Cognitive Training RCT for Older Chinese Americans
- Conditions
- Cognitive HealthmHealth ApplicationCognitive TrainingExperience-based Co-designEthnogeriatrics
- Interventions
- Behavioral: Cognitive Training Intervention
- Registration Number
- NCT05355870
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to develop and pilot test a mHealth intervention for cognitive training that is culturally and linguistically relevant to older Chinese Americans
- Detailed Description
This is an NIH Stage 1 pilot randomized controlled trial. The purpose of this trial is to evaluate the feasibility, acceptability, and obtain preliminary effect sizes on outcomes of a cognitive training intervention. The cognitive training intervention will be app-based and will be co-developed with older Chinese Americans and adult children to ensure it is culturally and linguistically relevant.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 30
- self-identify as Chinese
- are age 60 or older
- are fluent in written and spoken Chinese and/or English
- have the visual capacity to read a smartphone or a tablet screen and have the auditory capacity to understand normal speech
- have no self-reported diagnosis of ADRD or cognitive impairment, and are capable of making an informed consent
- Individuals are excluded if they are bed-ridden
- receiving chemotherapy for malignancy
- have other life-threatening illnesses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Training Cognitive Training Intervention Participants in the experimental arm will be provided a brochure that included information on basic knowledge of ADRD, signs and symptoms related to ADRD, the definition and the potential benefits of cognitively stimulating activities in maintaining cognitive function, and examples of cognitively stimulating activities. Participants in this arm will complete a series of cognitive training exercises on a smartphone/tablet. The anticipated training will last for 12 weeks and involve 3-4 sessions per week (20-30 min/ session).
- Primary Outcome Measures
Name Time Method Feasibility as Measured by the status of study accrual Approximately 6 months Meeting the recruitment goal of 30 eligible participants in 6 months (Yes/No)
Feasibility as Measured by Adherence to Measurement Strategies at week 12 12 weeks The proportion of participants completing the 12-week assessments in both arms
Change in Global cognition as a composite measure of Mini-Mental State Examination(MMSE), Digit Span Test, verbal fluency, and the Trail Making Test Baseline, 8 weeks, 12 weeks A z-score of each test will be calculated and the average z-score that ranges from -1 to 1 will be used to measure global cognition, with higher score indicated better cognitive function
Feasibility as Measured by Study Adherence 12 weeks The proportion of participants in the intervention arm who successfully completing all intervention sessions
Feasibility as Measured by Adherence to Measurement Strategies at week 8 8 weeks The proportion of participants completing the 8-week assessments in both arms
Days of App use as Measured by the percentage of days that participants use the app Over the course of the intervention, 12 weeks The percentage of days that participants use the app for participants in the intervention arm over the course of study participation, with higher proportion indicated more days engaged in cognitive training
Acceptability as Measured by the Client Satisfaction Questionnaire 12 weeks The Client Satisfaction Questionnaire (CSQ) ranges from 8 to 32, with scores over the 80% suggested adequate acceptability
Duration of cognitive training as Measured by the average time to complete a cognitive exercise Over the course of the intervention, 12 weeks The average time in minutes to complete a cognitive exercise for participants in the intervention arm over the course of study participation, with longer duration indicated longer training
- Secondary Outcome Measures
Name Time Method Change in Loneliness as Measured by the University of California, Los Angeles three item Loneliness Scale Baseline, 8 weeks, 12 weeks The University of California, Los Angeles (UCLA) Loneliness Scale ranges from 3 to 9, with higher scores indicated greater degrees of loneliness
Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale Baseline, 8 weeks, 12 weeks The HADS - Anxiety Scale ranges from 0 to 21, with higher scores indicated greater degrees of anxiety
Change in Physical Functioning as Measured by the Activities of Daily Living and Instrumental Activities of Daily Living Scale Baseline, 8 weeks, 12 weeks Score ranges from 14 to 52, with higher scores indicated higher degree of physical functioning
Change in Depressive Symptoms as Measured by the Patient Health Questionnaire-9 Baseline, 8 weeks, 12 weeks PHQ-9 ranges from 0 to 27, with higher scores indicated greater depressive symptoms
Change in Quality of Life as Measured by the World Health Organization Quality of Life Instrument- Abbreviated Version (WHOQOL-BREF) Baseline, 8 weeks, 12 weeks The WHOQOL-BREF ranges from 0 to 100, with higher scores indicated better quality of life
Trial Locations
- Locations (1)
North Carolina (Participants Homes)
🇺🇸Durham, North Carolina, United States