A randomised controlled trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers: the REACH-HFpEF Study

AIM To assess the clinical effectiveness and cost-effectiveness of home-based cardiac rehabilitation programme ‘REACH-HF’ plus usual care (intervention) versus usual care alone (control) in heart failure with preserved ejection fraction (HFpEF) patients and their caregivers. METHODS Design: Multicentre parallel two group randomised (1:1 patient allocation) superiority trial with nested process and health economic evaluations and an internal pilot phase Participants: 520 patients with HFpEF and their caregivers. Setting: 15 sites across England, Northern Ireland, Scotland, Wales. Intervention: REACH-HF is a comprehensive home-based cardiac rehabilitation (CR) and self-management programme informed by evidence, theory, and service users. It comprises the ‘Heart Failure Manual’, a Relaxation CD, a choice of exercise (walking programme or a chair-based exercise DVD), a ‘Progress Tracker’ tool for patients, and a ‘Family and Friends Resource’ for caregivers. Participating patients and caregivers work through the manual over a 12-week period with facilitation by a trained healthcare professional (e.g., heart failure specialist nurse, CR nurse or physiotherapist) using both face-to-face and telephone support. Given the COVID-19 pandemic, we have repurposed the REACH-HF intervention so that it can be delivered entirely remotely through telephone and web-based (where available) contact between healthcare staff and patients/caregivers. A digital version of REACH-HF is currently being developed that we anticipate will be available from Q4 2021. Control: Both intervention and control patients will receive usual medical care in accordance with European Society of Cardiology 2016 guidelines. Primary outcome: Minnesota Living with Heart Failure Questionnaire score at 12-months. Secondary outcomes: Deaths and hospital admissions; blood-borne biomarker; exercise capacity; physical activity levels; psychological well-being; generic quality of life; frailty; self-care; self-efficacy. Caregivers: burden, generic quality of life, psychological well-being; Collected at baseline (pre-randomisation), and 4 and 12-month post-randomisation. With the COVID-19, we anticipate collecting patient and caregiver outcome data by mail-based or online questionnaire and phone call follow up (as opposed to clinic visits). Data analysis Statistics: Main analysis will take an intention-to-treat approach (based on complete data at 6-months). For continuous outcome measures, we will use mixed-effects regression with a random effect of recruiting site and adjusting for baseline outcome score and minimisation variables. Economic evaluation: With-in trial cost-utility analysis over the 12-months. Process evaluation: Case-based mixed methods analysis. TIMETABLE Mar 2021-Aug 2021: Setup (approvals, site selection/recruitment, CRF/database development, patient identification); Sept 2021-Feb 2023: Screening/recruitment (Sept 2021-May 2022: 9-month internal pilot and months June 2022-Feb 2023: remaining recruitment completion) Jan 2022-June 2023: 4-month follow-up Sep 2022-Feb 2024:12-month follow-up Mar 2024-Aug 2024: Analysis, reporting, and dissemination. EXPERTISE Multidisciplinary research team: established track record in the successful delivery of complex intervention pragmatic trials with expertise in cardiology, rehabilitation, clinical trial design, behaviour change, biostatistics, health economics, process evaluation, and patient and public involvement. IMPACT Given their high unmet need for effective and cost-effective therapies, if positive, the findings of this trial have the potential to fundamentally impact the outcomes of HFpEF patients and their caregivers. Results will shared widely in order to inform future national and international guidelines and provide guidance to health professionals and healthcare commissioners on the need for rehabilitation and how to deliver it efficiently and effectively.