Cognitive HealthNCT05355870
Cognitive Training RCT for Older Chinese Americans
A study testing Cognitive Training Intervention in people with Cognitive Health and mHealth Application, run by Duke University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Health, mHealth Application, Experience-based Co-design
- What is being tested?
- Cognitive Training Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2024to 11 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals are excluded if they are bed-ridden
- receiving chemotherapy for malignancy
- have other life-threatening illnesses
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina (Participants Homes)
Durham, North Carolina, 27705
About this study
Official title: 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
Read the 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.
- Conditions
- Cognitive Health, mHealth Application, Experience-based Co-design, Cognitive Training, Ethnogeriatrics
- Being tested
- Cognitive Training Intervention
- Keywords
- mHealth, Cognitive Training, Pilot, Chinese Americans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Training InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as Measured by the status of study accrual
Meeting the recruitment goal of 30 eligible participants in 6 months (Yes/No)
Measured: Approximately 6 months
Feasibility as Measured by Study Adherence
The proportion of participants in the intervention arm who successfully completing all intervention sessions
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 8 weeks, 12 weeks
Secondary outcomes (5)
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
Measured: Baseline, 8 weeks, 12 weeks
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
Measured: Baseline, 8 weeks, 12 weeks
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
Measured: 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)
The WHOQOL-BREF ranges from 0 to 100, with higher scores indicated better quality of life
Measured: Baseline, 8 weeks, 12 weeks
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
Measured: Baseline, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start15 Dec 2024
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive HealthStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Hanzhang Xu, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355870
- Sponsor's protocol ID
- Pro00109934
- Other IDs
- R21AG075228
- Status last verified
- Jan 2025
- First submitted
- 21 Apr 2022
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40690756
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Cognitive Training Intervention Pilot for Older Chinese Americans
- ClinicalTrials.gov ID
- NCT05355870
- Acronym / sponsor ID
- Pro00109934
- Conditions
- Cognitive Health, mHealth Application, Experience-based Co-design, Cognitive Training, Ethnogeriatrics
- Keywords
- mHealth, Cognitive Training, Pilot, Chinese Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- New York University, National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive Training InterventionParticipants 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). |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals are excluded if they are bed-ridden
- receiving chemotherapy for malignancy
- have other life-threatening illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Training InterventionParticipants 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. | Behavioural | Cognitive Training |
Primary outcome
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)
Feasibility as Measured by Study Adherence
Time frame: 12 weeks
The proportion of participants in the intervention arm who successfully completing all intervention sessions
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
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
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
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
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
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
5 secondary outcomes
Change in Loneliness as Measured by the University of California, Los Angeles three item Loneliness Scale
Time frame: 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
Change in Depressive Symptoms as Measured by the Patient Health Questionnaire-9
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 40690756Xue 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanzhang Xu, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training Intervention in people with Cognitive Health and mHealth Application, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Measured by the status of study accrual (time frame: Approximately 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05355870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.