Clinical effectiveness and cost-effectiveness of a multicomponent frailty management program "Say No To Frailty" in Singapore: A cluster-randomized controlled trial protocol

Tianma Xu; Shawn Leng Hsien Soh; Chern-Pin Chua; Jutasompakorn Pearpilai; Shiou Liang Wee

doi:10.1016/j.cct.2024.107546

Clinical effectiveness and cost-effectiveness of a multicomponent frailty management program "Say No To Frailty" in Singapore: A cluster-randomized controlled trial protocol

Contemp Clin Trials. 2024 Apr 30:142:107546. doi: 10.1016/j.cct.2024.107546. Online ahead of print.

Authors

Tianma Xu¹, Shawn Leng Hsien Soh², Chern-Pin Chua², Jutasompakorn Pearpilai², Shiou Liang Wee²

Affiliations

¹ Health and Social Sciences Cluster, Singapore Institute of Technology, Singapore. Electronic address: tim.xu@singaporetech.edu.sg.
² Health and Social Sciences Cluster, Singapore Institute of Technology, Singapore.

PMID: 38697512
DOI: 10.1016/j.cct.2024.107546

Abstract

Background: A 12-week multicomponent frailty management program - Say No To Frailty (SNTF) consisting of interactive talks and fitness exercises led by a trained program leader has shown feasibility and positive health outcomes in community-living older adults with frailty and pre-frailty in Singapore. This study aims to evaluate the clinical- and cost-effectiveness of SNTF on physical functions, self-confidence, community participation, quality of life and fall reduction in the local community setting.

Methods: This study will use the cluster-randomization method to randomly allocate 12 participating centres into three arms. Centres under two intervention arms will conduct the same SNTF program but led by a program leader with different training backgrounds (an Allied Health Professional (AHP) v.s. a non-AHP), whereas centres under the control arm will continue their usual care without an additional intervention. Eligible participants at each participating centre will be recruited via the convenience sampling method in the community setting. Primary outcome measure (frailty level) and secondary outcome measures (e.g., physical functions, self-confidence, community participation, quality of life) will be conducted by the blinded assessors at baseline, immediate, 3 months and 9 months post-intervention. Fall data will be collected during the one-year study period. Outcomes between and within groups will be compared and analysed using STATA to evaluate the clinical effectiveness. Program costs and relevant healthcare costs during the follow-up phase will be recorded for cost-effectiveness analysis.

Conclusion: This study will provide significant insights into conducting SNTF for Singapore community-living older adults with frailty and pre-frailty on clinical- and cost-effectiveness. Australia New Zealand Clinical Trials Registry: ACTRN12621001673831.

Keywords: Cluster-randomized controlled trial; Community-based; Frailty; Older adults; Protocol; Singapore.