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DREAM Project Community Health Worker Intervention

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHW Intervention
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine, Dept of Population Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Full CHW Intervention

Control: Intro to Diabetes Session Only

Arm Description

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

One-time, Introduction to Diabetes educational session only

Outcomes

Primary Outcome Measures

Change in Baseline Hemoglobin A1c at 6-Months
Change in Baseline HbA1c at 6-Months

Secondary Outcome Measures

Change in Baseline Perceived Social Support at 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
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Change in Baseline Self-Efficacy at 6-Months
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Change in Baseline Access to / Utilization of healthcare at 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
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
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Change in Baseline Lipid Profile at 6-Months
HDL, LDL, Triglycerides, Total Cholesterol

Full Information

First Posted
January 16, 2014
Last Updated
October 16, 2017
Sponsor
NYU Langone Health
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02041598
Brief Title
DREAM Project Community Health Worker Intervention
Official Title
DREAM Project Community Health Worker Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2009 (Actual)
Primary Completion Date
February 25, 2016 (Actual)
Study Completion Date
February 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full CHW Intervention
Arm Type
Experimental
Arm Description
5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed
Arm Title
Control: Intro to Diabetes Session Only
Arm Type
No Intervention
Arm Description
One-time, Introduction to Diabetes educational session only
Intervention Type
Other
Intervention Name(s)
CHW Intervention
Intervention Description
5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period
Primary Outcome Measure Information:
Title
Change in Baseline Hemoglobin A1c at 6-Months
Description
Change in Baseline HbA1c at 6-Months
Time Frame
Baseline, 6-Months
Secondary Outcome Measure Information:
Title
Change in Baseline Perceived Social Support at 6-Months
Description
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Time Frame
Baseline, 6-Months
Title
Change in Baseline Perceived Benefits & Barriers at 6-Months
Description
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Time Frame
Baseline, 6-Months
Title
Change in Baseline Self-Efficacy at 6-Months
Description
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Time Frame
Baseline, 6-Months
Title
Change in Baseline Access to / Utilization of healthcare at 6-Months
Description
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Time Frame
Baseline, 6-Months
Title
Change in Baseline Diabetic Management Practices & Knowledge at 6-Months
Description
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Time Frame
Baseline, 6-Months
Title
Change in Baseline Engagement in Physical Activity & Healthy eating at 6-Months
Description
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Time Frame
Baseline, 6-Months
Title
Change in Baseline Lipid Profile at 6-Months
Description
HDL, LDL, Triglycerides, Total Cholesterol
Time Frame
Baseline, 6-Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Islam, PhD
Organizational Affiliation
New York University School of Medicine, Department of Population Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine, Dept of Population Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23749774
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.
Results Reference
background
PubMed Identifier
36273386
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.
Results Reference
derived
PubMed Identifier
24548534
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.
Results Reference
derived

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DREAM Project Community Health Worker Intervention

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