Dementia CaregiversNCT05461495
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
A study testing Treatment Group in people with Dementia Caregivers and Diabetes, run by New York University at 1 site in United States.
Trial summary
This study will conduct a two-arm randomized controlled trial to test the efficacy of a culturally tailored version of the NYU Caregiver Intervention (NYUCI) plus enhanced support (ES) through online chat groups (the NYUCI plus WeChat/Kakaotalk/other social media apps [popular social media apps for individuals of… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dementia Caregivers, Diabetes, Heart Disease
- What is being tested?
- Treatment Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A spouse or other family caregiver of Chinese or Korean ancestry living in New York City or Bergen County New Jersey, who is willing to participate in the study (additional family members can be included in family counseling sessions if the CG is assigned to the treatment group)
- at least 50 years of age
- self-identified as a primary caregiver
- have access to Internet and phone with SMS and voice messaging
- no plans to move for 12 months
- able to read English, Chinese, or Korean
Show all 9Show fewer
- capable of completing informed consent
- meet specific cardiometabolic and depressive symptom criteria: Cardiometabolic syndrome: It will not be required to submit objective measurement of cardiometabolic disorder, self-reported medical conditions will be accepted for enrollment. Diabetes: self-reported OR A1C >= 5.7% OR High Cholesterol: self-reported OR low-density lipoprotein (LDL) > 130 mg/dL or total cholesterol > 200 mg/dL (American Heart Association 2018) OR Hypertension: self-reported OR systolic blood pressure (SBP) >= 130 mmHg or diastolic blood pressure (DBP) >= 80mmHg (2017 ACC/AHA hypertension guideline) OR Body Mass Index > 23 kg/m2 by self-reported or measured height and weight (WHO expert consultation regarding Asian cut-off) OR other related metabolic syndrome, such as euthyroid hypothyroxinemia
- care recipient regularly has trouble remembering recent events, repeat the same question over and over, or lose or misplace things
Who cannot join
- current alcoholic or substance abuse; and history of psychiatric diagnoses requiring hospitalization during the past 5 years
Trial locations and contacts
1 site in 1 country.
About this study
This study will conduct a two-arm randomized controlled trial to test the efficacy of a culturally tailored version of the NYU Caregiver Intervention (NYUCI) plus enhanced support (ES) through online chat groups (the NYUCI plus WeChat/Kakaotalk/other social media apps [popular social media apps for individuals of Chinese or Korean descents] peer support which we call the NYUCI-ES in reducing health risks for cardiometabolic disease among older Chinese and Korean American adults caring for relatives with ADRD. In collaboration with community organizations across the New York and northern New Jersey metropolitan area, we will enroll 300 caregivers of people with ADRD (150 Chinese and 150 Korean) in this study. Aim 1: Develop culturally adapted informational and educational materials about dementia and caregiving issues for social service providers of the intervention and for family caregivers. Aim 2: Test the hypothesis, H1: A counseling and support intervention (the NYUCI-ES) will significantly improve psychosocial factors such as depression, stress self-rated health and chronic disease management among Chinese and Korean-American ADRD caregivers and these changes will be mediated by improvement in social support. H1a: By the first (6- month) follow-up, the mediators (increases in social support, stress reaction) will improve significantly in the intervention group compared to baseline values and the control group. H1b: These improvements will be maintained, and lead to reduction in depressive symptoms, and improvement in self-reported health and chronic disease self-management by the 12-month follow-up compared to the control group. Aim 3: Test the hypothesis, H2: the NYUCI-ES will reduce biologic risk factors, including metabolic health (glycosylated hemoglobin, BMI) and inflammation (hsCRP, lipid metabolism, etc.) within 6 months of enrollment compared to baseline and a control group; these changes will be mediated through increases in social support and decreases in depressive symptoms and will be maintained at the 12-month follow-up. The public health significance of these findings will likely have an impact on health care policy for CGs from diverse underserved ethnic and cultural backgrounds, potentially reducing morbidity, and improving their quality of life.
Read the detailed description
The physical and emotional demands of dementia caregiving can have enormous negative effects on caregivers' physical and mental health. Dementia caregivers have increased risk of hypertension and diabetes, compared to non-caregivers, especially in minority populations. The NYUCI has proven efficacy in reducing psychological outcomes among largely White samples of caregivers of persons with ADRD and has been widely replicated and translated in the USA and elsewhere. This study will provide the first large- scale test of the potential effects of the NYUCI-ES, a multicomponent intervention that includes individual and family counseling and ongoing support via support group and online chat groups and ad hoc (on demand) counseling.
Chinese American and Korean American dementia caregivers with multiple chronic conditions will be enrolled. This is an unblinded, randomized trial to assess the effectiveness of NYUCI intervention among Chinese and Korean American dementia caregivers. The study will utilize quantitative methods to learn more about the physical health and psychological health outcomes in Chinese and Korean American dementia caregivers.
This study lasts 1 year. The intervention will include two group with each ethnicity group. All participants will participate an on-line chat group and call the counselor for resource information and support as needed. Participants in the treatment group will receive 6 counseling sessions an participate in local support group.
- Conditions
- Dementia Caregivers, Diabetes, Heart Disease, Overweight
- Being tested
- Treatment Group
- Keywords
- Dementia caregivers, Social support, depressive symptoms, physical health, Chinese American, Korean American
- Medical subject headings
- Diabetes Mellitus, Heart Diseases, Overweight, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment GroupBehavioural
This intervention is unique in its emphasis on family support and in providing ongoing availability of the counselor. While the NYUCI is being implemented in several communities, its effectiveness in Chinese and Korean American dementia caregivers has not been tested. The first component of the intervention consists of two individual and four family counseling sessions that include relatives suggested by the caregiver. The second component of the intervention is participation in a support group to provide the caregiver with continuous emotional support and education. The third component of the treatment is participation in an on-line chat group to provide peer support. The fourth component of the treatment is "ad hoc" counseling the continuous availability of counselors to caregivers and families to help them deal with crises and with the changing nature and severity of their relatives' symptoms over the course of the disease.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment group will receive 6 counseling sessions, participate in local support group and on-line chat group, and receive "ad hoc" counseling. Receives: Behavioral: Treatment Group |
| Control Group | No intervention | Control group will participate in on-line chat group, and call the counselor for resource information and support as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire-9 (score range: 0-27; higher scores mean more depressive symptoms), because of its brevity, well-validated reliable measures, that has been used in other studies of Chinese and Korean adults.
Measured: 12 months
Self-rated Health
This measure includes three global self-rated physical health items from the Older Americans Resources and Services (OARS) battery of questionnaires (ICC = 0.83) to assess subjective evaluation of health. The sum of the 3 questions is used to measure self-rated health.
Measured: 12 months
Caregiving related stress
It will be measured by the severity of reaction axis of the Revised Memory and Behavior Problems Checklist.
Measured: 12 months
Positive aspects of caregiving
The 9-item Positive Aspects of Caregiving Scale will be used to measure positive aspects of caregiving, indicating that higher scores mean more positive caregiving experiences (score range: 9-45).
Measured: 12 months
Stigma
Stigma will be measured using the 12-item Affiliated Stigma Scale, with higher scores indicating greater affiliate stigma (score range: 12-84).
Measured: 12 months
Chronic disease self management behaviors
It will be measured with the Summary of Diabetes Self-Care Activities Measure, which is widely used by diabetes researchers and assesses frequency of healthy eating (e.g., how many of the last seven days did you eat five or more servings of fruits and vegetables), exercise/physical activity (5-item Simple Physical Activity Questionnaire), testing blood sugar, foot care. Sleep hours and quality, smoking, alcohol consumption, and encounters with health providers will also be measured.
Measured: 12 months
Loneliness
A 5-item scale about loneliness from the NIH Toolbox Adult Social Relationship Scales derived from UCLA Loneliness Scale will be used to measure loneliness. Scores range from 5 to 25, indicating that higher scores mean greater loneliness.
Measured: 12 months
Social support
The following measures will be used to assess various aspects of social support. Subjective social support will be measured using the Lubben Social Network Scale-6-item version. The Social Support Availability Scale will be used to evaluate the availability of emotional, instrumental, and informational support. The use of formal support services, such as respite care, support groups, and home health care aids, will be assessed with the Service Utilization Scale. Additionally, the WeChat Use Intensity Questionnaire (WUIQ) will be used to measure the use of social media applications, and it will be adapted to include KakaoTalk and other platforms.
Measured: 12 months
Diabetes
HbA1C will be measured through a fingerstick and processed in the Bayer A1CNow® device, which is National Glycohemoglobin Standardization Program Certified and has demonstrated accuracy and precision. A cut-off of HbA1C >= 5.7% will be used to determine pre-diabetic status.
Measured: 12 months
Lipid metabolism
Triglycerides, Cholesterol, HDL, LDL, and VLDL will be measured along with HbA1c using the same method. Low-density lipoprotein (LDL) > 130 mg/dL or total cholesterol > 200 mg/dL will be used to determine high cholesterol.
Measured: 12 months
Inflammation
Along with the levels of diabetes and lipid metabolism, inflammatory status will be evaluated by measuring blood levels of hsCRP, with values above 3 mg/L indicating elevated inflammation.
Measured: 12 months
Hypertension
Blood pressure will be measured utilizing PhenX Toolkit recommended procedures and OMRON automated blood pressure machine. A cut-off of systolic blood pressure (SBP) >= 130 mmHg or diastolic blood pressure (DBP) >= 80mmHg will be used to determine the presence of hypertension
Measured: 12 months
Body Mass index (BMI)
BMI will be measured through height (feet/inches or cm) and weight (lb or kg) measurements. A digital scale and stadiometer will be used to measure height and weight. Weight and height will be combined to report Body Mass Index in > 23 kg/m2 will be used to determine obesity.
Measured: 12 months
Waist circumference
Waist circumference (cm or inch) will be measured using a flexible, non-stretchable measuring tape at the halfway point between the lower margin of the last palpable rib and the top of the hip bone.
Measured: 12 months
Care recipient's cognitive impairment
The Functional Assessment Staging Tool (FAST) will be used.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Feb 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dementia CaregiversStudies of the same condition, open and under way.
- More trials run by New York 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health, Rutgers University
- Responsible party
- Sponsor
- Investigators
- Xiang Qi, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461495
- Sponsor's protocol ID
- P50MD017356-8241
- Other IDs
- P50MD017356
- Status last verified
- Jun 2026
- First submitted
- 18 May 2022
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data collected during the trial will be shared between 9 months and 36 months following article publication or as required by a condition of awards and agreements supporting the research, for researchers who provide a methodologically sound proposal. Data will be made available at https://www.icpsr.umich.edu/web/pages (Note: a specific link will be provided after the study is published/when the DOI is obtained.) The protocol, statistical analysis plan, and analytic code will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Qi X, Ko E, Ruan JY, Wang J, Leong T, Jung JH, Su J, Pei Y, Mittelman MS, Wu B. Stigma, isolation, and depression in Chinese and Korean American dementia caregivers. Alzheimers Dement (Amst). 2026 Apr 6;18(2):e70272. doi: 10.1002/dad2.70272. eCollection 2026 Apr-Jun.
PubMed 41953933Wang J, Qi X, Mittelman MS, Ko E, Pei Y, Leong IT, Park S, Wang K, Mao W, Epstein C, Wu B. Engaging Chinese and Korean American communities in dementia research: A journey of inclusivity and partnership. Alzheimers Dement. 2025 Oct;21(10):e70664. doi: 10.1002/alz.70664.
PubMed 41104647Ko E, Wu B, Wang J, Qi X, Leong IT, Pei Y, Mao W, Su J, Zhang F, Wang L, Epstein C, Mittelman MS. Exploring the Cultural Adaptation of an Ongoing Evidence-Based Intervention for Chinese and Korean American Dementia Caregivers: Descriptive Study. JMIR Form Res. 2026 Apr 23;10:e86499. doi: 10.2196/86499.
PubMed 42024866Wang J, Leong IT, Johnson MK, Pei Y, Lee KH, Mittelman MS, Epstein C, Cho S, Wu B. What Matters to Chinese and Korean American Dementia Caregivers: Navigating Cultural Influences in Dementia Care from Caregivers' Perspectives. J Alzheimers Dis. 2024;98(2):519-538. doi: 10.3233/JAD-231140.
PubMed 38427483
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
- ClinicalTrials.gov ID
- NCT05461495
- Acronym / sponsor ID
- P50MD017356-8241
- Conditions
- Dementia Caregivers, Diabetes, Heart Disease, Overweight
- Keywords
- Dementia caregivers, Social support, depressive symptoms, physical health, Chinese American, Korean American
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- NYU Langone Health, Rutgers University
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Jul 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.
This study will conduct a two-arm randomized controlled trial to test the efficacy of a culturally tailored version of the NYU Caregiver Intervention (NYUCI) plus enhanced support (ES) through online chat groups (the NYUCI plus WeChat/Kakaotalk/other social media apps [popular social media apps for individuals of Chinese or Korean descents] peer support which we call the NYUCI-ES in reducing health risks for cardiometabolic disease among older Chinese and Korean American adults caring for relatives with ADRD. In collaboration with community organizations across the New York and northern New Jersey metropolitan area, we will enroll 300 caregivers of people with ADRD (150 Chinese and 150 Korean) in this study. Aim 1: Develop culturally adapted informational and educational materials about dementia and caregiving issues for social service providers of the intervention and for family caregivers. Aim 2: Test the hypothesis, H1: A counseling and support intervention (the NYUCI-ES) will significantly improve psychosocial factors such as depression, stress self-rated health and chronic disease management among Chinese and Korean-American ADRD caregivers and these changes will be mediated by improvement in social support. H1a: By the first (6- month) follow-up, the mediators (increases in social support, stress reaction) will improve significantly in the intervention group compared to baseline values and the control group. H1b: These improvements will be maintained, and lead to reduction in depressive symptoms, and improvement in self-reported health and chronic disease self-management by the 12-month follow-up compared to the control group. Aim 3: Test the hypothesis, H2: the NYUCI-ES will reduce biologic risk factors, including metabolic health (glycosylated hemoglobin, BMI) and inflammation (hsCRP, lipid metabolism, etc.) within 6 months of enrollment compared to baseline and a control group; these changes will be mediated through increases in social support and decreases in depressive symptoms and will be maintained at the 12-month follow-up. The public health significance of these findings will likely have an impact on health care policy for CGs from diverse underserved ethnic and cultural backgrounds, potentially reducing morbidity, and improving their quality of life.
Detailed description
The physical and emotional demands of dementia caregiving can have enormous negative effects on caregivers' physical and mental health. Dementia caregivers have increased risk of hypertension and diabetes, compared to non-caregivers, especially in minority populations. The NYUCI has proven efficacy in reducing psychological outcomes among largely White samples of caregivers of persons with ADRD and has been widely replicated and translated in the USA and elsewhere. This study will provide the first large- scale test of the potential effects of the NYUCI-ES, a multicomponent intervention that includes individual and family counseling and ongoing support via support group and online chat groups and ad hoc (on demand) counseling.
Chinese American and Korean American dementia caregivers with multiple chronic conditions will be enrolled. This is an unblinded, randomized trial to assess the effectiveness of NYUCI intervention among Chinese and Korean American dementia caregivers. The study will utilize quantitative methods to learn more about the physical health and psychological health outcomes in Chinese and Korean American dementia caregivers.
This study lasts 1 year. The intervention will include two group with each ethnicity group. All participants will participate an on-line chat group and call the counselor for resource information and support as needed. Participants in the treatment group will receive 6 counseling sessions an participate in local support group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Treatment GroupTreatment group will receive 6 counseling sessions, participate in local support group and on-line chat group, and receive "ad hoc" counseling. |
| Control Group | No intervention | –Control group will participate in on-line chat group, and call the counselor for resource information and support as needed. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A spouse or other family caregiver of Chinese or Korean ancestry living in New York City or Bergen County New Jersey, who is willing to participate in the study (additional family members can be included in family counseling sessions if the CG is assigned to the treatment group)
- at least 50 years of age
- self-identified as a primary caregiver
- have access to Internet and phone with SMS and voice messaging
- no plans to move for 12 months
Key exclusion criteria (1 listed)
- current alcoholic or substance abuse; and history of psychiatric diagnoses requiring hospitalization during the past 5 years
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 |
|---|---|---|
| Treatment GroupThis intervention is unique in its emphasis on family support and in providing ongoing availability of the counselor. While the NYUCI is being implemented in several communities, its effectiveness in Chinese and Korean American dementia caregivers has not been tested. The first component of the intervention consists of two individual and four family counseling sessions that include relatives suggested by the caregiver. The second component of the intervention is participation in a support group to provide the caregiver with continuous emotional support and education. The third component of the treatment is participation in an on-line chat group to provide peer support. The fourth component of the treatment is "ad hoc" counseling the continuous availability of counselors to caregivers and families to help them deal with crises and with the changing nature and severity of their relatives' symptoms over the course of the disease. | Behavioural | Treatment Group |
Primary outcome
Depressive symptoms
Time frame: 12 months
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire-9 (score range: 0-27; higher scores mean more depressive symptoms), because of its brevity, well-validated reliable measures, that has been used in other studies of Chinese and Korean adults.
Self-rated Health
Time frame: 12 months
This measure includes three global self-rated physical health items from the Older Americans Resources and Services (OARS) battery of questionnaires (ICC = 0.83) to assess subjective evaluation of health. The sum of the 3 questions is used to measure self-rated health.
Caregiving related stress
Time frame: 12 months
It will be measured by the severity of reaction axis of the Revised Memory and Behavior Problems Checklist.
Positive aspects of caregiving
Time frame: 12 months
The 9-item Positive Aspects of Caregiving Scale will be used to measure positive aspects of caregiving, indicating that higher scores mean more positive caregiving experiences (score range: 9-45).
Stigma
Time frame: 12 months
Stigma will be measured using the 12-item Affiliated Stigma Scale, with higher scores indicating greater affiliate stigma (score range: 12-84).
Chronic disease self management behaviors
Time frame: 12 months
It will be measured with the Summary of Diabetes Self-Care Activities Measure, which is widely used by diabetes researchers and assesses frequency of healthy eating (e.g., how many of the last seven days did you eat five or more servings of fruits and vegetables), exercise/physical activity (5-item Simple Physical Activity Questionnaire), testing blood sugar, foot care. Sleep hours and quality, smoking, alcohol consumption, and encounters with health providers will also be measured.
Loneliness
Time frame: 12 months
A 5-item scale about loneliness from the NIH Toolbox Adult Social Relationship Scales derived from UCLA Loneliness Scale will be used to measure loneliness. Scores range from 5 to 25, indicating that higher scores mean greater loneliness.
Social support
Time frame: 12 months
The following measures will be used to assess various aspects of social support. Subjective social support will be measured using the Lubben Social Network Scale-6-item version. The Social Support Availability Scale will be used to evaluate the availability of emotional, instrumental, and informational support. The use of formal support services, such as respite care, support groups, and home health care aids, will be assessed with the Service Utilization Scale. Additionally, the WeChat Use Intensity Questionnaire (WUIQ) will be used to measure the use of social media applications, and it will be adapted to include KakaoTalk and other platforms.
Diabetes
Time frame: 12 months
HbA1C will be measured through a fingerstick and processed in the Bayer A1CNow® device, which is National Glycohemoglobin Standardization Program Certified and has demonstrated accuracy and precision. A cut-off of HbA1C >= 5.7% will be used to determine pre-diabetic status.
Lipid metabolism
Time frame: 12 months
Triglycerides, Cholesterol, HDL, LDL, and VLDL will be measured along with HbA1c using the same method. Low-density lipoprotein (LDL) > 130 mg/dL or total cholesterol > 200 mg/dL will be used to determine high cholesterol.
Inflammation
Time frame: 12 months
Along with the levels of diabetes and lipid metabolism, inflammatory status will be evaluated by measuring blood levels of hsCRP, with values above 3 mg/L indicating elevated inflammation.
Hypertension
Time frame: 12 months
Blood pressure will be measured utilizing PhenX Toolkit recommended procedures and OMRON automated blood pressure machine. A cut-off of systolic blood pressure (SBP) >= 130 mmHg or diastolic blood pressure (DBP) >= 80mmHg will be used to determine the presence of hypertension
Body Mass index (BMI)
Time frame: 12 months
BMI will be measured through height (feet/inches or cm) and weight (lb or kg) measurements. A digital scale and stadiometer will be used to measure height and weight. Weight and height will be combined to report Body Mass Index in > 23 kg/m2 will be used to determine obesity.
Waist circumference
Time frame: 12 months
Waist circumference (cm or inch) will be measured using a flexible, non-stretchable measuring tape at the halfway point between the lower margin of the last palpable rib and the top of the hip bone.
Care recipient's cognitive impairment
Time frame: 12 months
The Functional Assessment Staging Tool (FAST) will be used.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 41953933Qi X, Ko E, Ruan JY, Wang J, Leong T, Jung JH, Su J, Pei Y, Mittelman MS, Wu B. Stigma, isolation, and depression in Chinese and Korean American dementia caregivers. Alzheimers Dement (Amst). 2026 Apr 6;18(2):e70272. doi: 10.1002/dad2.70272. eCollection 2026 Apr-Jun.
- Background: PubMed 41104647Wang J, Qi X, Mittelman MS, Ko E, Pei Y, Leong IT, Park S, Wang K, Mao W, Epstein C, Wu B. Engaging Chinese and Korean American communities in dementia research: A journey of inclusivity and partnership. Alzheimers Dement. 2025 Oct;21(10):e70664. doi: 10.1002/alz.70664.
- Background: PubMed 42024866Ko E, Wu B, Wang J, Qi X, Leong IT, Pei Y, Mao W, Su J, Zhang F, Wang L, Epstein C, Mittelman MS. Exploring the Cultural Adaptation of an Ongoing Evidence-Based Intervention for Chinese and Korean American Dementia Caregivers: Descriptive Study. JMIR Form Res. 2026 Apr 23;10:e86499. doi: 10.2196/86499.
- Background: PubMed 38427483Wang J, Leong IT, Johnson MK, Pei Y, Lee KH, Mittelman MS, Epstein C, Cho S, Wu B. What Matters to Chinese and Korean American Dementia Caregivers: Navigating Cultural Influences in Dementia Care from Caregivers' Perspectives. J Alzheimers Dis. 2024;98(2):519-538. doi: 10.3233/JAD-231140.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data collected during the trial will be shared between 9 months and 36 months following article publication or as required by a condition of awards and agreements supporting the research, for researchers who provide a methodologically sound proposal. Data will be made available at https://www.icpsr.umich.edu/web/pages (Note: a specific link will be provided after the study is published/when the DOI is obtained.) The protocol, statistical analysis plan, and analytic code will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Xiang Qi, PhD principal investigator
New York 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 Treatment Group in people with Dementia Caregivers and Diabetes, run by New York 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 9 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Depressive symptoms (time frame: 12 months). The study lists 15 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 NCT05461495, which also lists 4 linked publications.
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 6 Nov 2026.