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Randomized Controlled Trial
. 2018 Apr 9;8(4):e019649.
doi: 10.1136/bmjopen-2017-019649.

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

Chim C Lang  1 , Karen Smith  1   2 , Jennifer Wingham  3   4 , Victoria Eyre  5 , Colin J Greaves  3 , Fiona C Warren  3 , Colin Green  3 , Kate Jolly  6 , Russell C Davis  7 , Patrick Joseph Doherty  8 , Jackie Miles  9 , Nicky Britten  3 , Charles Abraham  3 , Robin Van Lingen  10 , Sally J Singh  11 , Kevin Paul  12 , Melvyn Hillsdon  13 , Susannah Sadler  3 , Christopher Hayward  14 , Hayes M Dalal  3   4 , Rod S Taylor  3 ; REACH-HF investigators,
Affiliations
Randomized Controlled Trial

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

Chim C Lang et al. BMJ Open. .

Erratum in

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.

Keywords: cardiac rehabilitation; caregivers; complex intervention; heart failure; heart failure with preserved ejection fraction; randomised controlled trial.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials (CONSORT) flow chart.
Figure 2
Figure 2
Minnesota Living With Heart failure Questionnaire (MLHFQ) outcomes at baseline and at 4-month and 6-month follow-ups.
See this image and copyright information in PMC

References

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