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

August 21, 2020 updated by: Michelle Magee, Medstar Health Research Institute

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

January 12, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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