Clarksdale Diabetes and Metabolism Clinic CHEC Study
| Tracking Information | |||||
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| First Received Date ICMJE | January 28, 2008 | ||||
| Last Updated Date | May 11, 2009 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hgb A1C and BMI measurements will improve [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00791453 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clarksdale Diabetes and Metabolism Clinic CHEC Study | ||||
| Official Title ICMJE | Clarksdale Diabetes and Metabolism Clinic Consumer Health Education Center Study | ||||
| Brief Summary | This study will involve established clinic patients. The Rapid Estimate of Adult Literacy in Medicine will be administered during patients' regular clinic visits. Patients will then be referred to the Consumer Health Education Center (CHEC)by healthcare providers who will fill out a referral form. The form will be given the the CHEC health educator who will assist patients in finding literacy-appropriate health information. BMI and Hgb A1c values will be compared after 3 months and 6 months to baseline values. It is hypothesized that objective assessment of patient use of literacy-appropriate, health information from the Clarksdale Diabetes and Metabolism Clinic CHEC will improve Hgb A1c and BMI values among patients. |
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| Detailed Description | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Biospecimen | Retention: Samples Without DNA Description: No biospecimens are retained |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Established patients at a diabetes clinic. |
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| Condition ICMJE | Diabetes | ||||
| Intervention ICMJE | Behavioral: Education
Patients will receive literacy appropriate health information. |
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| Study Group/Cohort (s) | I
Established patients at the Clarksdale Diabetes and Metabolism Center
Intervention: Behavioral: Education |
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| Publications * | |||||
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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 | Completed | ||||
| Enrollment ICMJE | 55 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00791453 | ||||
| Other Study ID Numbers ICMJE | 2008-0001, NO1-LM-6-3502 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jacinda Roach/Assistant Professor, Deptartment of Medicine,, The University of Mississippi Medical | ||||
| Study Sponsor ICMJE | University of Mississippi Medical Center | ||||
| Collaborators ICMJE | National Library of Medicine (NLM) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Mississippi Medical Center | ||||
| Verification Date | May 2009 | ||||
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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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