Feasibility and Impact of "ABCs of Diabetes" Self-Management Education Program at an Urban Public Library

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822471
• Other study ID #: 2002-288
• Status: Completed
• Phase: N/A
• Start date: January 2003
• Est. completion date: July 2005

Study information

• Verified date: August 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: July 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (15)

Lead Sponsor	Collaborator
Medstar Health Research Institute	American Diabetes Association, Aventis Pharmaceuticals, Bayer, CareFirst BlueCross Blue Shield;, Charles and Mary Latham Trust Fund;, District of Columbia, Department of Health Block Grants Program;, Eli Lilly and Company, Hewlett-Packard, Medstar Diabetes Institute;, Meltzer Entities;, NBC Washington, Novo Nordisk A/S, Pfizer, Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months following program completion
Secondary	increase the percentage of subjects taking medications for A1C, BP and LDL-C management and aspirin;		6 months following DSME program completion
Secondary	increase scores on the diabetes self-efficacy scale (DES);		6 months following DSME program completion
Secondary	increase percentage of patients with A1C, BP and LDL-C at recommended targets;		6 months following program completion
Secondary	Decrease the percentage of participants with self-reported ED visits and hospitalizations for severe hypoglycemia and hyperglycemia.		6 months following DSME program completion