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 TRIAL
PUBLIC SUMMARY
OUR AIM:
To find out whether (and how) a home-based rehabilitation programme in people with heart failure with preserved ejection fraction and their caregivers is effective and cost-effective.
WHY THIS RESEARCH IS IMPORTANT:
About 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.
With prior National Institute for Health Research (NIHR) 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 randomised 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.
Recent systematic reviews and meta-analyses support 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, cardiac rehabilitation is not routinely recommended 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 to people with HFpEF.
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: the Minnesota Living with Heart Failure Questionnaire. Other outcomes include patients’ mental wellbeing, level of physical activity and hospital admissions, plus caregivers’ 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.
INVOLVEMENT OF PATIENTS AND CARERS:
Patients and caregivers with lived experience of HFpEF have been involved extensively in the intervention development. A standing Patient and Public Involvement (PPI) group of patients and carers will provide advice during the trial.
Scientific abstract
Trial Operational Group (TOG)
Project Management Group (PMG)
Trial sites
Patients, caregivers and their families
Patient and Public Involvement Group (PPI)
Trial Steering Committee (TSC) & Data Monitoring Committee (DMC)
Affiliated studies
Contact information
Conferences and presentations
Newsletters
Study protocol
British Society for Heart Failure Investigators Network Research Meeting
