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

This study has been completed.
Sponsor:
Collaborators:
Medstar Diabetes Institute;
American Diabetes Association
Bayer
CareFirst BlueCross Blue Shield;
District of Columbia, Department of Health Block Grants Program;
Charles and Mary Latham Trust Fund;
Eli Lilly and Company
Hewlett-Packard
Meltzer Entities;
NBC Washington
Novo Nordisk A/S
Aventis Pharmaceuticals
Takeda Pharmaceuticals North America, Inc.
Washington Hospital Center
Pfizer
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00822471
First received: January 12, 2009
Last updated: January 13, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
Diabetes
Cardiovascular Disease
Behavioral: Diabetes Self-Management Education

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • increase the percentage of subjects taking medications for A1C, BP and LDL-C management and aspirin; [ Time Frame: 6 months following DSME program completion ] [ Designated as safety issue: No ]
  • increase scores on the diabetes self-efficacy scale (DES); [ Time Frame: 6 months following DSME program completion ] [ Designated as safety issue: No ]
  • increase percentage of patients with A1C, BP and LDL-C at recommended targets; [ Time Frame: 6 months following program completion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 360
Study Start Date: January 2003
Study Completion Date: July 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Diabetes Self-Management Education
Education intervention with historic self-controls.
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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822471

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
Medstar Diabetes Institute;
American Diabetes Association
Bayer
CareFirst BlueCross Blue Shield;
District of Columbia, Department of Health Block Grants Program;
Charles and Mary Latham Trust Fund;
Eli Lilly and Company
Hewlett-Packard
Meltzer Entities;
NBC Washington
Novo Nordisk A/S
Aventis Pharmaceuticals
Takeda Pharmaceuticals North America, Inc.
Washington Hospital Center
Pfizer
Investigators
Principal Investigator: Michelle F. Magee, MD, LRCPSI Medstar Research Institute
  More Information

No publications provided

Responsible Party: Michelle F. Magee, MD, Medstar Diabetes & Research Institutes
ClinicalTrials.gov Identifier: NCT00822471     History of Changes
Other Study ID Numbers: 2002-288
Study First Received: January 12, 2009
Last Updated: January 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
Diabetes
Self-Management Education
Library
Emergency Department Visits
African American
CVD prevention
Prevention
Uncontrolled diabetes

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014