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NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers

Primary Purpose

Dementia Caregivers, Diabetes, Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment Group
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia Caregivers focused on measuring Dementia caregivers, Social support, depressive symptoms, physical health, Chinese American, Korean American

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

Treatment group will receive 6 counseling sessions, participate in local support group and on-line chat group, and receive "ad hoc' counseling.

Control group will participate in on-line chat group, and call the counselor for resource information and support as needed.

Outcomes

Primary Outcome Measures

Depressive symptoms
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
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
It will be measured by the severity of reaction axis of the Revised Memory and Behavior Problems Checklist.
Chronic disease self management behaviors
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
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
May 18, 2022
Last Updated
February 23, 2023
Sponsor
New York University
Collaborators
NYU Langone Health, Rutgers University
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1. Study Identification

Unique Protocol Identification Number
NCT05461495
Brief Title
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Official Title
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
NYU Langone Health, Rutgers University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 [population social media app for Chinese/Korean] 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) and inflammation (Oxidative stress, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Caregivers, Diabetes, Heart Disease, Overweight
Keywords
Dementia caregivers, Social support, depressive symptoms, physical health, Chinese American, Korean American

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Treatment group will receive 6 counseling sessions, participate in local support group and on-line chat group, and receive "ad hoc' counseling.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group will participate in on-line chat group, and call the counselor for resource information and support as needed.
Intervention Type
Behavioral
Intervention Name(s)
Treatment Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
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.
Time Frame
12 months
Title
Self-rated Health
Description
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
Time Frame
12 months
Title
Caregiving related stress
Description
It will be measured by the severity of reaction axis of the Revised Memory and Behavior Problems Checklist.
Time Frame
12 months
Title
Chronic disease self management behaviors
Description
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.
Time Frame
12 months
Title
Diabetes
Description
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.
Time Frame
12 months
Title
Hypertension
Description
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
Time Frame
12 months
Title
BMI
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaolin Pei, PhD
Phone
212 992 5964
Email
yp22@nyu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Qi
Phone
212-263-7560
Email
xq450@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bei Wu, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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).

Learn more about this trial

NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers

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