Skip to main content
OpenTrials
Completed

NCT Number: NCT05355870

Cognitive Training RCT 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Carolina (Participants Homes)

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. Feasibility as Measured by Study Adherence

    Time frame: 12 weeks

    The proportion of participants in the intervention arm who successfully completing all intervention sessions

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Official study title

mHealth Cognitive Training Intervention Pilot for Older Chinese Americans

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 2, 2022
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.