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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

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

Trial registration number ISRCTN78539530; Pre-results .

  • Preserved Ejection Fraction
  • Cardiac Rehabilitation
  • Randomised Controlled Trial
  • Complex Intervention
  • Caregivers

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Footnotes

  • Contributors The REACH-HFpEF pilot trial was designed by CCL, KS, HMD, RST, JW, KJ, RD, PD, JA, RVL, SS, CA, NB, CG, CJG, KP and SB. KJ, RST, RD and HMD developed the original idea for REACH-HFpEF. CCL, KS, HMD, RST, KJ and RD developed the protocol for the mechanistic substudy elements. VE undertook the first draft of the manuscript that was then edited by CH, RST and HMD. All authors provided critical evaluation and revision of the manuscript and have given final approval of the manuscript accepting responsibility for all aspects.

  • Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG-1210-12004). NB, CA, CJG and RST are also supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust; KJ by CLAHRC West Midlands and SS by CLAHRC East-Midlands. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: RST is the lead for the ongoing portfolio of Cochrane reviews of cardiac rehabilitation. RST and HMD are named topic specific experts for the NICE clinical guidelines update in heart failure. HD is an ordinary member of the British Association for Cardiovascular Prevention and Rehabilitation (BACPR) council.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Individual participant data will be made available as soon as reasonably possible after the end of the research project on a controlled access basis. Data requesters may make an application to the corresponding author for access to the data, with supporting documentation describing proposal for use. Any access granted will be subject to a Data Use Agreement.

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