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Additional file 1. E-resource: Topic guide for qualitative interviews with patients and caregivers.

Background: Whilst heart failure (HF) with preserved ejection fraction (HFpEF) affects almost 50 percent of the HF population, evidence-based treatment options remain limited. However, there is growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. Methods: Process evaluation sub-study parallel to a single centre (Tayside, Scotland) randomised controlled pilot trial with qualitative assessment of both intervention fidelity delivery and HFpEF patients’ and caregivers’ experiences. The REACH-HF intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Interviews were conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and 7 caregivers.Results: Qualitative information from the facilitator interactions and interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) patients’ and caregivers’ responses to the REACH-HF intervention. The differing professional backgrounds demonstrate the possibility of delivering REACH-HF by either existing HF or cardiac rehabilitation services of a combination of the two.Conclusions: The REACH-HF home-based facilitated intervention for HFpEF appears feasible and well accepted model for delivery of a cardiac rehabilitation intervention, with the potential to address key unmet needs of patients and their caregivers who are often excluded from service provision and current CR programmes. Results of this study will inform a recently funded full multicentre randomised clinical trial.Trial registration: ISRCTN78539530 (date registration 7th July 2015) http://www.isrctn.com/ISRCTN78539530

Background: Whilst heart failure (HF) with preserved ejection fraction (HFpEF) affects almost 50 percent of the HF population, evidence-based treatment options remain limited. However, there is emerging growing evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention for HFpEF patients and their caregivers conducted as part of the REACH-HFpEF pilot trial. This study reports the process evaluation conducted as part of the REACH-HFpEF trial. Methods: Mixed methods Pprocess evaluation sub study parallel to a single centre (Tayside, Scotland) pilot randomised controlled trial with qualitativequantitative assessment of both intervention fidelity delivery and a qualitative exploration of HFpEF patients’ and caregivers’ experiences. The Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF) intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Data included audio-recorded intervention sessions; demographic information; intervention fidelity scores; and qualitative interviews conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and 7 caregivers.,Results: Intervention fidelity analysis was indicative of the adequate delivery of the majority of the REACH-HF components, with three items relating caregiver involvement (addressing emotional consequences of being a caregiver, caregiver health and well-being, and closure of the session) scoring poorly. Qualitative information from the facilitator interactions and interviews identified three key themes and a number of sub-themes for patients and caregivers: (1) understanding their condition (2) emotional consequences of HF, and (3) patients’ and caregivers’ responses to the REACH-HF intervention were uncovered by qualitative interviews. Different professional backgrounds and typical models of service delivery of facilitators demonstrate to possibility of delivering this through either our HF or CR services of a combination of the two.Conclusions: The REACH-HF home-based facilitated intervention for HFpEF appears feasible and well accepted model for delivery of a CR intervention, with the potential to address key unmet needs of patients and their caregivers who are often excluded from service provision and current CR programmes. Results of this study will inform a future recently funded full multicentre randomised clinical trial.

Background: Whilst heart failure (HF) with preserved ejection fraction (HFpEF) affects almost 50 percent of the HF population, evidence-based treatment options remain limited. However, there is emerging evidence of the potential value of exercise-based cardiac rehabilitation. This study reports the process evaluation conducted as part of the REACH-HFpEF trial. Methods: Mixed methods process evaluation parallel to a single centre (Tayside, Scotland) pilot randomised controlled trial with quantitative assessment of intervention fidelity and a qualitative exploration of HFpEF patients’ and caregivers’ experiences. The Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF) intervention consisted of self-help manual for patients and caregivers, facilitated over 12 weeks by trained healthcare professionals. Data included audio-recorded intervention sessions; demographic information; intervention fidelity scores; and qualitative interviews conducted following completion of intervention in a purposeful sample of 15 HFpEF patients and 7 caregivers, Results: Intervention fidelity analysis was indicative of the adequate delivery of the majority of the REACH-HF components, with three items relating caregiver involvement (addressing emotional consequences of being a caregiver, caregiver health and well-being, and closure of the session) scoring poorly. Qualitative interviews identified three key themes for patients and caregivers: (1) understanding their condition, (2) emotional consequences of HF, and (3) patients’ and caregivers’ responses to the REACH-HF intervention were uncovered by qualitative interviews. Conclusions: The REACH-HF home-based facilitated intervention for HFpEF appears feasible and well accepted model for delivery of a CR intervention, with the potential to address key unmet needs of patients and their caregivers who are often excluded from service provision and current CR programmes. Results inform a future full multicentre randomised clinical trial.

This study performed a contemporary systematic review and meta-analysis of exercise-based cardiac rehabilitation (ExCR) for heart failure (HF).There is an increasing call for trials of models of ExCR for patients with HF that provide alternatives to conventional center-based provision and recruitment of patients that reflect a broader HF population.The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, and PsycINFO databases were searched between January 2013 and January 2018. Randomized trials comparing patients undergoing ExCR to control patients not undergoing exercise were included. Study outcomes were pooled using meta-analysis. Metaregression examined potential effect modification according to ExCR program characteristics, and risk of bias, trial sequential analysis (TSA), and Grading of Recommendations Assessment Development and Evaluation (GRADE) were applied.Across 44 trials (n = 5,783; median follow-up of 6 months), compared with control subjects, ExCR did not reduce the risk of all-cause mortality (relative risk [RR]: 0.89; 95% confidence interval [CI]: 0.66 to 1.21; TSA-adjusted CI: 0.26 to 3.10) but did reduce all-cause hospitalization (RR: 0.70; 95% CI: 0.60 to 0.83; TSA-adjusted CI: 0.54 to 0.92) and HF-specific hospitalization (RR: 0.59; 95% CI: 0.42 to 0.84; TSA-adjusted CI: 0.14 for 2.46), and patients reported improved Minnesota Living with Heart Failure questionnaire overall scores (mean difference: -7.1; 95% CI: -10.5 to -3.7; TSA-adjusted CI: -13.2 to -1.0). No evidence of differential effects across different models of delivery, including center- versus home-based programs, were found.This review supports the beneficial effects of ExCR on patient outcomes. These benefits appear to be consistent across ExCR program characteristics. GRADE and TSA assessments indicated that further high-quality randomized trials are needed.

The REACH-HF Facilitation Process. (PDF 280 kb)

Extracts from intervention maps for stress management, medication management and managing symptoms. (PDF 267 kb)

Needs assessment questionnaire. (PDF 552 kb)

Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) Feasibility Study Report. (PDF 563 kb)

REACH-HF Needs Assessment Summary. (PDF 492 kb)

BACKGROUND: Chronic heart failure (HF) is a growing global health challenge. People with HF experience substantial burden that includes low exercise tolerance, poor health‐related quality of life (HRQoL), increased risk of mortality and hospital admission, and high healthcare costs. The previous (2014) Cochrane systematic review reported that exercise‐based cardiac rehabilitation (CR) compared to no exercise control shows improvement in HRQoL and hospital admission among people with HF, as well as possible reduction in mortality over the longer term, and that these reductions appear to be consistent across patient and programme characteristics. Limitations noted by the authors of this previous Cochrane Review include the following: (1) most trials were undertaken in patients with HF with reduced (< 45%) ejection fraction (HFrEF), and women, older people, and those with preserved (≥ 45%) ejection fraction HF (HFpEF) were under‐represented; and (2) most trials were undertaken in the hospital/centre‐based setting. OBJECTIVES: To determine the effects of exercise‐based cardiac rehabilitation on mortality, hospital admission, and health‐related quality of life of people with heart failure. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and three other databases on 29 January 2018. We also checked the bibliographies of systematic reviews and two trial registers. SELECTION CRITERIA: We included randomised controlled trials that compared exercise‐based CR interventions with six months' or longer follow‐up versus a no exercise control that could include usual medical care. The study population comprised adults (> 18 years) with evidence of HF ‐ either HFrEF or HFpEF. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all identified references and rejected those that were clearly ineligible for inclusion in the review. We obtained full papers of potentially relevant trials. Two review authors independently extracted data from the included trials, assessed their risk of bias, and performed GRADE analyses. MAIN RESULTS: We included 44 trials (5783 participants with HF) with a median of six months' follow‐up. For this latest update, we identified 11 new trials (N = 1040), in addition to the previously identified 33 trials. Although the evidence base includes predominantly patients with HFrEF with New York Heart Association classes II and III receiving centre‐based exercise‐based CR programmes, a growing body of studies include patients with HFpEF and are undertaken in a home‐based setting. All included studies included a no formal exercise training intervention comparator. However, a wide range of comparators were seen across studies that included active intervention (i.e. education, psychological intervention) or usual medical care alone. The overall risk of bias of included trials was low or unclear, and we downgraded results using the GRADE tool for all but one outcome. Cardiac rehabilitation may make little or no difference in all‐cause mortality over the short term (≤ one year of follow‐up) (27 trials, 28 comparisons (2596 participants): intervention 67/1302 (5.1%) vs control 75/1294 (5.8%); risk ratio (RR) 0.89, 95% confidence interval (CI) 0.66 to 1.21; low‐quality GRADE evidence) but may improve all‐cause mortality in the long term (> 12 months follow up) (6 trials/comparisons (2845 participants): intervention 244/1418 (17.2%) vs control 280/1427 (19.6%) events): RR 0.88, 95% CI 0.75 to 1.02; high‐quality evidence). Researchers provided no data on deaths due to HF. CR probably reduces overall hospital admissions in the short term (up to one year of follow‐up) (21 trials, 21 comparisons (2182 participants): (intervention 180/1093 (16.5%) vs control 258/1089 (23.7%); RR 0.70, 95% CI 0.60 to 0.83; moderate‐quality evidence, number needed to treat: 14) and may reduce HF‐specific hospitalisation (14 trials, 15 comparisons (1114 participants): (intervention 40/562 (7.1%) vs control 61/552 (11.1%) RR 0.59, 95% CI 0.42 to 0.84; low‐quality evidence, number needed to treat: 25). After CR, a clinically important improvement in short‐term disease‐specific health‐related quality of life may be evident (Minnesota Living With Heart Failure questionnaire ‐ 17 trials, 18 comparisons (1995 participants): mean difference (MD) ‐7.11 points, 95% CI ‐10.49 to ‐3.73; low‐quality evidence). Pooling across all studies, regardless of the HRQoL measure used, shows there may be clinically important improvement with exercise (26 trials, 29 comparisons (3833 participants); standardised mean difference (SMD) ‐0.60, 95% CI ‐0.82 to ‐0.39; I² = 87%; Chi² = 215.03; low‐quality evidence). ExCR effects appeared to be consistent different models of ExCR delivery: centre vs. home‐based, exercise dose, exercise only vs. comprehensive programmes, and aerobic training alone vs aerobic plus resistance programmes. AUTHORS' CONCLUSIONS: This updated Cochrane Review provides additional randomised evidence (11 trials) to support the conclusions of the previous version (2014) of this Cochane Review. Compared to no exercise control, CR appears to have no impact on mortality in the short term (< 12 months' follow‐up). Low‐ to moderate‐quality evidence shows that CR probably reduces the risk of all‐cause hospital admissions and may reduce HF‐specific hospital admissions in the short term (up to 12 months). CR may confer a clinically important improvement in health‐related quality of life, although we remain uncertain about this because the evidence is of low quality. Future ExCR trials need to continue to consider the recruitment of traditionally less represented HF patient groups including older, female, and HFpEF patients, and alternative CR delivery settings including home‐ and using technology‐based programmes.