Diabetes Management Intervention For South Asians

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes; HbA1c
• Intervention / Treatment: Behavioral: Community Health Worker (CHW)-led health; Behavioral: HIT-enabled; Behavioral: Physician enabled care coordination

• Study Type: Interventional
• Enrollment (Actual): 859
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • One Park Avenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHW-led health coaching; Group sessions	Behavioral: Community Health Worker (CHW)-led health; 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
Experimental: HIT-enabled & CHW led; Supportive care enabled by mobile devices.	Behavioral: HIT-enabled; 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.
Experimental: CHW & Physician Feedback; Patient setting progress communicated to physician via PHI	Behavioral: Community Health Worker (CHW)-led health; 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; Behavioral: Physician enabled care coordination; Forms on patient goal setting and referrals made are uploaded into EHR to physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of patients that experience a reduction in HbA1c of >0.5%	complete lipoprotein panel compared at baseline and 6 months	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average reduction in hemoglobin A1c test (HbA1c)	complete blood panel compared at baseline and 6 months	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.	6 Months
Average reduction HDL (High density lipoprotein cholesterol)	complete lipoprotein panel compared at baseline and 6 months	6 Months
Average reduction LDL (Low density lipoprotein cholesterol)	complete lipoprotein panel compared at baseline and 6 months	6 Months
Referral to community services	Number of referrals given to community service over the course of 6 months	6 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Nadia Islam, PhD, NYU Langone Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 17-01479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No