The Evaluation of Interactive Cognitive Function Training Program (ICFTP) on Elders’ General Cognitive Functions, Executive Functions, and Vi Suo-Motor Abilities---A Randomized Controlled Study(3/3)

Title. The Evaluation of Interactive Cognitive Function Training Program (ICFTP) on Elders’ General Cognitive Function, Executive Function, and Visuo-Motor Abilities: A Randomized Controlled Study Background. Past studies have confirmed that interactive cognitive function training can effectively delay cognitive function decline in community-dwelling elderly. However, only 37% previous studies were randomized controlled trials (RCT). There are several gaps in the previous studies: limited generalizability, lack of long-term follow-up data as well as measurements of the functional impact of activities of daily living. For community-dwelling elders in this country, the effects of “Interactive Cognitive Function Training Program” (ICFTP) on cognitive function have not been specifically studied before. Objective. This study sought to investigate the effects of ICFTP on general cognitive function, executive function, and visuo-motor abilities in the community-dwelling elderly. Design. This study adopts a randomized controlled study with a 2-arm parallel group design. Study subjects are community-dwelling elderly. Subjects will be randomized by the permuted block randomization into experimental group (ICFTP), or active control group (Passive information activities, PIA). ICFTP trainings are divided into initial training session and booster training session. Both training sessions comprised 3 sessions of 45 minutes duration each week for 8 weeks (total 24 sessions). The active control group (PIA) receives only the initial training. The primary outcome parameter of this study is general cognitive function, assessed with Mini-Mental Status Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). The secondary outcomes are: 1) Executive function, assessed using the Executive Function Performance Task (EFPT), and the Instrumental Activities of Daily Living (IADLs); 2) Visuo-motor abilities, evaluated using the Berry-Buktenica Developmental Test of Visual-Motor Integration (Berry VMI). Data Analysis. Therapeutic adherence, sample attrition rate, medication compliance and adverse events will be monitored during the study period, and missing data analyzed using intent-to-treat analysis. Block-stratified Mantel-Haenszel Chi-square test (Categorical data) and blocked nonparametric linear rank test (Continuous data) will be used to test for differences in demographic data between the two groups. Latent growth curve modeling will be used in the repeated measures statistical analysis to estimate the causal effect of the intervention, and controlled the effect of the latent variables. General cognitive function, executive function, and visuo-motor abilities will be tested in the repeated measures analysis to show improvement and efficacy. For treatment efficacy over time, two groups will be compared before the intervention and during a follow-up, at 3 months, 6 months and 1 year after the intervention. Expected contribution. This wills be the first ICFTP program constructed targeting community-dwelling elderly in Taiwan. The study will adhere to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. Results of the current study will determine the value of ICFTP in Taiwanese elder population and provide valuable information for future utilization of this protocol.