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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00013052
• Other study ID #: DII 99-097
• Status: Completed
• Phase: N/A
• First received: March 14, 2001
• Last updated: April 6, 2015
• Est. completion date: September 2002

Study information

• Verified date: February 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2068
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Cognitively intact diabetic veterans.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Peer led classes. Led by trained veterans with a chronic disease.

Locations

Country	Name	City	State
United States	Miami VA Healthcare System, Miami, FL	Miami	Florida
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida
United States	West Palm Beach VA Medical Center, West Palm Beach, FL	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Nodhturft V, Schneider JM, Hebert P, Bradham DD, Bryant M, Phillips M, Russo K, Goettelman D, Aldahondo A, Clark V, Wagener S. Chronic disease self-management: improving health outcomes. Nurs Clin North Am. 2000 Jun;35(2):507-18. — View Citation