Back to resultsDiabetes Management Intervention For South Asians
Primary Purpose
HbA1c, Diabetes
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Health Worker (CHW)-led health
HIT-enabled
Physician enabled care coordination
Sponsored by
About this trial
This is an interventional supportive care trial for HbA1c
Eligibility Criteria
Inclusion Criteria:
- South Asian ethnicity (identified through a race and language code available in the EHR);
- an appointment with a physician for routine non-emergent primary care in the last 12 months
- a diagnosis of diabetes for at least 12 months
- an HbA1c reading of >7 in the last 30 days
Exclusion Criteria:
- Pregnant women and visits to obstetrician/gynecologist are excluded from the study
Sites / Locations
- One Park Avenue
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
CHW-led health coaching
HIT-enabled & CHW led
CHW & Physician Feedback
Arm Description
Group sessions
Supportive care enabled by mobile devices.
Patient setting progress communicated to physician via PHI
Outcomes
Primary Outcome Measures
Percent of patients that experience a reduction in HbA1c of >0.5%
complete lipoprotein panel compared at baseline and 6 months
Secondary Outcome Measures
Average reduction in hemoglobin A1c test (HbA1c)
complete blood panel compared at baseline and 6 months
Average reduction in BMI (Body Mass Index)
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Average reduction HDL (High density lipoprotein cholesterol)
complete lipoprotein panel compared at baseline and 6 months
Average reduction LDL (Low density lipoprotein cholesterol)
complete lipoprotein panel compared at baseline and 6 months
Referral to community services
Number of referrals given to community service over the course of 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03333044
Brief Title
Diabetes Management Intervention For South Asians
Official Title
Diabetes Management Intervention For South Asians
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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
The goal of this study is to evaluate the effectiveness and implementation process of a multi-level, integrated intervention to decrease HbA1c among South Asians with uncontrolled diabetes, including four components: 1) an EHR-based registry function to increase identification of South Asian patients with uncontrolled diabetes; 2) CHW-led health coaching of registered patients to promote health behavior change; 3) HIT-enabled and CHW-facilitated identification and referral to culturally relevant community resources for patients; and 4) HIT-enabled care coordination between the CHW and other members of the healthcare team.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HbA1c, Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
859 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHW-led health coaching
Arm Type
Experimental
Arm Description
Group sessions
Arm Title
HIT-enabled & CHW led
Arm Type
Experimental
Arm Description
Supportive care enabled by mobile devices.
Arm Title
CHW & Physician Feedback
Arm Type
Experimental
Arm Description
Patient setting progress communicated to physician via PHI
Intervention Type
Behavioral
Intervention Name(s)
Community Health Worker (CHW)-led health
Intervention Description
Patients contacted a maximum of 10 times over 2 weeks to attend diabetes management sessions led by community health workers. Enrolled patients attend 5 Monthly group sessions led by a CHW held at the clinic
Intervention Type
Behavioral
Intervention Name(s)
HIT-enabled
Intervention Description
During one on one visit, CHWs will assess social needs of patients using mobile technology. CHWs will give referral sources to patients generated by mobile app, and they will track through mobile app.
Intervention Type
Behavioral
Intervention Name(s)
Physician enabled care coordination
Intervention Description
Forms on patient goal setting and referrals made are uploaded into EHR to physician
Primary Outcome Measure Information:
Title
Percent of patients that experience a reduction in HbA1c of >0.5%
Description
complete lipoprotein panel compared at baseline and 6 months
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Average reduction in hemoglobin A1c test (HbA1c)
Description
complete blood panel compared at baseline and 6 months
Time Frame
6 Months
Title
Average reduction in BMI (Body Mass Index)
Description
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Time Frame
6 Months
Title
Average reduction HDL (High density lipoprotein cholesterol)
Description
complete lipoprotein panel compared at baseline and 6 months
Time Frame
6 Months
Title
Average reduction LDL (Low density lipoprotein cholesterol)
Description
complete lipoprotein panel compared at baseline and 6 months
Time Frame
6 Months
Title
Referral to community services
Description
Number of referrals given to community service over the course of 6 months
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
South Asian ethnicity (identified through a race and language code available in the EHR);
an appointment with a physician for routine non-emergent primary care in the last 12 months
a diagnosis of diabetes for at least 12 months
an HbA1c reading of >7 in the last 30 days
Exclusion Criteria:
Pregnant women and visits to obstetrician/gynecologist are excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Islam, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
One Park Avenue
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
AFTER FINAL DATA COLLECTION AND FOLLOWING PUBLICATION OF MAIN FINDINGS MANUSCRIPT
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal. Requests should be directed to Shinu.Mammen@nyulangone.org To gain access, data requestors will need to sign a data access agreement.
Citations:
PubMed Identifier
34814899
Citation
Lim S, Wyatt LC, Mammen S, Zanowiak JM, Mohaimin S, Troxel AB, Lindau ST, Gold HT, Shelley D, Trinh-Shevrin C, Islam NS. Implementation of a multi-level community-clinical linkage intervention to improve glycemic control among south Asian patients with uncontrolled diabetes: study protocol of the DREAM initiative. BMC Endocr Disord. 2021 Nov 23;21(1):233. doi: 10.1186/s12902-021-00885-5.
Results Reference
derived
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Diabetes Management Intervention For South Asians
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