Disease Management and Educational Intervention Outcomes in High-Risk Diabetics

Diabetes Mellitus Self Management Education Clinical Trial

Official title:

Disease Management and Educational Intervention Outcomes in High-Risk Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00012662
• Other study ID #: DII 99-188
• Status: Completed
• Phase: N/A
• First received: March 14, 2001
• Last updated: April 6, 2015
• Est. completion date: December 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Self Management Education
• High Risk Diabetes
• Hyperglycemic Control

Intervention

Behavioral:
• Diabetes Self Management Education

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bradham DD, Mangan M, Warrick A, Geiger-Brown J, Reiner JI, Saunders HJ. Linking innovative nursing practice to health services research. Nurs Clin North Am. 2000 Jun;35(2):557-68. Review. — View Citation