DREAM Project Community Health Worker Intervention

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

DREAM Project Community Health Worker Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041598
• Other study ID #: 09-0510
• Secondary ID: P60MD000538U48DP
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: October 16, 2017
• Start date: July 1, 2009
• Est. completion date: February 25, 2016

Study information

• Verified date: October 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: February 25, 2016
• Est. primary completion date: February 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• CHW Intervention
5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period

Locations

Country	Name	City	State
United States	New York University School of Medicine, Dept of Population Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Islam NS, Wyatt LC, Patel SD, Shapiro E, Tandon SD, Mukherji BR, Tanner M, Rey MJ, Trinh-Shevrin C. Evaluation of a community health worker pilot intervention to improve diabetes management in Bangladeshi immigrants with type 2 diabetes in New York City. Diabetes Educ. 2013 Jul-Aug;39(4):478-93. doi: 10.1177/0145721713491438. Epub 2013 Jun 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline Hemoglobin A1c at 6-Months	Change in Baseline HbA1c at 6-Months	Baseline, 6-Months
Secondary	Change in Baseline Perceived Social Support at 6-Months	Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint	Baseline, 6-Months
Secondary	Change in Baseline Perceived Benefits & Barriers at 6-Months	Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint	Baseline, 6-Months
Secondary	Change in Baseline Self-Efficacy at 6-Months	Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint	Baseline, 6-Months
Secondary	Change in Baseline Access to / Utilization of healthcare at 6-Months	Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint	Baseline, 6-Months
Secondary	Change in Baseline Diabetic Management Practices & Knowledge at 6-Months	Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint	Baseline, 6-Months
Secondary	Change in Baseline Engagement in Physical Activity & Healthy eating at 6-Months	Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint	Baseline, 6-Months
Secondary	Change in Baseline Lipid Profile at 6-Months	HDL, LDL, Triglycerides, Total Cholesterol	Baseline, 6-Months