Diabetes Management Intervention For South Asians

Diabetes Clinical Trial

Official title:

Diabetes Management Intervention For South Asians

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03333044
• Other study ID #: 17-01479
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 11, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 859
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• HbA1c

Intervention

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
• 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.
• Physician enabled care coordination
Forms on patient goal setting and referrals made are uploaded into EHR to physician

Locations

Country	Name	City	State
United States	One Park Avenue	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients that experience a reduction in HbA1c of >0.5%	complete lipoprotein panel compared at baseline and 6 months	6 Months
Secondary	Average reduction in hemoglobin A1c test (HbA1c)	complete blood panel compared at baseline and 6 months	6 Months
Secondary	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
Secondary	Average reduction HDL (High density lipoprotein cholesterol)	complete lipoprotein panel compared at baseline and 6 months	6 Months
Secondary	Average reduction LDL (Low density lipoprotein cholesterol)	complete lipoprotein panel compared at baseline and 6 months	6 Months
Secondary	Referral to community services	Number of referrals given to community service over the course of 6 months	6 Months