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

NCT00822471 | Completed

• 1 other identifier: 2002-288
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Cardiovascular Disease

Keywords

Diabetes; Self-Management Education; Library; Emergency Department Visits; African American; CVD prevention; Prevention; Uncontrolled diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• increase the percentage of subjects taking medications for A1C, BP and LDL-C management and aspirin;

  6 months following DSME program completion

• increase scores on the diabetes self-efficacy scale (DES);

  6 months following DSME program completion

• increase percentage of patients with A1C, BP and LDL-C at recommended targets;

  6 months following program completion

• Decrease the percentage of participants with self-reported ED visits and hospitalizations for severe hypoglycemia and hyperglycemia.

  6 months following DSME program completion

Study Arms (1)

Diabetes Self-Management Education

OTHER

Education intervention with historic self-controls.

Behavioral: Diabetes Self-Management Education

Interventions

Diabetes Self-Management Education BEHAVIORAL

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.

Diabetes Self-Management Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Diabetes Mellitus, type 1 or type 2 for at least one month prior to taking the first educational class.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michelle F. Magee, MD, LRCPSI

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Georgetown University School of Medicine

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 14, 2009
• Study Start: January 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: July 1, 2005
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

US (1)