Web-Based Group Conversational Intervention on Cognitive Function and Comprehensive Functional Status Among Japanese Older Adults: Protocol for a 6-Month Randomized Controlled Trial

Abstract

Background: Social communication is a key factor in maintaining cognitive function and contributes to well-being in later life.Objective: This study will examine the effects of "Photo-Integrated Conversation Moderated by Application version 2" (PICMOA-2), which is a web-based conversational intervention, on cognitive performance, frailty, and social and psychological indicators among community-dwelling older adults. Methods:The study is a randomized controlled trial (RCT) with an open-label, two-parallel group trial and 1:1 allocation design. Community dwellers aged 65 years and older were enrolled in the trial and divided into the intervention and control groups. The intervention group receives the PICMOA-2 program, a web-based group conversation, once every two weeks for six months. The primary outcome is verbal fluency, including phonemic and semantic fluency. The secondary outcomes are: 1) other neuropsychiatric batteries, including the Mini-Mental State Examination, logical memory (immediate/delay), and verbal paired associates, and comprehensive functional status evaluated by questionnaires including frailty, social status, and well-being. The effect of the intervention will be examined using a mixed linear model. As a secondary aim, we will test whether the intervention effects vary with the covariates at baseline to examine the effective target attributes.Results: Recruitment was completed in July 2023. A total of 66 participants were randomly allocated to intervention or control groups. As of 1st January 2024, the intervention is ongoing. Participants are expected to complete the intervention at the end of February 2024, and the post intervention evaluation will be conducted in March 2024. Conclusions:The current protocol outlines the RCT study design evaluating the effect of a 6-month intervention with PICMOA-2. This study will provide evidence on the effectiveness of social interventions on cognitive function and identify effective target images for remote social intervention. Clinical Trial: UMIN Clinical Trials Registry UMIN000050877.