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

January 16, 2014
November 5, 2014
July 2009
January 2016   (final data collection date for primary outcome measure)
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
  • 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
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 ] [ 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
  • 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
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: 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.
 
Enrolling by invitation
240
January 2017
January 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.
Both
25 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02041598
i09-0510, P60MD000538, U48DP001904
No
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
November 2014

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