Tailored implementation of multidomain intervention to prevent cognitive impairment in community-dwelling older adults (Timi-Cog): A study protocol for a hybrid type 2 trial effectiveness-implementation study - 13/06/26
, Dong (Roman) Xu c, 2, ⁎ , Ying Wang a, b, 2, ⁎
Bienvenido a EM-consulte, la referencia de los profesionales de la salud.
Artículo gratuito.
Conéctese para beneficiarse!
Abstract |
Background & Objectives |
Despite growing recognition of multidomain non-pharmaceutical interventions (NPIs) for preventing cognitive impairment, their scalable implementation remains underdeveloped in China. This hybrid type 2 effectiveness-implementation study aims to bridge this gap by identifying implementation determinants, developing tailored strategies, and evaluating both implementation or health outcomes for multidomain NPIs and tailored strategies.
Methods |
This protocol describes the design of an ongoing study. The formative phase has been completed: guided by Consolidated Framework for Implementation Research (CFIR), we integrated the COM-B model from the Behaviour Change Wheel (BCW) and the Theoretical Domains Framework (TDF) into an interview guide. Key informant interviews and focus groups identified barriers/facilitators, and the CFIR-ERIC matching tool finalized the implementation strategies. Subsequently, a hybrid type 2 cluster RCT will be conducted (or is currently underway) across 13 districts in Changxing County, Zhejiang. A total of 1170 older adults and 273 community health workers (CHWs) - including general practitioners, social workers, and volunteers - will be randomized into three study arms: Arm 1 will receive evidence-based practices (EBP) combined with intrinsic motivation; Arm 2, EBP with implementation strategies; and Arm 3 (control), health education with implementation strategies. The EBP package includes cardio-metabolic risk management, cognitive training, physical activity, and nutritional counseling. Implementation uses three bundles: (1) Capacity Building and Professional Support, (2) Collaborative Implementation and Network Building, and (3) an AI-enabled WeChat mini-program (Timi-Cog). Outcomes will be assessed using the Re -AIM framework over 18 months. Statistical analysis will employ mixed-effects linear models, adjusted for baseline characteristics and clustering effects.
Conclusions & Implications |
This theory-informed initiative addresses the dementia prevention implementation gap in China. By combining BCW/TDF frameworks with implementation science methods and employing a hybrid design, the study will generate robust evidence on both clinical effectiveness and practical implementation, informing the integration of multidomain NPIs into China’s primary care system.
Trial Registration |
Chinese Clinical Trial Registry (ChiCTR2500098587).
El texto completo de este artículo está disponible en PDF.Keywords : Cognitive impairment prevention, Older adults, Multidomain non-pharmaceutical intervention, Implementation science, Hybrid type 2 effectiveness-implementation trial
Abbreviations : Timi-Cog, AD, MCI, NPIs, FINGER, MAKS, cRCT, ADI, WHO, NCOs, CFIR, TDF, COM-B, ERIC, CHW, EBP, SPIRIT, StaRi, CONSORT, MMSE, ADL, IADL, PASE, MNA, GDS-15, GPs, CNA, AI, LLM, BMI, MDT, DASH, MIND, RPE, ICC, MoCA-B, CDR, CSQ-8, BARS, AVLT, LMT, TMT-A, TMT-B, DSST, DST, BNT, KAP, PSQI, PDI, SSRS, HRQoL, NIHR, NoMAD, PSS, SIAS-6, MFS, CTCAE, DMC, IRB, CI
Esquema
Vol 13 - N° 8
Artículo 100623- octobre 2026 Regresar al número
Artículo precedente
- Bidirectional causal relationships between plasma proteins, neuroimaging metrics and risk of Alzheimer's disease
- Xu Xu, Lintong Li, Wei Huang, Ying Yang, Xu Li, Pei Wang, Mengmeng Zhao, Huiliang Zhang, Chaoming Yuan
- The time interval from amyloid to tau PET positivity varies by age, sex and APOE-ε4 status
- Marta Milà-Alomà, Isabella Hausle, Kellen K. Petersen, Pamela Thropp, Suzanne E. Schindler, Duygu Tosun, Alzheimer’s Disease Neuroimaging Initiative
Bienvenido a EM-consulte, la referencia de los profesionales de la salud.