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

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Authors

  • Chim C Lang
  • Karen Smith
  • Jennifer Wingham
  • Victoria Eyre
  • Fiona C Warren
  • Colin Green
  • Patrick Joseph Doherty
  • Jackie Miles
  • Nicky Britten
  • Charles Abraham
  • Robin Van Lingen
  • Sally J Singh
  • Kevin Paul
  • Melvyn Hillsdon
  • Susannah Sadler
  • Christopher Hayward
  • Hayes M Dalal
  • Rod S Taylor

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 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 and 6 months post-randomisation 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 heart failure patients 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% confidence interval: -22.8 to 0.3). A total of 11 (4 intervention, 7 control) patients experienced a hospital admission over the 6 months follow up with 4 (control patients) of these admissions being HF-related. Improvements were seen in a number intervention caregiver mental health and burden compared to 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 and cost-effectiveness.

Key words: Heart Failure, Heart Failure with Preserved Ejection Fraction, Cardiac Rehabilitation, Randomised Controlled Trial, Complex Intervention, Caregivers.

Trial registration number: ISRCTN78539530

Details

Original languageEnglish
Article numbere019649
JournalBMJ open
Volume8
Issue number4
Early online date9 Apr 2018
Publication statusPublished - 9 Apr 2018

Keywords

  • Heart Failure, Heart Failure with Preserved Ejection Fraction, Cardiac Rehabilitation, Randomised Controlled Trial, Complex Intervention, Caregivers