DREAM Project Community Health Worker Intervention

Study Overview
=================
Brief Summary
-----------------
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).

Detailed 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.

Official Title
-----------------
DREAM Project Community Health Worker Intervention

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: CHW Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full CHW Intervention<br>5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed | Other: CHW Intervention<br>* 5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period<br>|
| No Intervention: Control: Intro to Diabetes Session Only<br>One-time, Introduction to Diabetes educational session only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Hemoglobin A1c at 6-Months | Change in Baseline HbA1c at 6-Months | Baseline, 6-Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Perceived Social Support at 6-Months | Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint | Baseline, 6-Months | 
| Change in Baseline Perceived Benefits & Barriers at 6-Months | Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint | Baseline, 6-Months | 
| Change in Baseline Self-Efficacy at 6-Months | Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint | Baseline, 6-Months | 
| Change in Baseline Access to / Utilization of healthcare at 6-Months | Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint | Baseline, 6-Months | 
| Change in Baseline Diabetic Management Practices & Knowledge at 6-Months | Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint | Baseline, 6-Months | 
| Change in Baseline Engagement in Physical Activity & Healthy eating at 6-Months | Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint | Baseline, 6-Months | 
| Change in Baseline Lipid Profile at 6-Months | HDL, LDL, Triglycerides, Total Cholesterol | Baseline, 6-Months |