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...
Overview
Authors
Affiliations
Introduction: The 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 Analysis: A 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 Dissemination: The 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 Number: ISRCTN86234930; Pre-results.
Exercise-based cardiac rehabilitation for adults with heart failure.
Molloy C, Long L, Mordi I, Bridges C, Sagar V, Davies E Cochrane Database Syst Rev. 2024; 3:CD003331.
PMID: 38451843 PMC: 10919451. DOI: 10.1002/14651858.CD003331.pub6.
Purcell C, Dibben G, Hilton Boon M, Matthews L, Palmer V, Thomson M Cochrane Database Syst Rev. 2023; 6:CD013820.
PMID: 37378598 PMC: 10305790. DOI: 10.1002/14651858.CD013820.pub2.
Dibben G, Hillsdon M, Dalal H, Tang L, Doherty P, Taylor R BMJ Open. 2023; 13(2):e063284.
PMID: 36759035 PMC: 9923308. DOI: 10.1136/bmjopen-2022-063284.
Mielke J, Brunkert T, Zuniga F, Simon M, Zullig L, de Geest S BMC Med Res Methodol. 2022; 22(1):320.
PMID: 36517765 PMC: 9749183. DOI: 10.1186/s12874-022-01772-w.
Why Do so Few People with Heart Failure Receive Cardiac Rehabilitation?.
Thompson D, Ski C, Clark A, Dalal H, Taylor R Card Fail Rev. 2022; 8:e28.
PMID: 36303590 PMC: 9585646. DOI: 10.15420/cfr.2022.16.