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

V Eyre, CC Lang, K Smith, K Jolly, R Davis, C Hayward, J Wingham, C Abraham, C Green, FC Warren, N Britten, CJ Greaves, P Doherty, J Austin, Lingen R Van, S Singh, S Buckingham, K Paul, RS Taylor, HM Dalal

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Abstract

<jats:sec><jats:title>Introduction</jats:title><jats:p>The 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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>A 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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The 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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="http://www.isrctn.com/ISRCTN78539530?q=78539530&amp;filters=&amp;sort=&amp;offset=1&amp;totalResults=1&amp;page=1&amp;pageSize=10&amp;searchType=basic-search" ext-link-type="uri">ISRCTN78539530</jats:ext-link>; Pre-results .</jats:p></jats:sec>
Original languageEnglish
Pages (from-to)e012853-e012853
Number of pages0
JournalBMJ Open
Volume6
Issue number10
Early online date25 Oct 2016
DOIs
Publication statusPublished - Oct 2016

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