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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
January 16, 2014
January 22, 2014
October 18, 2017
July 1, 2009
February 25, 2016   (Final data collection date for primary outcome measure)
Change in Baseline Hemoglobin A1c at 6-Months [ Time Frame: Baseline, 6-Months ]
Change in Baseline HbA1c at 6-Months
  • Change in Baseline Hemoglobin A1c at 6-Months [ Time Frame: Baseline, 6-Months ]
  • Change in Baseline Lipid Profile at 6-Months [ Time Frame: Baseline, 6-Months ]
    HDL, LDL, Triglycerides, Total Cholesterol
Complete list of historical versions of study NCT02041598 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
DREAM Project Community Health Worker Intervention
DREAM Project Community Health Worker Intervention
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).
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Diabetes Mellitus, Type 2
Other: CHW Intervention
5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period
  • Experimental: Full CHW Intervention
    5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed
    Intervention: Other: CHW Intervention
  • No Intervention: Control: Intro to Diabetes Session Only
    One-time, Introduction to Diabetes educational session only

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
441
February 25, 2016
February 25, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
25 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02041598
09-0510
P60MD000538 ( U.S. NIH Grant/Contract )
U48DP001904 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
New York University School of Medicine
New York University School of Medicine
National Institute on Minority Health and Health Disparities (NIMHD)
Principal Investigator: Nadia Islam, PhD New York University School of Medicine, Department of Population Health
New York University School of Medicine
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP