Abstract
Background: Health promotion for those with mild frailty has potential to improve outcomes, but there are few services. We developed a personalised, home-based behaviour change health promotion service (HomeHealth) and tested clinical and cost effectiveness in maintaining independent functioning in activities of daily living.
Methods: Individual parallel group randomised controlled trial in England. Participants were community-dwelling individuals aged 65+ years with mild frailty (scoring 5 on Clinical Frailty Scale), randomised 1:1 to receive HomeHealth or treatment as usual (TAU). HomeHealth is a multi-domain health promotion intervention delivered by the voluntary sector at home in six sessions over six months. Primary outcome was independent functioning (modified Barthel Index, BI) at 12 months. Outcome assessments were blinded 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.
Findings: We recruited 388 participants between January 2021–July 2022 (mean age 81years (SD 6.5); 249/388 (64.2%) women); 195 were randomised to HomeHealth. Median follow-up 363 days (IQR 356 to 370) in the HomeHealth and 362 days (IQR 355 to 372.5) in TAU arm. There were no intervention-related serious adverse events. HomeHealth did not improve BI scores at 12 months (Mean difference 0.250; 95%CI - 0.932, 1.432). HomeHealth dominates TAU with a negative point estimate for incremental costs (-£796; 95% CI -2016, 424) and positive point estimate for incremental quality adjusted life years (0.009; 95% CI-0.021, 0.039). There were 55 Serious Adverse Events in the HomeHealth arm and 85 in TAU arm, none were intervention-related.
Interpretation: HomeHealth was a safe, cost-effective intervention, driven by a
reduction in unplanned hospital admissions. It should be considered as a health
promotion intervention for older people with mild frailty.
Trial registration ISRCTN54268283
Funding: National Institute for Health Research (NIHR) Health Technology Assessment
(NIHR128334).
Methods: Individual parallel group randomised controlled trial in England. Participants were community-dwelling individuals aged 65+ years with mild frailty (scoring 5 on Clinical Frailty Scale), randomised 1:1 to receive HomeHealth or treatment as usual (TAU). HomeHealth is a multi-domain health promotion intervention delivered by the voluntary sector at home in six sessions over six months. Primary outcome was independent functioning (modified Barthel Index, BI) at 12 months. Outcome assessments were blinded 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.
Findings: We recruited 388 participants between January 2021–July 2022 (mean age 81years (SD 6.5); 249/388 (64.2%) women); 195 were randomised to HomeHealth. Median follow-up 363 days (IQR 356 to 370) in the HomeHealth and 362 days (IQR 355 to 372.5) in TAU arm. There were no intervention-related serious adverse events. HomeHealth did not improve BI scores at 12 months (Mean difference 0.250; 95%CI - 0.932, 1.432). HomeHealth dominates TAU with a negative point estimate for incremental costs (-£796; 95% CI -2016, 424) and positive point estimate for incremental quality adjusted life years (0.009; 95% CI-0.021, 0.039). There were 55 Serious Adverse Events in the HomeHealth arm and 85 in TAU arm, none were intervention-related.
Interpretation: HomeHealth was a safe, cost-effective intervention, driven by a
reduction in unplanned hospital admissions. It should be considered as a health
promotion intervention for older people with mild frailty.
Trial registration ISRCTN54268283
Funding: National Institute for Health Research (NIHR) Health Technology Assessment
(NIHR128334).
| Original language | English |
|---|---|
| Journal | The Lancet Healthy Longevity |
| Publication status | Accepted/In press - 26 Nov 2024 |
Keywords
- Frailty
- Cost-effectiveness
- health promotion
- older adults