DREAM Project Community Health Worker Intervention

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by New York University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02041598
First received: January 16, 2014
Last updated: April 7, 2014
Last verified: April 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). 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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: CHW Intervention
Other: Control - Introductory Educational Session Only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Resource links provided by NLM:


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 Lipid Profile at 6-Months [ Time Frame: Baseline, 6-Months ] [ Designated as safety issue: No ]
    HDL, LDL, Triglycerides, Total Cholesterol


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


Estimated Enrollment: 240
Study Start Date: July 2009
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Full CHW Intervention Other: CHW Intervention
Active Comparator: Control: Intro to Diabetes Session Only Other: Control - Introductory Educational Session Only

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041598

Contacts
Contact: Lindsey Riley, MPH 212.263.7328 lindsey.riley@nyumc.org
Contact: Nadia Islam, PhD 212.263.7075 nadia.islam@nyumc.org

Locations
United States, New York
New York University School of Medicine, Dept of Population Health Recruiting
New York, New York, United States, 10016
Principal Investigator: Nadia Islam, PhD         
Sub-Investigator: Chau Trinh-Shevrin, DPH         
Sub-Investigator: Michael Tanner, MD         
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: April 7, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014