Abstract
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 set-ting/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.