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Randomized Controlled Trial
. 2025 Feb;6(2):100670.
doi: 10.1016/j.lanhl.2024.100670. Epub 2025 Feb 24.

Clinical and cost-effectiveness of a home-based health promotion intervention for older people with mild frailty in England: a multicentre, parallel-group, randomised controlled trial

Affiliations
Randomized Controlled Trial

Clinical and cost-effectiveness of a home-based health promotion intervention for older people with mild frailty in England: a multicentre, parallel-group, randomised controlled trial

Kate Walters et al. Lancet Healthy Longev. 2025 Feb.

Abstract

Background: Health promotion for people with mild frailty has the potential to improve health outcomes, but such services are scarce in practice. We developed a personalised, home-based, behaviour change, health promotion intervention (HomeHealth) and assessed its clinical effectiveness and cost-effectiveness in maintaining independent functioning in activities of daily living in older adults with mild frailty.

Methods: This trial was an individual, multicentre, parallel-group, randomised controlled trial done in England. Participants were mainly recruited from general practices in three different areas of England (the London north Thames region, east and north Hertfordshire, and west Yorkshire). Participants were individuals residing in the community who were registered with a general practice, 65 years and older with mild frailty (scoring 5 on the CFS), with a life expectancy of more than 6 months, and with capacity to consent to participate. We excluded adults residing in nursing or care homes, those with moderate-to-severe frailty or with no frailty, those receiving palliative care, and those already case managed (eg, receiving a similar ongoing intervention from the voluntary sector or community service). Eligible participants were randomly assigned 1:1 to either the HomeHealth intervention or to treatment as usual. HomeHealth is a multidomain health promotion intervention delivered by the voluntary sector at home in six sessions over 6 months. The primary outcome was independent functioning (assessed using the modified Barthel Index [BI]) at 12 months. Outcome assessments were masked and were analysed by intention to treat using linear mixed models. Incremental costs and quality-adjusted life-years (QALYs) were calculated using seemingly unrelated regression and bootstrapping. The trial is registered on the ISRCTN registry (ISRCTN54268283).

Findings: We recruited 388 participants between Jan 8, 2021 and July 2, 2022 (mean age 81 years, SD 6·5; 249 (64%) of 388 were women and 139 (36%) were men). 195 participants were randomly assigned to HomeHealth and 193 to treatment as usual. Median follow-up was 363 days (IQR 356-370) in the HomeHealth group and 362 days (IQR 355-373) in the treatment-as-usual group. HomeHealth did not improve BI scores at 12 months (mean difference 0·250, 95% CI -0·932 to 1·432). HomeHealth was superior to treatment as usual with a negative point estimate for incremental costs (-£796; 95% CI -2016 to 424) and positive point estimate for incremental QALYs (0·009, -0·021 to 0·039). There were 55 serious adverse events in the HomeHealth group and 85 in the treatment-as-usual group; none were intervention related.

Interpretation: HomeHealth is a safe intervention with a high probability of cost-effectiveness, driven by a reduction in unplanned hospital admissions. HomeHealth should be considered as a health promotion intervention for older people with mild frailty.

Funding: National Institute for Health Research Health Technology Assessment.

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Conflict of interest statement

Declaration of interests KW has received funding from National Institutes for Health Research (NIHR) programmes and is a member of the NIHR School of Public Health Research and NIHR Three Schools Prevention Advisory Boards. RF is Chair of the Study Steering Committee for the NIHR-funded CASCADE project and is Treasurer for the British Society of Gerontology (unpaid voluntary role). DAS is Director and holds shares in Later Life Training, a not-for-profit training organisation that delivers exercise delivery training to health and fitness professionals, which supported the exercise training programme for HomeHealth support workers included in the intervention. DAS has received funding as a Co-Investigator on grants funded by NIHR Applied Research Collaboration National Priority for Ageing, Dementia, and Frailty, Chief Scientists Office, UK Research and Innovation Public Health Intervention Development, European Commission (H2020-MSCA-ITN), Orthopaedic Research UK, and Singapore Physiotherapy Association. DAS is Chair of the British Geriatrics Society Rehabilitation Group, a member of the British Geriatrics Society Special Interest Group on Falls and Fractures, a member of the Scientific Advisory Board for the Older People and Frailty NIHR Policy Research Unit, is Chair of Academic Advisory Group, PACES Project, and the Medical Research Council funded project, University of Glasgow, and a member of the NIHR Advanced Fellowship Selection Committee. AC led the development and UK implementation of the electronic frailty index, which is licensed to suppliers of electronic health-record systems at no cost, on the basis a premium charge is not applied to the end UK National Health Service user. AC has received funding from NIHR, Dunhill Medical Trust, UK Research and Innovation, Geras Centre for Aging Research (2023 Centre Review), and Australia and New Zealand Society of Geriatric Medicine, and is Chair of global Ageing Research Trialists collaborative, member of National Institute for Health and Care Excellence Falls Prevention Guideline Development Group, and sits on Trial Steering Committee and Data Monitoring and Ethics Committee for NIHR trials. KK is a Trustee of Age UK Harrow, Hillingdon, and Brent (unpaid role). RE has received funding as Public Involvement Lead from Kings College London and is a member of the National Dignity Council. RH has received funding from AstraZeneca: advice on commissioning cardiovascular disease management in primary care. All other authors declare no competing interests.

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