Abstract
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 .
DOI
10.1136/bmjopen-2016-012853
Publication Date
2016-10-01
Publication Title
BMJ Open
Volume
6
Issue
10
First Page
e012853
Last Page
e012853
ISSN
2044-6055
Organisational Unit
School of Nursing and Midwifery
Recommended Citation
Eyre, V., Lang, C., Smith, K., Jolly, K., Davis, R., Hayward, C., Wingham, J., Abraham, C., Green, C., Warren, F., Britten, N., Greaves, C., Doherty, P., Austin, J., Van, L., Singh, S., Buckingham, S., Paul, K., Taylor, R., & Dalal, H. (2016) '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', BMJ Open, 6(10), pp. e012853-e012853. Available at: https://doi.org/10.1136/bmjopen-2016-012853
