Taylor, Rod and Burrell, Emma and O’Hare, Claire and Thomson, Elizabeth and Placzek, Anna and Bollen, Jessica and Cleland, John G.F. and Cowie, Ansley and Dalal, Hasnain and Deaton, Christi and Doherty, Patrick and Dudman, Katie and Fraser, Heather and Frost, Julia and Greaves, Colin J. and Hartshorne-Evans, Nick and Hillsdon, Melvyn and Ibbotson, Tracy and Jarallah, Mohammad and Jolly, Kate and McConnachie, Alex and McIntosh, Emma and Smith, Valerie and Squire, Iain and Taylor, Louise and van Beurden, Sam and Lang, Chim C. and REACH-HFpEF investigators (2025) Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial. BMJ Open, 15 (5): e094254. ISSN 2044-6055

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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 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 size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month 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 patient's exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver's HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the 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 at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services 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.

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