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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG075228 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| New York University | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Training | Experimental | 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). |
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| Passive Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Training Intervention | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanzhang Xu, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina (Participants Homes) | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40690756 | Derived | Xue T, Wei AA, Wu B, Sanders C, McConnell ES, Xu H. Co-Designed Mobile-Based Cognitive Training for Older Chinese Americans: Protocol for a Pilot Randomized Controlled Trial Assessing Feasibility and Acceptability. JMIR Res Protoc. 2025 Jul 21;14:e69303. doi: 10.2196/69303. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2025 | Jul 22, 2025 | ICF_000.pdf |
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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 |
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 |