Cognitive Training RCT for Older Chinese Americans

November 14, 2025 updated by: Duke University

mHealth Cognitive Training Intervention Pilot for Older Chinese Americans

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • North Carolina (Participants Homes)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Training

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
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.
No Intervention: Passive Control
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Approximately 6 months
Feasibility as Measured by Study Adherence
Time Frame: 12 weeks
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
Time Frame: 8 weeks
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
Time Frame: 12 weeks
The proportion of participants completing the 12-week assessments in both arms
12 weeks
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
12 weeks
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
Over the course of the intervention, 12 weeks
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
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
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
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
Time Frame: 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
Baseline, 8 weeks, 12 weeks
Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale
Time Frame: 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
Time Frame: Baseline, 8 weeks, 12 weeks
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)
Time Frame: Baseline, 8 weeks, 12 weeks
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
Time Frame: Baseline, 8 weeks, 12 weeks
Score ranges from 14 to 52, with higher scores indicated higher degree of physical functioning
Baseline, 8 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

New York University
National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Hanzhang Xu, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2024

Primary Completion (Actual)

November 11, 2025

Study Completion (Actual)

November 11, 2025

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Estimated)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00109934
  • R21AG075228 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Training

Clinical Trials on Cognitive Training Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe