Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatment chw intervention
Sponsor New York University School of Medicine
Collaborator National Institute on Minority Health and Health Disparities (NIMHD)
Start date July 2009
End date January 2017
Trial size 240 participants
Trial identifier NCT02041598, P60MD000538, U48DP001904, i09-0510

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed
chw intervention
5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period
(No Intervention)
One-time, Introduction to Diabetes educational session only

Primary Outcomes

Measure
Change in Baseline Hemoglobin A1c at 6-Months
time frame: Baseline, 6-Months

Secondary Outcomes

Measure
Change in Baseline Perceived Social Support at 6-Months
time frame: Baseline, 6-Months
Change in Baseline Perceived Benefits & Barriers at 6-Months
time frame: Baseline, 6-Months
Change in Baseline Self-Efficacy at 6-Months
time frame: Baseline, 6-Months
Change in Baseline Access to / Utilization of healthcare at 6-Months
time frame: Baseline, 6-Months
Change in Baseline Diabetic Management Practices & Knowledge at 6-Months
time frame: Baseline, 6-Months
Change in Baseline Engagement in Physical Activity & Healthy eating at 6-Months
time frame: Baseline, 6-Months
Change in Baseline Lipid Profile at 6-Months
time frame: Baseline, 6-Months

Eligibility Criteria

Male or female participants from 25 years up to 85 years old.

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.

Additional Information

Official title DREAM Project Community Health Worker Intervention
Principal investigator Nadia Islam, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.