NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
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ClinicalTrials.gov Identifier: NCT05461495 |
Recruitment Status :
Recruiting
First Posted : July 18, 2022
Last Update Posted : November 8, 2023
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Condition or disease | Intervention/treatment | Phase |
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Dementia Caregivers Diabetes Heart Disease Overweight | Behavioral: Treatment Group | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers |
Actual Study Start Date : | February 1, 2023 |
Estimated Primary Completion Date : | June 30, 2026 |
Estimated Study Completion Date : | June 30, 2026 |
Arm | Intervention/treatment |
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Experimental: Treatment Group
Treatment group will receive 6 counseling sessions, participate in local support group and on-line chat group, and receive "ad hoc' counseling.
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Behavioral: Treatment Group
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. |
No Intervention: Control Group
Control group will participate in on-line chat group, and call the counselor for resource information and support as needed.
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- Depressive symptoms [ Time Frame: 12 months ]Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire-9 (PHQ-9),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 OARS battery of questionnaires (ICC = 0.83) to assess subjective evaluation of health. The sum of the 3 questions is used to measure SRH
- 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.
- Chronic disease self management behaviors [ Time Frame: 12 months ]It will be measured with the Summary of Diabetes Self-Care Activities Measure,98 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, testing blood sugar, foot care, and smoking.
- 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.
- 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
- BMI [ Time Frame: 12 months ]Body Mass Index (BMI) will be measured through height and weight measurements. A digital scale and stadiometer will be used to measure height and weight and calculate BMI. Body Mass Index > 23 kg/m2 will be used to determine obesity.
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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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).
Exclusion Criteria:
- current alcoholic or substance abuse; and history of psychiatric diagnoses requiring hospitalization during the past 5 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05461495
Contact: Yaolin Pei, PhD | 212 992 5964 | yp22@nyu.edu | |
Contact: Xiang Qi | 212-263-7560 | xq450@nyu.edu |
United States, New York | |
New York University | Recruiting |
New York, New York, United States, 10010 |
Principal Investigator: | Bei Wu, PhD | New York University |
Responsible Party: | New York University |
ClinicalTrials.gov Identifier: | NCT05461495 |
Other Study ID Numbers: |
P50MD017356-8241 P50MD017356 ( U.S. NIH Grant/Contract ) |
First Posted: | July 18, 2022 Key Record Dates |
Last Update Posted: | November 8, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Analytic Code |
Time Frame: | Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. |
Access Criteria: | Data will be made available at Clinicaltrials.gov and ICPSR (a specific link will be provided after the study is published/when the DOI is obtained). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dementia caregivers Social support depressive symptoms |
physical health Chinese American Korean American |
Dementia Heart Diseases Overweight Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Neurocognitive Disorders Mental Disorders Cardiovascular Diseases Overnutrition Nutrition Disorders Body Weight |