Title: 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
Funder: Chief Scientist Office, Scotland

Abstract: OUR AIM: To find out whether a home-based rehabilitation programme in people with heart failure with preserved ejection fraction and their caregivers is effective and cost-effective._x000D_ _x000D_ WHY THIS RESEARCH IS IMPORTANT: Half of all people with heart failure have heart failure with preserved ejection fraction (or ‘HFpEF’). HFpEF is a complex condition of the heart that affects older individuals who typically have a number of concomitant diseases, including diabetes and high blood pressure. HFpEF has severe impacts on both patients and healthcare systems, including: a markedly reduced ability to undertake activities of daily living, greatly reduced quality of life, and highly increased risk of unplanned hospital admissions, resulting in high NHS costs. Drug and device therapies shown to work in people with the other type of heart failure (heart failure with reduced ejection fraction) do not work in HFpEF. As a result, the 400,000 patients in the UK who have HFpEF are effectively living with untreated heart failure, with potentially devastating consequences for themselves and their families._x000D_ With prior National Institute for Health Research funding, we designed a home-based rehabilitation intervention to promote physical and mental wellbeing and support self-management for people with heart failure and their caregivers: ‘REACH-HF’. In a pilot study of 50 patients and their caregivers, we showed that people with HFpEF are willing to participate in this type of research and that they engaged well with the REACH-HF intervention. We also saw promising effects of REACH-HF captured by this quote from one of the pilot study participants: “…you should not underestimate the importance of this as a positive intervention for HFpEF patients and their caregivers”. A recent systematic review (of 8 small pilot trials of short duration) supports our pilot findings of a potential clinically important effect of exercise-based rehabilitation for HFpEF. However, due to the lack of strong evidence of its effectiveness or cost-effectiveness, our recent national survey shows cardiac rehabilitation is not currently available for this group of patients. So, this study will undertake a ‘definitive trial’ to help inform the NHS as to whether REACH-HF should be rolled out for people with HFpEF._x000D_ _x000D_ WHAT WE PLAN TO DO: 520 HFpEF patients (and their caregivers) will receive either REACH-HF plus usual care or usual care only. The main patient outcome will be a widely used quality of life measure: Minnesota Living with Heart Failure Questionnaire. Other patient outcomes include mental wellbeing, level of physical activity, hospital admissions, plus caregiver’s quality of life and burden. We will also assess how well the intervention is delivered, what factors may influence responsiveness to the intervention (e.g. patient age, severity of disease, education) and collect information on costs. Interviews with patients and caregivers will help us to inform NHS roll out if the trial is positive._x000D_ _x000D_ INVOLVEMENT OF PATIENTS AND CARERS: Patients and caregivers with lived experience of HFpEF have extensively been involved in the intervention development. A standing group of patients and carers is funded to provide advice during the trial._x000D_ _x000D_ SHARING OUR FINDINGS: We will use our extensive relationships with patient organisations, professional groups NHS commissioners and Health Boards, and the research community to share our findings widely.

Lay abstract: AIM_x000D_ 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._x000D_ _x000D_ METHODS_x000D_ Design: Multicentre parallel two group randomised (1:1 patient allocation) superiority trial with nested process and health economic evaluations and an internal pilot phase_x000D_ Participants: 520 patients with HFpEF and their caregivers._x000D_ _x000D_ Setting: 15 sites across England, Northern Ireland, Scotland, Wales._x000D_ _x000D_ 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. _x000D_ _x000D_ Control: Both intervention and control patients will receive usual medical care in accordance with European Society of Cardiology 2016 guidelines. _x000D_ Primary outcome: Minnesota Living with Heart Failure Questionnaire score at 12-months._x000D_ _x000D_ 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). _x000D_ _x000D_ Data analysis_x000D_ 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._x000D_ Economic evaluation: With-in trial cost-utility analysis over the 12-months._x000D_ Process evaluation: Case-based mixed methods analysis._x000D_ _x000D_ TIMETABLE_x000D_ Mar 2021-Aug 2021: Setup (approvals, site selection/recruitment, CRF/database development, patient identification); _x000D_ Sept 2021-Feb 2023: Screening/recruitment (Sept 2021-May 2022: 9-month internal pilot and months June 2022-Feb 2023: remaining recruitment completion) _x000D_ Jan 2022-June 2023: 4-month follow-up _x000D_ Sep 2022-Feb 2024:12-month follow-up_x000D_ Mar 2024-Aug 2024: Analysis, reporting, and dissemination._x000D_ _x000D_ EXPERTISE_x000D_ 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._x000D_ _x000D_ IMPACT_x000D_ 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.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.7 PHYSICAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: CARDIOVASCULAR