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DREAM Project Community Health Worker Intervention

NCT ID: NCT02041598

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-01

Study Completion Date

2016-02-25

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Full CHW Intervention

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

Group Type EXPERIMENTAL

CHW Intervention

Intervention Type OTHER

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

Control: Intro to Diabetes Session Only

One-time, Introduction to Diabetes educational session only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CHW Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadia Islam, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University School of Medicine, Department of Population Health

Locations

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New York University School of Medicine, Dept of Population Health

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23749774 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36273386 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24548534 (View on PubMed)

Other Identifiers

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P60MD000538

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U48DP001904

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-0510

Identifier Type: -

Identifier Source: org_study_id