Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Oct 25;6(10):e012853.
doi: 10.1136/bmjopen-2016-012853.

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  1 , C C Lang  2 , K Smith  2   3 , K Jolly  4 , R Davis  5 , C Hayward  6 , J Wingham  6   7 , C Abraham  8 , C Green  6 , F C Warren  6 , N Britten  6 , C J Greaves  6 , P Doherty  9 , J Austin  10 , R Van Lingen  11 , S Singh  12 , S Buckingham  6 , K Paul  13 , R S Taylor  6 , H M Dalal  6   7 ; REACH-HF investigators
Affiliations
Randomized Controlled Trial

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 et al. BMJ Open. .

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 .

Keywords: Cardiac Rehabilitation; Caregivers; Complex Intervention; Preserved Ejection Fraction; Randomised Controlled Trial.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Consort flow chart.
See this image and copyright information in PMC

References

    1. Bhatia RS, Tu JV, Lee DS et al. Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med 2006;355:260–9. 10.1056/NEJMoa051530 - DOI - PubMed
    1. Owan TE, Hodge DO, Herges RM et al. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med 2006;355:251–9. 10.1056/NEJMoa052256 - DOI - PubMed
    1. Lam CSP, Donal E, Kraigher-Krainer E et al. Epidemiology and clinical course of heart failure with preserved ejection fraction. Eur J Heart Fail 2011;13:18–28. 10.1093/eurjhf/hfq121 - DOI - PMC - PubMed
    1. Liao L, Anstrom KJ, Gottdiener JS et al. Long-term costs and resource use in elderly participants with congestive heart failure in the Cardiovascular Health Study. Am Heart J 2007;153:245–52. 10.1016/j.ahj.2006.11.010 - DOI - PubMed
    1. Kitzman DW, Little WC, Brubaker PH et al. Pathophysiological characterization of isolated diastolic heart failure in comparison to systolic heart failure. JAMA 2002;288:2144–50. - PubMed

Publication types