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A randomised controlled trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers: the REACH-HFpEF Pilot Study
  1. Chim C Lang1,
  2. Karen Smith1,2,
  3. Jennifer Wingham3,4,
  4. Victoria Eyre5,
  5. Colin J Greaves3,
  6. Fiona C Warren3,
  7. Colin Green3,
  8. Kate Jolly6,
  9. Russell C Davis7,
  10. Patrick Joseph Doherty8,
  11. Jackie Miles9,
  12. Nicky Britten3,
  13. Charles Abraham3,
  14. Robin Van Lingen10,
  15. Sally J Singh11,
  16. Kevin Paul12,
  17. Melvyn Hillsdon13,
  18. Susannah Sadler3,
  19. Christopher Hayward14,
  20. Hayes M Dalal3,4,
  21. Rod S Taylor3
  22. and on behalf of the REACH-HF investigators,
  1. 1 School of Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK
  2. 2 School of Nursing and Health Sciences, University of Dundee, Dundee, UK
  3. 3 Institute of Health Research, University of Exeter Medical School, Exeter, UK
  4. 4 Research, Development and Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK
  5. 5 Re-Cognition Health, Plymouth, UK
  6. 6 Institute for Applied Health Research, University of Birmingham, Birmingham, UK
  7. 7 Cardiology Department, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK
  8. 8 Department of Health Sciences, University of York, York, UK
  9. 9 Research and Development, Anuerin Bevan University Health Board, St Woolos Hospital, Newport, UK
  10. 10 Cardiology Department, Royal Cornwall Hospitals NHS Trust, Truro, UK
  11. 11 Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK
  12. 12 REACH-HF Patient and Public Involvement Group, c/o Research, Development & Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK
  13. 13 Sport and Health Sciences, University of Exeter, Exeter, UK
  14. 14 Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK
  1. Correspondence to Professor Chim C Lang; c.c.lang{at}dundee.ac.uk

Abstract

Introduction Home-based cardiac rehabilitation may overcome suboptimal rates of participation. The overarching aim of this study was to assess the feasibility and acceptability of the novel Rehabilitation EnAblement in CHronic Hear Failure (REACH-HF) rehabilitation intervention for patients with heart failure with preserved ejection fraction (HFpEF) and their caregivers.

Methods and results Patients were randomised 1:1 to REACH-HF intervention plus usual care (intervention group) or usual care alone (control group). REACH-HF is a home-based comprehensive self-management rehabilitation programme that comprises patient and carer manuals with supplementary tools, delivered by trained healthcare facilitators over a 12 week period. Patient outcomes were collected by blinded assessors at baseline, 3 months and 6 months postrandomisation and included health-related quality of life (primary) and psychological well-being, exercise capacity, physical activity and HF-related hospitalisation (secondary). Outcomes were also collected in caregivers.

We enrolled 50 symptomatic patients with HF from Tayside, Scotland with a left ventricular ejection fraction ≥45% (mean age 73.9 years, 54% female, 100% white British) and 21 caregivers. Study retention (90%) and intervention uptake (92%) were excellent. At 6 months, data from 45 patients showed a potential direction of effect in favour of the intervention group, including the primary outcome of Minnesota Living with Heart Failure Questionnaire total score (between-group mean difference −11.5, 95% CI −22.8 to 0.3). A total of 11 (4 intervention, 7 control) patients experienced a hospital admission over the 6 months of follow-up with 4 (control patients) of these admissions being HF-related. Improvements were seen in a number intervention caregivers' mental health and burden compared with control.

Conclusions Our findings support the feasibility and rationale for delivering the REACH-HF facilitated home-based rehabilitation intervention for patients with HFpEF and their caregivers and progression to a full multicentre randomised clinical trial to test its clinical effectiveness and cost-effectiveness.

Trial registration number ISRCTN78539530.

  • heart failure
  • heart failure with preserved ejection fraction
  • cardiac rehabilitation
  • randomised controlled trial
  • complex intervention
  • caregivers

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors The REACH-HFpEF pilot trial was designed by CCL, KS, HMD, RST, JW, KJ, RCD, PJD, JM, RVL, SJS, CA, NB, CJG, CG, KP, MH, SS and CH. KJ, RST, RCD and HMD developed the original idea for REACH-HFpEF. FCW and CG analysed the data. VE and CH were responsible for study and data collection management. CCL undertook the first draft of the manuscript that was then edited by JW, FCW, RST and HMD. All authors were involved in 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.

  • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests RST is the lead for the ongoing portfolio of Cochrane reviews of cardiac rehabilitation. RST and HMD are named Scientific Advisors for the ongoing National Institute of Health and Care Excellence (NICE) updated clinical guidelines for the management heart failure (CG108). HMD is an ordinary member of the British Association for Cardiovascular Prevention and Rehabilitation (BACPR) council. All other coauthors declare no conflict of interest.

  • Patient consent Obtained.

  • Ethics approval Scotland A Research Ethics Committee (ISRCTN57596739).

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

  • Data sharing statement The authors confirm that all data underlying the findings are fully available without restriction. The authors have made the clinical and economic data set available through the University of Exeter’s Institutional Repository, Open Research Exeter (see https://ore.exeter.ac.uk). Access to these data is permitted but controlled through requests made via the repository to the chief investigator (Professor Taylor: r.s.taylor @exeter.ac.uk). Although use is permitted, this will be on the basis that the source of the data is acknowledged (including the funder) and it includes reference to the data set ‘handle’.

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