Rehabilitation Enablement in Chronic Heart Failure—a facilitated self-care rehabilitation intervention in patients with heart failure with preserved ejection fraction (REACH-HFpEF) and their caregivers: rationale and protocol for a single-centre pilot randomised controlled trial

• Published in: BMJ open 2016-10, Vol.6 (10), p.e012853
• Main Authors: Eyre, V, Lang, C C, Smith, K, Jolly, K, Davis, R, Hayward, C, Wingham, J, Abraham, C, Green, C, Warren, F C, Britten, N, Greaves, C J, Doherty, P, Austin, J, Van Lingen, R, Singh, S, Buckingham, S, Paul, K, Taylor, R S, Dalal, H M
• Format: Article
• Language: English
• Subjects: Activities of daily living; Adolescent; Adult; Biomarkers; Blood pressure; Cardiac arrhythmia; Cardiology; Cardiovascular disease; Cardiovascular Medicine; Caregivers; Chronic Disease; Cost analysis; Data collection; Diabetes; Dyspnea; Ejection fraction; Exercise; Female; Fitness training programs; Heart attacks; Heart failure; Heart Failure - rehabilitation; Humans; Hypertension; Intervention; Male; Medical imaging; Mortality; Patients; Pilot Projects; Quality of Life; Rehabilitation; Research Design; Self Care; Stroke Volume
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2016-012853

IntroductionThe Rehabilitation EnAblement in CHronic Heart Failure in patients with Heart Failure (HF) with preserved ejection fraction (REACH-HFpEF) pilot trial is part of a research programme designed to develop and evaluate a facilitated, home-based, self-help rehabilitation intervention to improve self-care and quality of life (QoL) in heart failure patients and their caregivers. We will assess the feasibility of a definitive trial of the REACH-HF intervention in patients with HFpEF and their caregivers. The impact of the REACH-HF intervention on echocardiographic outcomes and bloodborne biomarkers will also be assessed.Methods and analysisA single-centre parallel two-group randomised controlled trial (RCT) with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention) or usual care alone (control) in 50 HFpEF patients and their caregivers. The REACH-HF intervention comprises a REACH-HF manual with supplementary tools, delivered by trained facilitators over 12 weeks. A mixed methods approach will be used to assess estimation of recruitment and retention rates; fidelity of REACH-HF manual delivery; identification of barriers to participation and adherence to the intervention and study protocol; feasibility of data collection and outcome burden. We will assess the variance in study outcomes to inform a definitive study sample size and assess methods for the collection of resource use and intervention delivery cost data to develop the cost-effectiveness analyses framework for any future trial. Patient outcomes collected at baseline, 4 and 6 months include QoL, psychological well-being, exercise capacity, physical activity and HF-related hospitalisation. Caregiver outcomes will also be assessed, and a substudy will evaluate impact of the REACH-HF manual on resting global cardiovascular function and bloodborne biomarkers in HFpEF patients.Ethics and disseminationThe study is approved by the East of Scotland Research Ethics Service (Ref: 15/ES/0036). Findings will be disseminated via journals and presentations to clinicians, commissioners and service users.Trial registration numberISRCTN78539530; Pre-results .