Cognitive Training RCT for Older Chinese Americans

NCT05355870 | Completed

• 2 other identifiers: Pro00109934R21AG075228
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Health; mHealth Application; Experience-based Co-design; Cognitive Training; Ethnogeriatrics

Keywords

mHealth; Cognitive Training; Pilot; Chinese Americans

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• Change in Loneliness as Measured by the University of California, Los Angeles three item Loneliness Scale

  Baseline, 8 weeks, 12 weeks

• Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale

  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

• Change in Physical Functioning as Measured by the Activities of Daily Living and Instrumental Activities of Daily Living Scale

  Baseline, 8 weeks, 12 weeks

Study Arms (2)

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).

Behavioral: Cognitive Training Intervention

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.

Interventions

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.

Cognitive Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals are excluded if they are bed-ridden
• receiving chemotherapy for malignancy
• have other life-threatening illnesses

Sponsors & Collaborators

• Duke University: lead
• New York University: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

North Carolina (Participants Homes)

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 40690756 DERIVED

Study Officials

• Hanzhang Xu, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 2, 2022
• Study Start: December 15, 2024
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)