Background: HomeHealth is a home-based, voluntary sector service supporting older people with mild frailty to maintain independence through behaviour change. Support workers discuss the person’s priorities and enable setting/achieving goals around mobility, nutrition, socialising and/or psychological well-being.Aims: We tested clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty in a randomised controlled trial.Methods: Design: Single-blind, parallel randomised controlled trial open between 18 January 2021 and 4 July 2023, with mixed-methods process evaluation.Setting: Community-dwelling older people aged 65+ years with mild frailty from 27 general practices and community settings in London, Yorkshire and Hertfordshire.Randomisation: Participants were randomised 1 : 1 to receive HomeHealth or treatment as usual.Outcomes: Primary outcome was independence in activities of daily living (modified Barthel Index), analysed using linear mixed models. Secondary outcomes included frailty phenotype score, extended activities of daily living, well-being, psychological distress, loneliness, cognition, falls and mortality. Health economic outcomes included quality of life, capability and service use, including hospital admissions. Cost-effectiveness acceptability curves and cost-effectiveness planes were used to represent the probability of cost-effectiveness compared to treatment as usual.Process evaluation: We conducted semistructured interviews with participants receiving the intervention, HomeHealth workers and other stakeholders supporting service delivery. Interviews were thematically analysed. Fidelity of audio-recorded appointments was assessed by two independent raters. We evaluated potential mechanisms of impact using data from appointments attended, types of goals set and progress towards goals.FindingsWe recruited 388 participants, mean age 81.4 years (standard deviation 6.5), 64% female and 94% White British/European. HomeHealth did not improve Barthel Index scores at 12 months (0.250, 95% confidence interval −0.932 to 1.432). At 6 months, we found small significant reductions in psychological distress (−1.237, 95% confidence interval −2.127 to −0.348), and frailty phenotype score (−0.252, 95% confidence interval −0.487 to −0.017). At 12 months, we found significant improvements in well-being (1.449, 95% confidence interval 0.124 to 2.775), reduced unplanned admissions (incidence rate ratio 0.65, 95% confidence interval 0.54 to 0.92) with lower associated costs (−£586/participant, 95% confidence interval −351 to −821). There were no differences in other outcomes. HomeHealth dominates treatment as usual with a negative point estimate for incremental costs (−796, 95% confidence interval −2016 to 424), positive point estimate for incremental quality-adjusted life-years (0.009, −0.021 to 0.039) and high probability of cost-effectiveness.Process evaluation: Sixty-four semistructured interviews were completed, including 49 participants and 15 HomeHealth workers/stakeholders. The service was acceptable and safe, with good fidelity of delivery. Participants made progress on personalised goals, most working on enhancing mobility. They found the service empowering, and received emotional/practical support. Engagement was more challenging when participants identified no need for change, had significant memory impairment or new/declining illness. Flexibility around varying symptoms and incorporating behaviour change into existing routines promoted engagement.ConclusionHomeHealth did not improve independent functioning for older people with mild frailty. There were small significant improvements in frailty status, psychological distress and well-being and a 35% reduction in unplanned admissions, with high probability of cost-effectiveness.LimitationsWe used a pragmatic design with intervention delivery in real-world settings during/after the COVID-19 pandemic, potentially with more variability in delivery. Our findings might not apply to other geographical settings/healthcare systems.FundingThis synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128334.
Walters et al. (Wed,) studied this question.