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Optimizing a complex intervention for community-dwelling frail older adults: a factorial randomized trial within the multiphase optimization strategy framework [with consumer summary]
Sun X, Gao Y, Song J, Liu W, Li L, Sun H, Zhang W, Wu IXY
International Journal of Nursing Studies 2025 Nov;171:105181
clinical trial
This trial has not yet been rated.

BACKGROUND: The effectiveness of resistance exercise in improving frailty among community-dwelling frail older adults has been well-proved. However, poor adherence has threatened its effectiveness. OBJECTIVE: To optimize a previously developed complex intervention to enhance its efficiency and disseminability. DESIGN: 2 x 2 x 2 full factorial randomized trial. SETTINGS: This study was conducted at five community health service centers in Hunan Province, China. PARTICIPANTS: A total of 114 pre-frail or frail community-dwelling older adults. METHODS: Participants were randomly assigned to one of eight intervention groups (corresponding to all possible combinations of the three implementation components of goal setting, feedback and reinforcement guidance) to receive a 12-week intervention, with all receiving the core intervention (group elastic-band resistance exercise and community education). Outcomes were measured at baseline, 6 weeks, and 12 weeks. Primary outcomes included frailty and resistance exercise adherence. Mean difference (MD) and 95% confidence interval (CI) were calculated to estimate effectiveness using a linear mixed-effects model. Intervention costs were assessed from the viewpoint of service providers (community organizations and research teams). RESULTS: The goal-setting on group exhibited statistical significance in improving frailty (week 6: MD -0.25, 95% CI -0.47 to -0.02) and resistance exercises adherence (week 6: MD 6.37, 95% CI 2.40 to 10.30; week 12: MD 6.42, 95% CI 2.45 to 10.40). No statistically significant differences were found among the other implementation component groups. Compared to other implementation components, goal setting demonstrated superior implementation. The total intervention cost was 41,072.00 Chinese yuan, among which the goal-setting was 4560.00 Chinese yuan. CONCLUSION: The optimized intervention identified in this study, which combines group elastic-band resistance exercise with community-based education and goal-setting, is expected to facilitate the delivery of an efficient, effective, and disseminable intervention for frail older adults in community settings. REGISTRATION: chictr.org.cn (No. ChiCTR2300070392). Registration date: 11 April, 2023. First recruitment date: 21 April, 2023.
With permission from Excerpta Medica Inc.

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