Feasibility and Impact of "ABCs of Diabetes" Self-Management Education Program at an Urban Public Library
NCT00822471
ABOUT THIS STUDY
FOR MORE INFORMATION
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Pfizer Clinical Trials Contact Center
1-800-718-1021
1. Diagnosis of Diabetes Mellitus, type 1 or type 2 for at least one month prior to taking the first educational class.
2. 18 years old or older.
3. Females and Males
4. All ethnic groups.
5. Must be able to read and speak English.
6. Must be willing to sign informed consent to participate in the research component of the program.
7. Plan on living in the District of Columbia for the next 6 to 8 months.
8. Willing to attend 2 core interactive education sessions within a 6-week period.
9. Willing to have a fingerstick performed to obtain blood for A1C and cholesterol determinations prior to and 6 months after completion of the educational sessions.
10. Willing to attend both a pre- and a post-study outcomes data collection visit, each of which will last approximately 1 - 1 ½ hours.
11. Ability and willingness to adhere to all study requirements.
12. Participant must have active health insurance coverage or self pay and have regular visits to their primary care physician. Interested parties who do not have health insurance will be referred to DHHS for assistance in applying for Medicare or Medicaid when applicable.
13. Have access to telephone in residence to receive reminder calls for up upcoming visits.
1. Pregnancy.
2. Non-English speaking.
3. Untreated mental illness.
4. History of substance abuse or alcohol abuse in the past 12 months.
5. Individuals participating in a drug research study.
6. Presence of concomitant condition or circumstances which, in the opinion of the
investigator, could interfere with participation in the study, glycemic control or
interpretation of the data collected. (e.g. active malignance; HIV/AIDS)
7. Chronic concomitant use of oral steroids.
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- Washington, District of Columbia
Descriptive Information | ||||
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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. | |||
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 ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
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. | |||
Study Arms ICMJE | Diabetes Self-Management Education
Education intervention with historic self-controls. Intervention: Behavioral: Diabetes Self-Management Education | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 360 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2005 | |||
Actual Primary Completion Date | January 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00822471 | |||
Other Study ID Numbers ICMJE | 2002-288 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Michelle Magee, Medstar Health Research Institute | |||
Study Sponsor ICMJE | Medstar Health Research Institute | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Medstar Health Research Institute | |||
Verification Date | August 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |