Emory Latino Diabetes Education Program (ELDEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emory University
Sponsor:
Collaborators:
Sanofi
Eli Lilly and Company
Takeda
Novo Nordisk A/S
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00793884
First received: November 17, 2008
Last updated: July 2, 2014
Last verified: June 2014
  Purpose

Latinos represent the largest minority group in the United States with a population of 35 million or 12.5%. National surveys indicate that the prevalence of type 2 diabetes is 1.9 times higher in Latinos than non-whites, and that approximately 24% percent of Latinos over the age of 45 years have diabetes. In Georgia, Latinos make up approximately 6.5% of the population. During 1990 and 2000, the prevalence of diabetes in Fulton and Dekalb counties, two of the most populated areas in Georgia and the Atlanta metropolitan area increased by 30%. Language and cultural barriers represent the two most important obstacles in educating and improving the care of Latino patients with diabetes. Less than 5% of physicians, 2% of nurses, and 2.5% of dentists in the US speak Spanish.

The Emory Latino Diabetes education program has been in existence since December 2005. Our program aims to deliver diabetes education in Spanish to the underserved Latino community in Metro Atlanta. Program participants attend an initial 2.5hr diabetes education class in Spanish. The class curriculum follows the American Association of Diabetes Educators (AADE) seven self-care behaviors: healthy eating, being active, monitoring, medication use, problem-solving and healthy coping. Participants are invited to return to a follow-up session within 6 months. Follow-sessions are held in the late afternoon. These sessions are discussion-based and include an activity such as salsa lessons and cooking demonstrations.

We would like to obtain IRB approval to analyze and publish that data we collect during our educational sessions. We would like to collect retrospective data from past participants in the program (for which we request a waiver of informed consent and HIPAA authorization), and we would like to consent current and future participants to use their data.


Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Emory Latino Diabetes Education Program

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • To describe the social and demographic characteristics of the Latino population with diabetes mellitus in Georgia [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine barriers to health care among Latinos with Diabetes in the population we serve [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine differences in clinical outcomes (hemoglobin A1C, waist circumference, BMI, blood pressure) and diabetes self-management behaviors between initial and follow-up data [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: October 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes Education
Program participants attend an initial 2.5hr diabetes education class in Spanish. The class curriculum follows the American Association of Diabetes Educators (AADE) seven self-care behaviors: healthy eating, being active, monitoring, medication use, problem-solving and healthy coping. Participants are invited to return to a follow-up session within 6 months. Follow-sessions are held in the late afternoon. These sessions are discussion-based and include an activity such as salsa lessons and cooking demonstrations.

Detailed Description:

Participants complete a questionnaire which assesses behaviors and social and demographic characteristics of the Latino community we serve. In order to track patients outcomes, at the beginning of each class we also measure A1C, blood pressure, weight, BMI and waist circumference.

Diabetes education classes and follow-up sessions are offered at Grady Memorial Hospital (Diabetes Clinic, International Medical Center), Grady North Dekalb Clinic (Chamblee), and North Fulton Regional Hospital.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Spanish speaking patients with Diabetes

Criteria

Inclusion Criteria:

  • spanish speaking patients with diabetes

Exclusion Criteria:

  • under 18 years of age
  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: NCT00793884

Contacts
Contact: Britt Rotberg Wolfe, MS, RDN, LD 404.616.7417 britt.rotberg@emory.edu
Contact: Guillermo Umpierrez, MD 4048871665 geumpie@emory.edu

Locations
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30303
Contact: Britt Rotberg Wolfe, MS, RDN, LD    404-778-1697    britt.rotberg@emory.edu   
Principal Investigator: Guillermo Umpierrez, MD         
Sponsors and Collaborators
Emory University
Sanofi
Eli Lilly and Company
Takeda
Novo Nordisk A/S
Investigators
Study Director: Britt Rotberg Wolfe, MS, RDN, LD Emory University
Principal Investigator: Guillermo Umpierrez, MD Emory University
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00793884     History of Changes
Other Study ID Numbers: IRB00013340
Study First Received: November 17, 2008
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Diabetes
Latino population

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

ClinicalTrials.gov processed this record on October 30, 2014