DREAM Project Community Health Worker Intervention
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: CHW Intervention
- Registration Number
- NCT02041598
- Lead Sponsor
- NYU Langone Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 441
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Full CHW Intervention CHW Intervention 5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed
- Primary Outcome Measures
Name Time Method Change in Baseline Hemoglobin A1c at 6-Months Baseline, 6-Months Change in Baseline HbA1c at 6-Months
- Secondary Outcome Measures
Name Time Method Change in Baseline Access to / Utilization of healthcare at 6-Months Baseline, 6-Months Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Change in Baseline Perceived Social Support at 6-Months Baseline, 6-Months Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Change in Baseline Perceived Benefits & Barriers at 6-Months Baseline, 6-Months Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Change in Baseline Self-Efficacy at 6-Months Baseline, 6-Months Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Change in Baseline Diabetic Management Practices & Knowledge at 6-Months Baseline, 6-Months Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Change in Baseline Engagement in Physical Activity & Healthy eating at 6-Months Baseline, 6-Months Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Change in Baseline Lipid Profile at 6-Months Baseline, 6-Months HDL, LDL, Triglycerides, Total Cholesterol
Trial Locations
- Locations (1)
New York University School of Medicine, Dept of Population Health
🇺🇸New York, New York, United States