Clinical trial NCT02041598: DREAM Project Community Health Worker Intervention
Official title: DREAM Project Community Health Worker Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2014-01-22
Enrollment: 441
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in Baseline Hemoglobin A1c at 6-Months
timeFrame: Baseline, 6-Months
Secondary outcomes:
measure: Change in Baseline Perceived Social Support at 6-Months
timeFrame: Baseline, 6-Months
measure: Change in Baseline Perceived Benefits & Barriers at 6-Months
timeFrame: Baseline, 6-Months
measure: Change in Baseline Self-Efficacy at 6-Months
timeFrame: Baseline, 6-Months
measure: Change in Baseline Access to / Utilization of healthcare at 6-Months
timeFrame: Baseline, 6-Months
measure: Change in Baseline Diabetic Management Practices & Knowledge at 6-Months
timeFrame: Baseline, 6-Months
measure: Change in Baseline Engagement in Physical Activity & Healthy eating at 6-Months
timeFrame: Baseline, 6-Months
measure: Change in Baseline Lipid Profile at 6-Months
timeFrame: Baseline, 6-Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine, Dept of Population Health
state: New York
Study officials:
affiliation: New York University School of Medicine, Department of Population Health
name: Nadia Islam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Islam NS, Wyatt LC, Patel SD, Shapiro E, Tandon SD, Mukherji BR, Tanner M, Rey MJ, Trinh-Shevrin C. Evaluation of a community health worker pilot intervention to improve diabetes management in Bangladeshi immigrants with type 2 diabetes in New York City. Diabetes Educ. 2013 Jul-Aug;39(4):478-93. doi: 10.1177/0145721713491438. Epub 2013 Jun 7.
citation: Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.
citation: Islam N, Riley L, Wyatt L, Tandon SD, Tanner M, Mukherji-Ratnam R, Rey M, Trinh-Shevrin C. Protocol for the DREAM Project (Diabetes Research, Education, and Action for Minorities): a randomized trial of a community health worker intervention to improve diabetic management and control among Bangladeshi adults in NYC. BMC Public Health. 2014 Feb 18;14:177. doi: 10.1186/1471-2458-14-177.