mHealth Cognitive Training Intervention Pilot for Older Chinese Americans
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cognitive Health
- Sponsor
- Duke University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Feasibility as Measured by the status of study accrual
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Individuals are excluded if they are bed-ridden
- •receiving chemotherapy for malignancy
- •have other life-threatening illnesses
Outcomes
Primary Outcomes
Feasibility as Measured by the status of study accrual
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale(Baseline, 8 weeks, 12 weeks)
- Change in Loneliness as Measured by the University of California, Los Angeles three item Loneliness Scale(Baseline, 8 weeks, 12 weeks)
- Change in Physical Functioning as Measured by the Activities of Daily Living and Instrumental Activities of Daily Living Scale(Baseline, 8 weeks, 12 weeks)
- Change in Depressive Symptoms as Measured by the Patient Health Questionnaire-9(Baseline, 8 weeks, 12 weeks)
- 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)