Clinical trial NCT00013052: Improving Health Outcomes of Diabetic Veterans: A Diabetic Self-Management Program
Official title: Improving Health Outcomes of Diabetic Veterans: A Diabetic Self-Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 2068
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief 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.

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 criteria: Inclusion Criteria:

Cognitively intact diabetic veterans.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami VA Healthcare System, Miami, FL
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: West Palm Beach
country: United States
facility: West Palm Beach VA Medical Center, West Palm Beach, FL
state: Florida
Study officials:
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
name: Virginia Nodhturft, EdD RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami VA Healthcare System, Miami, FL
name: Carolee A. DeVito, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.