Multimodal Care Bundle Approach for Primary Prevention of Dementia in an Indian Cohort (SMRUTHI‐India)

Abstract Background The SMRUTHI‐India is a multimodal multisite intervention trial among the “at‐risk” elderly population of India, in a cohort randomized controlled manner for the prevention of Dementia. This study intends to introduce and present the conceptualization and formulation of the Care Bundle Module Booklet, which is designed to implement the strategic multimodal intervention for SMRUTHI‐India. Method The content of the Care Bundle Module Booklet was developed by the cross‐functional team, at AIIMS, New Delhi through a Preparatory, Acceptability, and Adaptability phase (Figure 1). The preparatory phase involved a detailed review of global ongoing studies on prevention of dementia. A multidisciplinary team prepared the content of the booklet focusing on Psychoeducation (Dementia – its signs and symptoms), Salient Modifiable Factors (Diabetes, Obesity, Hypertension, and Addiction), Protective Factors (diet intervention, physical exercises, and cognitive reserve), and information on context specific and culturally appropriate physical exercises, yoga sessions, dietary plan with pictorial examples and supplementary videos. In the Acceptability and Adaptability phase, feedback provided by local groups at individual sites was incorporated. The booklet was presented to experts for quantitative (Figure 2) and qualitative feedback, based on which Content Validity was inferred. The Content Validity of the intervention booklet was assessed using Item‐level content validity indices (I‐CVIs), Scale‐level CVI/Average, and Fleiss’s Multi‐rater Kappa indices. Result The S‐CVI/Average (Figure 3) was found to be 0.927 which indicates that 92.7 percent of the content in the booklet was judged valid and acceptable by 5 experts. Fleiss’s Multi‐rater kappa inferred that 2 items were judged “fair” and 20 items were judged “Excellent” by the experts on the feedback. The I‐CVI ranged between 0.6 to 1.0, where the items receiving scores less than 0.7 were modified before retaining. The items rated >0.7 and <1.0 were revised based on qualitative feedback. Conclusion The Care Bundle Module booklet has been conceptualized and formulated based on the expert’s feedback. Its compliance will be measured in the feasibility study, i.e. a 6‐month pilot study which will further assess the acceptability and adherence to the care bundle approach. Further process evaluation and changes will be implemented based on findings of the pilot study.