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Improving Health Outcomes of Diabetic Veterans: A Diabetic Self-Management Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00013052
First Posted: March 16, 2001
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
Control of the blood sugar prevents complications and results in extra years of life in patients with diabetes. Practice Guidelines delineating specific ways physicians manage diabetes have been outlined. Missing are guidelines for health care providers to encourage patients to take responsibility for their diabetes. Traditional patient education models have been ineffective in managing diabetic persons because they have relied upon information given alone and are disease centered rather than patient centered. This study will explore the role of self-efficacy in helping veterans move toward healthy behaviors.

Condition Intervention
Diabetes Behavioral: Peer led classes. Led by trained veterans with a chronic disease.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Improving Health Outcomes of Diabetic Veterans: A Diabetic Self-Management Program

Further study details as provided by VA Office of Research and Development:

Estimated Enrollment: 2068
Study Completion Date: September 2002
Arms Assigned Interventions
Arm 1 Behavioral: Peer led classes. Led by trained veterans with a chronic disease.

Detailed Description:

Background:

Control of the blood sugar prevents complications and results in extra years of life in patients with diabetes. Practice Guidelines delineating specific ways physicians manage diabetes have been outlined. Missing are guidelines for health care providers to encourage patients to take responsibility for their diabetes. Traditional patient education models have been ineffective in managing diabetic persons because they have relied upon information given alone and are disease centered rather than patient centered. This study will explore the role of self-efficacy in helping veterans move toward healthy behaviors.

Objectives:

The long-term objectives are to: 1) increase recognition of veteran�s responsibility for health; 2) develop more effective skills in managing chronic conditions; and 3) explore the role of self-efficacy in facilitating improvements in health behaviors and health care utilization.

Methods:

This is a prospective, randomized controlled clinical trial of 2,068 cognitively intact, diabetic veterans. The outcome measures (health behaviors, self-efficacy, health status and health care utilization) will be measured using self-rated scales developed and tested by Lorig and colleagues from Stanford University. Glucose levels and BMI changes will be evaluated using information documented in the medical record.

Status:

Enrollment (a total of 326 patients) is closed. All necessary data have been received and are being analyzed.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cognitively intact diabetic veterans.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013052


Locations
United States, Florida
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
West Palm Beach VA Medical Center, West Palm Beach, FL
West Palm Beach, Florida, United States, 33410
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Virginia Nodhturft, EdD RN James A. Haley Veterans' Hospital, Tampa, FL
Principal Investigator: Carolee A. DeVito, PhD MPH Miami VA Healthcare System, Miami, FL
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00013052     History of Changes
Other Study ID Numbers: DII 99-097
First Submitted: March 14, 2001
First Posted: March 16, 2001
Last Update Posted: April 7, 2015
Last Verified: February 2007