Cognitive Training RCT for Older Chinese Americans

Cognitive Training Clinical Trial

Official title:

mHealth Cognitive Training Intervention Pilot for Older Chinese Americans

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05355870
• Other study ID #: Pro00109934
• Secondary ID: R21AG075228
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 13, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Health
• Cognitive Training

Intervention

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.

Locations

Country	Name	City	State
United States	North Carolina (Participants Homes)	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	National Institute on Aging (NIA), National Institutes of Health (NIH), New York University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility as Measured by Study Adherence	The proportion of participants in the intervention arm who successfully completing all intervention sessions	12 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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