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

NCT ID: NCT00822471

Last Updated: 2020-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-07-31

Brief Summary

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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.

Detailed Description

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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 [email protected]

Conditions

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Diabetes Cardiovascular Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Diabetes Self-Management Education

Education intervention with historic self-controls.

Group Type OTHER

Diabetes Self-Management Education

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Diabetes Institute;

UNKNOWN

Sponsor Role collaborator

American Diabetes Association

OTHER

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

CareFirst BlueCross Blue Shield;

UNKNOWN

Sponsor Role collaborator

District of Columbia, Department of Health Block Grants Program;

UNKNOWN

Sponsor Role collaborator

Charles and Mary Latham Trust Fund;

UNKNOWN

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Hewlett-Packard

INDUSTRY

Sponsor Role collaborator

Meltzer Entities;

UNKNOWN

Sponsor Role collaborator

NBC Washington

OTHER

Sponsor Role collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Michelle Magee

Professor of Medicine, Georgetown University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle F. Magee, MD, LRCPSI

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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Washington Hospital Center

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

Site Status

Countries

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United States

Other Identifiers

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2002-288

Identifier Type: -

Identifier Source: org_study_id

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