Improved HRQoL with home-based cardiac rehabilitation in HFrEF patients
The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial
Introduction and methods
Although group- or center-based cardiac rehabilitation is recommended to improve health-related quality of life (HRQoL) in patients with heart failure (HF) [1-3], less than 10% of American HF patients and 20% of European HF patients participate in cardiac rehabilitation [4,5]. Home-based cardiac rehabilitation programs can widen access and have been demonstrated to be as effective as group- or hospital-based cardiac rehabilitation after myocardial infarction and coronary revascularization, and with similar costs [6]. However, there is little evidence available with regard to clinical and cost-effectiveness of home-based cardiac rehabilitation in patients with HF [7] and none of the interventions have involved caregivers or have been co-developed with patients, caregivers or clinicians.
The Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) was a multicenter, two parallel group, randomized, superiority trial that assessed the effect of cardiac rehabilitation [8] for 12 weeks on top of usual care (n=107) versus usual care alone (n=109) on quality of life in patients aged ≥18 years with confirmed HFrEF on echocardiography or angiography within the preceding five years. Those who had undertaken cardiac rehabilitation within 12 months prior to enrolment, or with a contraindication to exercise testing or exercise training were excluded.
The home-based intervention included a mixture of face-to-face and telephone contacts over 12 weeks. Usual care was defined as medical management according to national and local guidelines, including specialist HF nurse care. Participants were stratified based on investigator site and baseline plasma N-terminal proB-type natriuretic peptide (BNP) levels (≤2 vs. >2 ng/ml).
The primary outcome was disease-specific HRQoL at 12 months measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Main results
Primary outcome
- REACH-HF intervention resulted in improved MLHFQ total scores at 12 months, while no difference in MLHFQ total scores was observed in the control group. There was a significant between-group difference in change from baseline of – 5.7 points (95%CI: –10.6 to –0.7, P=0.025), which was consistent across per-protocol, complier average causal effects, multiple-imputation and repeated-measure analyses.
- The REACH-HF group showed significantly better MLHFQ physical scores, compared with the control group (12.2 vs. 14.5) (mean difference at 12 months –3.2 [95%CI: –5.7 to –0.6, P=0.016]), whereas the MLHFQ emotional score did not (5.1 vs. 5.5) (–0.8 [95%CI:–2.2 to 0.6], P=0.273).
- More participants with REACH-HF intervention achieved a reduction of ≥5 MLHFQ points than participants with usual care (52% vs. 33%), as observed in a post-hoc analysis.
Secondary outcomes
- A difference in Self-Care of Heart Failure Index (SCHFI) maintenance score was observed at 12 months (REACH-HF: 63.8 vs. controls: 55.2), with a between-group difference of 8.0 (95%CI: 3.6 to 12.4, P<0.001).
- No significant changes were seen in HADS anxiety and depression, incremental shuttle walk test, SCHFI management and confidence, EQ5D, Heart Qol and physical activity between REACH-HF and control group at 12 months. Primary and secondary results were similar at four and six months.
- There was no significant subgroup treatment interaction on the primary outcome at 12 months by BNP level, presence of caregiver, recruitment site or duration of HF.
- In total eight (4%) participants died (four in REACH-HF and four in control group). Four deaths were related to HF (one in REACH-HF and three in control group) during the study period of 12 months.
- In the REACH-HF group, 19 participants had at least one hospital admission during follow-up, compared with 24 patients in the control group (OR: 0.72, 95%CI: 0.35 to 1.51, P=0.386). Overall, there were 33 admissions (4 related to HF) in the REACH-HF group and 35 (10 related to HF) in the control group. Three REACH-HF vs. six control patients had one or more hospital admissions related to HF (0.56, 95%CI: 0.13 to 2.33, P=0.422).
- The adverse events observed in the REACH-HF group were considered not to be related to the intervention.
Costs
- Taking into account the contact times, training, travel and consumables, the mean total cost for delivery of the REACH-HF intervention was estimated at 418.39 pound per participant.
Conclusion
This randomized trial showed superior and clinically important improvements in disease-specific HRQoL and self-management at 12 months with the affordable, novel REACH-HF home-based cardiac rehabilitation intervention for 12 weeks on top of standard care in HFrEF patients. Thus, this can be an additional option for patients, clinicians and healthcare commissioners to address current low rates of uptake of center-based cardiac rehabilitation.
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