Emory Latino Diabetes Education Program (ELDEP)
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 17, 2008 | ||||||||
| Last Updated Date | October 4, 2012 | ||||||||
| Start Date ICMJE | October 2008 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00793884 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Emory Latino Diabetes Education Program | ||||||||
| Official Title ICMJE | Emory Latino Diabetes Education Program | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Spanish speaking patients with Diabetes |
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| Condition ICMJE | Diabetes | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | 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. |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 800 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00793884 | ||||||||
| Other Study ID Numbers ICMJE | e13340 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Guillermo Umpierrez, Emory University | ||||||||
| Study Sponsor ICMJE | Emory University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Emory University | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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