Abstract / Summary
IntroductionSMRUTHI-India (Strategic Multimodal Intervention in at-risk Elderly Indians for Prevention of Dementia), was initiated across rural India to establish a cohort of at-risk elderly for primary dementia prevention. Dementia prevalence being 7.4% and higher rates in rural areas, culturally tailored psychoeducational materials are essential. The current study thus aimed to construct and validate a multimodal intervention in elderly.MethodsA multimodal intervention “Care Bundle Module (CBM)” booklet was developed, followed by content validation. It was pilot tested for feasibility and preliminary intervention effects in hospital setting (central site) using cohort multiple randomised controlled trial (cmRCT) design. Using purposive sampling, some high-risk participants were also selected from periphery sites and intervention was conducted using pre-post design to assess feasibility, usability, and acceptability in community setting. Change in Lifestyle for Brain health (LIBRA) index was assessed. Simultaneously, a booklet containing ten themes was developed into thematic animated videos, and revised based on behavioural science expert feedback. CBM was assessed for understandability and actionability using Patient Education Material Assessment ToolPrint/Audio-Visual (PEMAT-P/AV).ResultsIntervention was developed in three languages (Hindi, Kannada, Bengali). In hospital setting and across periphery sites respectively, median (IQR) age was 61 (57, 66) years, mean age: 64.9 ± 5.8 years; median LIBRA: −4.6 (p = 0.02) and −1.0 (p = 0.001) (intervention arms). Rural setting showed higher recruitment and retention rates with good adherence. Between 70 to 96%, participants rated booklet and videos as well understandable and actionable on PEMAT.ConclusionCBM demonstrated high content validity, acceptability, and adherence across rural settings. This suggests feasibility to conduct multidomain interventions for at-risk elderly to foster healthy ageing.Clinical trial registrationhttps://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODYxODY=&Enc=&userName=, Identifier CTRI/2024/01/061172.