- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00822471
Feasibility and Impact of "ABCs of Diabetes" Self-Management Education Program at an Urban Public Library
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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- What is diabetes?
- A1C and blood glucose targets
- Diabetes medications
- Hypoglycemia
- Managing Blood Pressure
- Taking your medications
- Preventing vascular complications
- Monitoring your diabetes health
- "How to Talk to your Doctor"
B. Education strategies & tools
- Role playing from "How To Talk to Your Doctor"
- Ask for test results and how to get to targets
- Prompts to schedule appointments for ADA recommended exams, tests and discuss diabetes with primary care provider
Class #2 Cholesterol and Meal Planning
A. Curriculum Content Areas:
- Managing cholesterol
- Diet, exercise & weight management
- Cholesterol medications
- Smoking cessation
- Family Meal Planning:
consistent carbohydrate
- heart healthy meals
B. Education strategies & tools
- View "Cut the Fat Back" video†
- Interactive portion size & meal planning strategies
- Prompts to query PCP for LDL-C results;
- Flyers with questions to focus PCP on ADA goals † Produced by the Health Promotion Council, Philadelphia PA hpcpa@phmc.org
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Washington Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Diabetes Mellitus, type 1 or type 2 for at least one month prior to taking the first educational class.
- 18 years old or older.
- Females and Males
- All ethnic groups.
- Must be able to read and speak English.
- Must be willing to sign informed consent to participate in the research component of the program.
- Plan on living in the District of Columbia for the next 6 to 8 months.
- Willing to attend 2 core interactive education sessions within a 6-week period.
- 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.
- Willing to attend both a pre- and a post-study outcomes data collection visit, each of which will last approximately 1 - 1 ½ hours.
- Ability and willingness to adhere to all study requirements.
- 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.
- Have access to telephone in residence to receive reminder calls for up upcoming visits.
Exclusion Criteria:
- Pregnancy.
- Non-English speaking.
- Untreated mental illness.
- History of substance abuse or alcohol abuse in the past 12 months.
- Individuals participating in a drug research study.
- 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)
- Chronic concomitant use of oral steroids.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Diabetes Self-Management Education
Education intervention with historic self-controls.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months following program completion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
increase the percentage of subjects taking medications for A1C, BP and LDL-C management and aspirin;
Time Frame: 6 months following DSME program completion
|
6 months following DSME program completion
|
increase scores on the diabetes self-efficacy scale (DES);
Time Frame: 6 months following DSME program completion
|
6 months following DSME program completion
|
increase percentage of patients with A1C, BP and LDL-C at recommended targets;
Time Frame: 6 months following program completion
|
6 months following program completion
|
Decrease the percentage of participants with self-reported ED visits and hospitalizations for severe hypoglycemia and hyperglycemia.
Time Frame: 6 months following DSME program completion
|
6 months following DSME program completion
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michelle F. Magee, MD, LRCPSI, MedStar Health Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002-288
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Disease
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted
-
Penn State UniversityAlmond Board of California; The Hershey CompanyCompletedCardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentCompleted
-
Aziyo Biologics, Inc.CompletedCardiovascular DiseaseUnited States
-
Monash UniversityCompletedCardiovascular DiseaseAustralia
Clinical Trials on Diabetes Self-Management Education
-
University of MichiganRecruiting
-
University of ArkansasPatient-Centered Outcomes Research InstituteActive, not recruitingDiabetes Mellitus, Type 2United States
-
University of MichiganNational Institutes of Health (NIH); National Institute on Aging (NIA); Blue...Completed
-
National Institute of Diabetes and Digestive and...CompletedDiabetes Mellitus, Non-Insulin-DependentUnited States
-
US Department of Veterans AffairsCompletedDiabetes Mellitus Self Management Education | Hyperglycemic Control | High Risk DiabetesUnited States
-
University of NottinghamCompletedDiabetes Mellitus, Type 2 | Health BehaviorJordan
-
Texas AgriLife Extension ServiceTexas A&M UniversityCompletedType 2 Diabetes, Hispanic/Latinos, Diabetes Self-management Education
-
Rush University Medical CenterCompleted
-
The University of Texas Health Science Center,...The Institute for Faith Health Research of DallasCompleted
-
Mutah UniversityCompleted