NCT02041598

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
441

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2016

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

6.7 years

First QC Date

January 16, 2014

Last Update Submit

October 16, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in Baseline Hemoglobin A1c at 6-Months

    Change in Baseline HbA1c at 6-Months

    Baseline, 6-Months

Secondary Outcomes (7)

  • Change in Baseline Perceived Social Support at 6-Months

    Baseline, 6-Months

  • Change in Baseline Perceived Benefits & Barriers at 6-Months

    Baseline, 6-Months

  • Change in Baseline Self-Efficacy at 6-Months

    Baseline, 6-Months

  • Change in Baseline Access to / Utilization of healthcare at 6-Months

    Baseline, 6-Months

  • Change in Baseline Diabetic Management Practices & Knowledge at 6-Months

    Baseline, 6-Months

  • +2 more secondary outcomes

Study Arms (2)

Full CHW Intervention

EXPERIMENTAL

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

Other: CHW Intervention

Control: Intro to Diabetes Session Only

NO INTERVENTION

One-time, Introduction to Diabetes educational session only

Interventions

CHW InterventionOTHER

5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period

Full CHW Intervention

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine, Dept of Population Health

New York, New York, 10016, United States

Location

Related Publications (3)

  • 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.

    PMID: 23749774BACKGROUND

  • 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.

    PMID: 36273386DERIVED

  • 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.

    PMID: 24548534DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nadia Islam, PhD

    New York University School of Medicine, Department of Population Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 22, 2014

Study Start

July 1, 2009

Primary Completion

February 25, 2016

Study Completion

February 25, 2016

Last Updated

October 18, 2017

Record last verified: 2017-10

Locations

US(1)