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

Abstract

IntroductionThe Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) trial is part of a research programme designed 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 analysisA parallel two group randomised 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 questionnaire 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 disseminationThe 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 numberISRCTN86234930; Pre-results.

A systematic review of heart failure dyadic self-care interventions focusing on intervention components, contexts, and outcomes

“…The three remaining studies examined decision aids; (McIlvennan et al, 2015) family education; (Deek et al, 2015) a multi-component trial comprised of a bathroom scale, decision aid, education and discharge summary to the primary care provider. (Demers et al, 2014) Finally, the protocol paper described a health professional facilitated, home-based, rehabilitation intervention (Taylor et al, 2015). Taken together the ongoing studies appear like the complete studies in numbers and types of components, contexts and outcomes measures.…”

“…Eight papers (six abstracts, (Bakitas et al, 2016;Deek et al, 2015;Demers et al, 2014;McIlvennan et al, 2015) one feasibility study, (DionneOdom et al, 2014) and one protocol paper (Taylor et al, 2015)) met the criteria of ongoing studies. We were unable to assess sufficient information on components, contexts, and outcomes to include them in our previous analyses.…”

Rehabilitation Enablement in Chronic Heart Failure—a facilitated self-care rehabilitation intervention in patients with heart failure with preserved ejection fraction (REACH-HFpEF) and their caregivers: rationale and protocol for a single-centre pilot randomised controlled trial

“…It is estimated that a total of 216 patients would be needed for a definitive trial to detect a clinically meaningful between group difference in the primary outcome of MLHFQ (for details of this sample size calculation, see ref. 12 ). No sample size calculation has been applied to the caregiver participants.…”

“…12 The checklist is based on a Dreyfus Scale which has been used to assess clinical competence in the delivery of psychological therapies, 42 as well as in other self-care behaviour interventions. 43 All contacts (telephone and face to face) between intervention facilitators and six purposively sampled patient will be audio recorded by intervention facilitators and then reviewed and coded (using the fidelity checklist) by two independent researchers.…”

“…11 The Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) programme of research was designed to develop and evaluate a health professional facilitated home-based self-help rehabilitation intervention to improve self-care and HRQoL in people with HF and their caregivers. 12 A core element of the REACH-HF intervention is exercise training which will be invested to better understand the mechanisms by which exercise intervention can improve exercise tolerance in HFpEF. In HFrEF patients, exercise intervention has been shown to improve cardiorespiratory fitness though cardiac 13 14 and extra cardiac mechanisms.…”