Cognitive Training RCT for Older Chinese Americans

Study Overview
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Brief Summary
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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
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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.

Official Title
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mHealth Cognitive Training Intervention Pilot for Older Chinese Americans

Conditions
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Cognitive Health, mHealth Application, Experience-based Co-design, Cognitive Training, Ethnogeriatrics

Intervention / Treatment
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* Behavioral: Cognitive Training Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Training<br>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). | Behavioral: Cognitive Training Intervention<br>* Participants in the intervention group will complete a series of cognitive training exercises adapted from the BrainHQ. Results from the intervention development activities will be used to finalize the dose, frequency, and duration of the training. Each session will include 2 training exercises that target different cognitive domains. As participants progress, the difficulty level will be automatically adapted based on participants' performance.<br>|
| No Intervention: Passive Control<br>A passive control group will be included in this pilot trial. Participants in this passive control 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as Measured by the status of study accrual | Meeting the recruitment goal of 30 eligible participants in 6 months (Yes/No) | Approximately 6 months | 
| Feasibility as Measured by Study Adherence | The proportion of participants in the intervention arm who successfully completing all intervention sessions | 12 weeks | 
| Feasibility as Measured by Adherence to Measurement Strategies at week 8 | The proportion of participants completing the 8-week assessments in both arms | 8 weeks | 
| Feasibility as Measured by Adherence to Measurement Strategies at week 12 | The proportion of participants completing the 12-week assessments in both arms | 12 weeks | 
| Acceptability as Measured by the Client Satisfaction Questionnaire | The Client Satisfaction Questionnaire (CSQ) ranges from 8 to 32, with scores over the 80% suggested adequate acceptability | 12 weeks | 
| Duration of cognitive training as Measured by the average time to complete a cognitive exercise | 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 | Over the course of the intervention, 12 weeks | 
| Days of App use as Measured by the percentage of days that participants use the app | 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 | Over the course of the intervention, 12 weeks | 
| Change in Global cognition as a composite measure of Mini-Mental State Examination(MMSE), Digit Span Test, verbal fluency, and the Trail Making Test | 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 | Baseline, 8 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Loneliness as Measured by the University of California, Los Angeles three item Loneliness Scale | The University of California, Los Angeles (UCLA) Loneliness Scale ranges from 3 to 9, with higher scores indicated greater degrees of loneliness | Baseline, 8 weeks, 12 weeks | 
| Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale | The HADS - Anxiety Scale ranges from 0 to 21, with higher scores indicated greater degrees of anxiety | Baseline, 8 weeks, 12 weeks | 
| Change in Depressive Symptoms as Measured by the Patient Health Questionnaire-9 | PHQ-9 ranges from 0 to 27, with higher scores indicated greater depressive symptoms | 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) | The WHOQOL-BREF ranges from 0 to 100, with higher scores indicated better quality of life | Baseline, 8 weeks, 12 weeks | 
| Change in Physical Functioning as Measured by the Activities of Daily Living and Instrumental Activities of Daily Living Scale | Score ranges from 14 to 52, with higher scores indicated higher degree of physical functioning | Baseline, 8 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Cognitive Training, Pilot, Chinese Americans