support from an informal carer is important for heart failure patients .
Carers have the potential to improve patient self-care .
At the same time , it should be acknowledged that caregiving could affect the carer negatively and cause emotional reactions of burden and stress .
Dyadic ( patient and informal carer ) heart failure self-care interventions seek to improve patient self-care such as adherence to medical treatment , exercise training , symptom monitoring and symptom management when needed .
Currently , no systematic assessment of dyadic interventions has been conducted with a focus on describing components , examining physical and delivery context s , or determining the effect on patient and /or carer outcomes .
OBJECTIVE To examine the components , context , and outcomes of dyadic self-care interventions .