Abstract
Introduction: Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL), and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF but there is currently insufficient evidence to support its routine use. This trial will assess the clinical effectiveness and cost-effectiveness of a 12-week health professional facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers.
Methods and analysis: REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample of size of 520 participants with HFpEF and their caregivers recruited from secondary care centres in England, Scotland, and Wales. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline, 4- and 12-months follow up. The primary outcome measure will be patients’ disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include exercise capacity, psychological wellbeing, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, survival, hospitalisations and other adverse events, and perceived burden on caregivers. A process-evaluation and sub-study will assess the fidelity of intervention delivery and adherence to home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators’ experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year (QALY) at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services (PSS) perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.
Ethics and dissemination: The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users, and policymakers.
Trial registration number: ISRCTN47894539.
Methods and analysis: REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample of size of 520 participants with HFpEF and their caregivers recruited from secondary care centres in England, Scotland, and Wales. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline, 4- and 12-months follow up. The primary outcome measure will be patients’ disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include exercise capacity, psychological wellbeing, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, survival, hospitalisations and other adverse events, and perceived burden on caregivers. A process-evaluation and sub-study will assess the fidelity of intervention delivery and adherence to home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators’ experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year (QALY) at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services (PSS) perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.
Ethics and dissemination: The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users, and policymakers.
Trial registration number: ISRCTN47894539.
| Original language | English |
|---|---|
| Number of pages | 14 |
| Journal | BMJ Open |
| Volume | 15 |
| Issue number | 5 |
| Early online date | 27 May 2025 |
| DOIs | |
| Publication status | Published - May 2025 |
Keywords
- Heart Failure
- Preserved Ejection Fraction
- Rehabilitation
- Self-care
- Diastolic dysfunction
