Clinical trial NCT05355870: Cognitive Training RCT for Older Chinese Americans
Official title: mHealth Cognitive Training Intervention Pilot for Older Chinese Americans
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cognitive Health
mHealth Application
Experience-based Co-design
Cognitive Training
Ethnogeriatrics
Keywords: mHealth
Cognitive Training
Pilot
Chinese Americans
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: New York University
name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2022-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as Measured by the status of study accrual
timeFrame: Approximately 6 months
measure: Feasibility as Measured by Study Adherence
timeFrame: 12 weeks
measure: Feasibility as Measured by Adherence to Measurement Strategies at week 8
timeFrame: 8 weeks
measure: Feasibility as Measured by Adherence to Measurement Strategies at week 12
timeFrame: 12 weeks
measure: Acceptability as Measured by the Client Satisfaction Questionnaire
timeFrame: 12 weeks
measure: Duration of cognitive training as Measured by the average time to complete a cognitive exercise
timeFrame: Over the course of the intervention, 12 weeks
measure: Days of App use as Measured by the percentage of days that participants use the app
timeFrame: Over the course of the intervention, 12 weeks
measure: Change in Global cognition as a composite measure of Mini-Mental State Examination(MMSE), Digit Span Test, verbal fluency, and the Trail Making Test
timeFrame: Baseline, 8 weeks, 12 weeks
Secondary outcomes:
measure: Change in Loneliness as Measured by the University of California, Los Angeles three item Loneliness Scale
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Change in Depressive Symptoms as Measured by the Patient Health Questionnaire-9
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Change in Quality of Life as Measured by the World Health Organization Quality of Life Instrument- Abbreviated Version (WHOQOL-BREF)
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Change in Physical Functioning as Measured by the Activities of Daily Living and Instrumental Activities of Daily Living Scale
timeFrame: Baseline, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: North Carolina (Participants Homes)
state: North Carolina
Study officials:
affiliation: Duke University
name: Hanzhang Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References: