DREAM Project Community Health Worker Intervention

NYU Langone Health

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: CHW Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02041598

P60MD000538 (U.S. NIH Grant/Contract)

09-0510

U48DP001904 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC).

Full description

The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC). For a two-arm, randomized controlled trial (RCT), investigators will recruit a sample of 256 participants, all of whom are 1) of Bangladeshi descent, 2) residing in NYC, 3) diagnosed with Type 2 diabetes mellitus (T2DM) and a recent Hemoglobin A1c (HbA1c) of ≥ 6.5, and 4) between the ages of 21-85. The treatment group receives a six-month CHW-led intervention consisting of five monthly group educational sessions, two one-on-one visits, and follow-up phone calls as needed from a CHW. The control group receives an introductory educational session only. Primary and secondary outcomes include clinical and behavioral measures, such as HbA1c and weight change, access to and utilization of care (i.e. appointment keeping and use of specialty care), and knowledge and practice of physical activity and healthful eating. Additionally, information regarding CHW characteristics, the processes and mechanisms for influencing healthful behavior change, and fidelity of the intervention are collected. Outcomes are measured at Baseline, 3-Months, 6-Months for both groups, and at 12-Months for the treatment group.

Enrollment: 441 patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed clinical diagnosis of T2DM with a Hemoglobin A1c (HbA1c) of ≥ 6.5%; and
• male or female between the ages of 21-85 years old; and
• willingness to be randomized to either treatment or control groups.

Exclusion criteria

• is or was on renal dialysis;
• experiencing an acute or terminal illness or serious mental illness;
• had a history of recent coronary event within the last 3 months of recruitment;
• is pregnant at the time of recruitment;
• experienced other severe medical conditions that might preclude participation;
• has poor short-term prognosis (expected death in <2 years); or
• is participating in another research study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

441 participants in 2 patient groups

Full CHW Intervention

Experimental group

Description:

5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed

Treatment:

Other: CHW Intervention

Control: Intro to Diabetes Session Only

No Intervention group

Description:

One-time, Introduction to Diabetes educational session only