Home-based extended rehabilitation for older people with frailty (HERO): a multicentre randomised controlled trial with health economic analysis and process evaluation.

Background: Half of older people in hospital have frailty and are at increased risk of re-admission or death following discharge. Although short-term rehabilitation can reduce early re-admissions, benefits are attenuated over time. It is unknown whether extended rehabilitation for older people with frailty can improve outcomes. Trial design: Pragmatic, multicentre, individually randomised controlled parallel-group superiority trial with economic evaluation and embedded process evaluation. Methods: Participants: Eligible participants were 65 years or older with mild/moderate/severe frailty (score of 5-7 on Clinical Frailty Scale) admitted to hospital with acute illness or injury, then discharged home directly or from intermediate care (post-acute care) rehabilitation services. People with significant cognitive impairment and care home residents were among those ineligible. Recruitment took place from December 2017 to August 2021, with follow-up till August 2022. Interventions: Participants were randomly assigned (1.28 : 1) to the Home-based Older People's Exercise programme - a 24-week home-based manualised, progressive exercise intervention delivered by National Health Service therapists as extended rehabilitation, or usual care (control). Randomisation occurred after the participant had been discharged from hospital or intermediate care. Participants were not masked to allocation. Main outcome measures: The primary outcome was physical health-related quality of life, measured using the physical component score of the modified Short Form 36-item health questionnaire at 12 months. Secondary outcomes at 6 and 12 months included physical and mental health-related quality of life, functional independence, death, hospitalisations and care home admissions. Researchers involved in data collection were masked to allocation. Data sources: Primary and secondary outcomes were obtained via self-report questionnaire at 6 and 12 months. Hospitalisations and deaths were collected from routine healthcare data. Results: We randomised 740 participants (410 Home-based Older People's Exercise, 330 control) across 15 sites. Four hundred and seventy-nine (64.7%) participants completed 12-month follow-up. One hundred and eighty-eight Home-based Older People's Exercise participants (45.9%) completed 24 weeks of intervention delivery. Over half of participants completed more than 75% of prescribed exercises. Intention-to-treat analyses (258 Home-based Older People's Exercise participants, 208 control participants for primary outcome) showed no evidence that Home-based Older People's Exercise was superior to control for 12-month physical component score (adjusted mean difference -0.22, 95% confidence interval -1.47 to 1.03; <i>p</i> = 0.73). There was some evidence of a higher rate of all-cause hospitalisations in the control arm (incidence rate ratio 1.12, 95% confidence interval 1.00 to 1.25; <i>p</i> = 0.05), but no evidence of differences in other outcomes. The process evaluation found the intervention was largely delivered as intended and proved acceptable to most participants. The economic analysis showed incremental costs of Home-based Older People's Exercise plus usual care of GB£1401 (mean per participant), compared with usual care alone. There was a 0.024 quality-adjusted life-year improvement in Home-based Older People's Exercise compared to control. The incremental cost-effectiveness ratio was £58,375. Limitations: This trial was delivered during especially challenging circumstances that included the COVID-19 pandemic. We examined outcomes taking account of this but detected no difference in primary or secondary outcomes, providing reassurance that COVID-19 was unlikely to have influenced trial results. Conclusions: Based on our findings, we do not recommend routine commissioning of extended rehabilitation for older people with frailty after discharge home from hospital or intermediate care, following an acute admission with illness or injury. Future work: Future work should consider how existing core intermediate care and community rehabilitation services should be best organised and delivered to ensure that older people with frailty feel ready for discharge from rehabilitation, and are enabled to maintain their independence. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 15/43/07.