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DREAM Project Community Health Worker Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02041598
First Posted: January 22, 2014
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
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).

Condition Intervention
Diabetes Mellitus, Type 2 Other: CHW Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: DREAM Project Community Health Worker Intervention

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Change in Baseline Hemoglobin A1c at 6-Months [ Time Frame: Baseline, 6-Months ]
    Change in Baseline HbA1c at 6-Months


Secondary Outcome Measures:
  • Change in Baseline Perceived Social Support at 6-Months [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 6-Months ]
    HDL, LDL, Triglycerides, Total Cholesterol


Enrollment: 441
Actual Study Start Date: July 1, 2009
Study Completion Date: February 25, 2016
Primary Completion Date: February 25, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Full CHW Intervention
5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed
Other: CHW Intervention
5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period
No Intervention: Control: Intro to Diabetes Session Only
One-time, Introduction to Diabetes educational session only

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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041598


Locations
United States, New York
New York University School of Medicine, Dept of Population Health
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Nadia Islam, PhD New York University School of Medicine, Department of Population Health
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02041598     History of Changes
Other Study ID Numbers: 09-0510
P60MD000538 ( U.S. NIH Grant/Contract )
U48DP001904 ( U.S. NIH Grant/Contract )
First Submitted: January 16, 2014
First Posted: January 22, 2014
Last Update Posted: October 18, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases