Feasibility and Impact of "ABCs of Diabetes" Self-Management Education Program at an Urban Public Library
| Tracking Information | |||||
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| First Received Date ICMJE | January 12, 2009 | ||||
| Last Updated Date | January 13, 2009 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | January 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Improvement in the percent of subjects correctly identifying guideline-recommended treatment targets for the "ABC's of Diabetes", where A = A1C < 7%; B = BP <130/80mmHg and; and C = LDL-C < 100mg/dl. [ Time Frame: 6 months following program completion ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00822471 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 | Feasibility and Impact of "ABCs of Diabetes" Self-Management Education Program at an Urban Public Library | ||||
| Official Title ICMJE | Feasibility and Impact of of "ABC's of Diabetes" Self Management Education (DSME) Program for African Americans at an Urban Public Library on A1C, Lipid Lowering Agent Prescriptions and Emergency Department Visits | ||||
| Brief Summary | A concise diabetes self-management education (DSME) program on the "ABCs of Diabetes" will be placed in an urban public library to assess the feasibility of using this community setting for the delivery of health care education in an urban African American population. Impact on knowledge of, prescriptions for, and control of blood sugar (A1C), blood pressure (BP) and LDL cholesterol (LDL-C)before and after participation in the program will be assessed. We will also examine the frequency of emergency department (ED) visits and hospitalizations for uncontrolled diabetes at 6 months post-DSME intervention. |
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| Detailed Description | A free, community-based Diabetes Learning Center was placed in a public library. Adults with diabetes (N=360) consented to participate in this prospective cohort study with historic self-controls. The small group, interactive DSME (two 2-1/2 hour classes) focused on improving CVD risk factors and enabling communication with the primary care physician. Knowledge, prescriptions, diabetes-related testing and clinical outcomes were assessed. "ABCs of Diabetes" DSME Program Class #1: A1C, Aspirin & Blood Pressure A. Curriculum Content Areas:
B. Education strategies & tools
Class #2 Cholesterol and Meal Planning A. Curriculum Content Areas:
consistent carbohydrate
B. Education strategies & tools
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Diabetes Self-Management Education
DSME intervention consisting of two interactive 2-1/2 hour classes taught by a diabetes educator focusing on the "ABCs of diabetes" and training in how to talk to your doctor. |
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| Study Arm (s) | Diabetes Self-Management Education
Education intervention with historic self-controls.
Intervention: Behavioral: Diabetes Self-Management Education |
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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 | Completed | ||||
| Enrollment ICMJE | 360 | ||||
| Completion Date | July 2005 | ||||
| Primary Completion Date | January 2005 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00822471 | ||||
| Other Study ID Numbers ICMJE | 2002-288 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Michelle F. Magee, MD, Medstar Diabetes & Research Institutes | ||||
| Study Sponsor ICMJE | Medstar Research Institute | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Medstar Research Institute | ||||
| Verification Date | January 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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