|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|
To assess the 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, Scotland, and Wales.
Intervention: REACH-HF is a comprehensive home-based cardiac rehabilitation (CR) and self-management programme informed by evidence, theory and service user perspective. 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 or rehabilitation physiotherapist) using both face-to-face support and telephone support.
Control: both intervention and control patients will receive usual medical care.
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; selfcare; self-efficacy. Caregivers: burden, generic quality of life, psychological well-being; Collected at baseline (pre-randomisation), and 4 and 12-month post-randomisation.
Economic evaluation: With-in trial cost-utility analysis over the 12-months.
Process evaluation: Case-based mixed methods analysis.
|Start date:||1st March 2021|
|End date:||31th August 2025|
|Contact person:||Professor Christi Deaton|
|Contact Details:||Primary Care Unit
East Forvie Building
|Funding Organisation:||National Institute for Health Research|
|Further Information, References and Publications|