A facilitated home-based cardiac rehabilitation intervention for people with heart failure and their caregivers: a research programme including the REACH-HF RCT

Abstract

Background: Rates of participation in centre- (hospital-) based cardiac rehabilitation (CR) by patients with heart failure (HF) are suboptimal. HF has two main phenotypes differing in underlying pathophysiology: HF with reduced ejection fraction (HFrEF) is characterised by depressed left ventricular systolic function (‘reduced ejection fraction’) and HF with preserved ejection fraction (HFpEF) is diagnosed after excluding other causes of dyspnoea with normal ejection fraction. This programme aimed to develop and evaluate a facilitated home-based CR intervention that could increase uptake of CR while delivering the clinical benefits of centre-based CR. Objectives: • To develop an evidence-informed, home-based, self-care CR programme for patients with HF and their caregivers (‘the REACH-HF intervention’) • To conduct a pilot randomised controlled trial (RCT) to assess the feasibility of a full trial of the effectiveness and cost-effectiveness of the REACH-HF intervention in addition to usual care in patients with HFpEF • To assess the short- and long-term effectiveness and cost-effectiveness of the REACH-HF intervention in addition to usual care in patients with HFrEF and their caregivers Design: Intervention mapping to develop the REACH-HF intervention; uncontrolled feasibility study; pilot RCT in HFpEF; RCT with trial-based cost-effectiveness analysis in HFrEF; qualitative studies including process evaluation; systematic review of CR in HF; and modelling to assess long-term cost20 effectiveness (in HFrEF). Setting: Four centres in United Kingdom (UK) (Birmingham, Cornwall, Gwent, and York) for main RCT; one centre in Dundee for pilot RCT. Participants: Adults aged ≥18 years with HFrEF (left ventricular ejection fraction (LVEF) <45%) for main RCT (n=216) and HFpEF (LVEF >45%) for pilot RCT (n=50). Intervention: Self-care, facilitated CR manual offered to patients (and participating caregivers) at home over 12 weeks by trained healthcare professionals in addition to usual care or usual care alone. Main outcome measures: The primary outcome was disease-specific health-related quality of life (HRQoL) measured using Minnesota Living with Heart Failure Questionnaire (MLHFQ) at 12 months. Secondary outcomes included deaths and hospitalisations.

Results: Main RCT recruited 216 participants with HFrEF and 97 caregivers. A significant and clinically meaningful between-group difference in MLHFQ score (primary outcome) at 12 months (–5.7 points [95% confidence interval (95% CI) –10.6 to –0.7]) favoured the REACH-HF intervention (p=0.025). Eight (4%) patients (four in each group) had died at 12 months. There was no significant difference in hospital admissions at 12 months, with 19 participants in REACH-HF group having at least one hospital admission compared with 24 in control group (odds ratio 0.72 (0.35 to 1.51), p=0.386). Mean cost of the intervention was £418 per participant with HFrEF; costs at 12 months were on average £401 higher compared with usual care alone. Model-based economic evaluation, extrapolating from the main RCT in HFrEF over 4 years, found that adding the REACH-HF intervention to usual care had an estimated mean cost per participant of £15,452 (£14,240 to £16,780) and mean quality-adjusted life-year (QALY) gain of 4.47 (3.83 to 4.91) compared with £15,051 (£13,844 to £16,289) and 4.24 (4.05 to 4.43), respectively, with usual care alone, giving an incremental cost per QALY of £1,721. Probabilistic sensitivity analysis indicated 78% probability that the intervention plus usual care versus usual care alone has a cost-effectiveness below the willingness-to-pay threshold of £20,000 per QALY gained. The intervention was well received by participant with HFrEF and HFpEF and their caregivers. Both RCTs recruited to target, with >85% retention at follow-up. Limitations: Key limitations included: (1) lack of blinding – given the nature of the intervention and control, we could not mask participant to treatments, so our results may reflect participant expectation bias; (2) we were not able to capture consistent participant-level data on level of intervention adherence; (3) generalisability of findings may be impacted by the demographics of the trial patients as most were male (78%), and we only recruited seven people from ethnic minorities. Conclusions: Evaluation of the comprehensive, facilitated, home-based REACH-HF intervention for participants with HFrEF and caregivers indicated clinical effectiveness in terms of HRQoL and patient self-care but no other secondary outcomes. While the economic analysis conducted alongside the full RCT did not produce significant differences on EQ-5D or QALYs, economic modelling suggested greater cost-effectiveness of the intervention against usual care. Our REACH-HF intervention offers a new evidence-based CR option that could increase uptake of CR in patients with HF not attracted to or able to access hospital-based programmes. Future work: Systematic collection of real-world data would track future changes in uptake of and adherence with alternative CR interventions in HFrEF and increase understanding of how changes in

service delivery might affect clinical and health economic outcomes. Findings of our pilot RCT in patients with HFpEF support progression to a full multicentre RCT. Study registration: Trial registration numbers are ISRCTN86234930 and ISRCTN78539530.