Clinical effectiveness and cost-effectiveness of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) facilitated self-care rehabilitation intervention in heart failure patients and caregivers: rationale and protocol for a multicentre randomised controlled trial

• Published in: BMJ open Vol. 5; no. 12; p. e009994
• Main Authors: Taylor, R S, Hayward, C, Eyre, V, Austin, J, Davies, R, Doherty, P, Jolly, K, Wingham, J, Van Lingen, R, Abraham, C, Green, C, Warren, FC, Britten, N, Greaves, C J, Singh, S, Buckingham, S, Paul, K, Dalal, H
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01-01-2015; BMJ Publishing Group
• Subjects: Activities of daily living; Adolescent; Adult; Aged; Aged, 80 and over; Cardiovascular Medicine; Caregivers; Chronic Disease; Clinical Protocols; Cost analysis; Cost-Benefit Analysis; Ethics; Exercise; Expenditures; Female; Follow-Up Studies; Heart failure; Heart Failure - economics; Heart Failure - rehabilitation; Humans; Hypotheses; Intervention; Male; Medicin och hälsovetenskap; Middle Aged; Patients; Physical fitness; Quality of Life; Rehabilitation; Self Care - economics; Self Care - methods; Self help; Single-Blind Method; Studies; Treatment Outcome; United Kingdom; Young Adult; United Kingdom > UK; REHABILITATION MEDICINE
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2015-009994

IntroductionThe Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) trial is part of a research programme designed to develop and evaluate a health professional facilitated, home-based, self-help rehabilitation intervention to improve self-care and health-related quality of life in people with heart failure and their caregivers. The trial will assess the clinical effectiveness and cost-effectiveness of the REACH-HF intervention in patients with systolic heart failure and impact on the outcomes of their caregivers.Methods and analysisA parallel two group randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) in 216 patients with systolic heart failure (ejection fraction <45%) and their caregivers. The intervention comprises a self-help manual delivered by specially trained facilitators over a 12-week period. The primary outcome measure is patients’ disease-specific health-related quality of life measured using the Minnesota Living with Heart Failure questionnaire at 12 months’ follow-up. Secondary outcomes include survival and heart failure related hospitalisation, blood biomarkers, psychological well-being, exercise capacity, physical activity, other measures of quality of life, patient safety and the quality of life, psychological well-being and perceived burden of caregivers at 4, 6 and 12 months’ follow-up. A process evaluation will assess fidelity of intervention delivery and explore potential mediators and moderators of changes in health-related quality of life in intervention and control group patients. Qualitative studies will describe patient and caregiver experiences of the intervention. An economic evaluation will estimate the cost-effectiveness of the REACH-HF intervention plus usual care versus usual care alone in patients with systolic heart failure.Ethics and disseminationThe study is approved by the North West—Lancaster Research Ethics Committee (ref 14/NW/1351). Findings will be disseminated via journals and presentations to publicise the research to clinicians, commissioners and service users.Trial registration numberISRCTN86234930; Pre-results.