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

NCT00822471

Last updated date
Study Location
Washington Hospital Center
Washington, District of Columbia, 20010, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes, Cardiovascular Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Diabetes, Cardiovascular DiseaseFeasibility and Impact of "ABCs of Diabetes" Self-Management Education Program at an Urban Public Library
NCT00822471
  1. Washington, District of Columbia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Feasibility and Impact of "ABCs of Diabetes" Self-Management Education Program at an Urban Public Library
Official Title  ICMJE 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
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.
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 [email protected]
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes
  • Cardiovascular Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Diabetes Self-Management Education
Education intervention with historic self-controls.
Intervention: Behavioral: Diabetes Self-Management Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2009)
360
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00822471
Other Study ID Numbers  ICMJE 2002-288
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michelle Magee, Medstar Health Research Institute
Study Sponsor  ICMJE Medstar Health Research Institute
Collaborators  ICMJE
  • 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.
  • Pfizer
Investigators  ICMJE
Principal Investigator:Michelle F. Magee, MD, LRCPSIMedstar Health Research Institute
PRS Account Medstar Health Research Institute
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP