DREAM Project Community Health Worker Intervention

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02041598
First received: January 16, 2014
Last updated: November 5, 2014
Last verified: November 2014
  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: 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 ] [ Designated as safety issue: No ]
    Change in Baseline HbA1c at 6-Months


Secondary Outcome Measures:
  • Change in Baseline Perceived Social Support at 6-Months [ Time Frame: Baseline, 6-Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    HDL, LDL, Triglycerides, Total Cholesterol


Estimated Enrollment: 240
Study Start Date: July 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Nadia Islam, PhD New York University School of Medicine, Department of Population Health
  More Information

Additional Information:
Publications:
Additional 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: i09-0510, P60MD000538, U48DP001904
Study First Received: January 16, 2014
Last Updated: November 5, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2015