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Clinical Trials/NCT00012662
NCT00012662
Completed
Not Applicable

Disease Management and Educational Intervention Outcomes in High-Risk Diabetics

US Department of Veterans Affairs1 site in 1 country1,800 target enrollmentMarch 16, 2001

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus Self Management Education
Sponsor
US Department of Veterans Affairs
Enrollment
1800
Locations
1
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Studies have demonstrated improved glycemic control with nurse case-management or educational care models. However, none have controlled for their independent contributions, intervened with advanced practice nurses (APN), or targeted highest risk individuals.

Detailed Description

Background: Social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Studies have demonstrated improved glycemic control with nurse case-management or educational care models. However, none have controlled for their independent contributions, intervened with advanced practice nurses (APN), or targeted highest risk individuals. Objectives: The objective of this project is to examine whether interventions of diabetes self-management education programs with or without APN case managers improve outcomes and are cost effective. Methods: Patients were randomly assigned to one of four groups: 1) Disease-management and diabetes education; 2) Disease-management alone; 3) Diabetes education alone; and 4) Routine Care. Veterans receiving primary care in VISN-5 and meeting high-risk criteria (HbA1c � 9.0%) were screened for inclusion. Patient outcome measures were collected at baseline, three months and twelve months. These included: Quality of Life (QOL), HgbAlc levels, and incidence of diabetes-related hospitalizations/ER visits. In addition, patient-level intervention costs, health care use and costs were examined. ANOVA comparisons were used to test hypotheses. Status: Recruitment is over and final analyses are underway.

Registry
clinicaltrials.gov
Start Date
March 16, 2001
End Date
December 2002
Last Updated
11 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Type 2 diabetes HbA1C. 9.0%, consistent diabetes tx over last 3 months.

Exclusion Criteria

  • Homelessness-not able to be consistently contacted; Dementia, Planned Movement from area; Unstable angina, Myocardial Infarction in past 3 months; Stroke; Two or more seizures in last 3 months; document alcoholism or drug abuse; Pregnant or planning to become pregnant in next 12 months; Severe immunodeficiency or cirrhosis of the liver; Type 1 diabetes; blind individuals; psychosis; pancreatitis with secondary diabetes; Renal disease.

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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