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Disease Managment and Educational Intervention Outcomes in High-Risk Diabetics
This study has been completed.
Study NCT00012662   Information provided by Department of Veterans Affairs
First Received: March 14, 2001   Last Updated: May 11, 2009   History of Changes

March 14, 2001
May 11, 2009
 
 
 
 
Complete list of historical versions of study NCT00012662 on ClinicalTrials.gov Archive Site
 
 
 
Disease Managment and Educational Intervention Outcomes in High-Risk Diabetics
Disease Managment and Educational Intervention Outcomes in High-Risk Diabetics

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.

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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
  • Diabetes Mellitus Self Management Education
  • Hyperglycemic Control
  • High Risk Diabetes
Behavioral: Diabetes Self Management Education
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1800
December 2002
 

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012662
Hamilton, Bruce - Principal Investigator, Department of Veterans Affairs
DII 99-188
Department of Veterans Affairs
 
Principal Investigator: Bruce P. Hamilton, MD VA Maryland Health Care System
Department of Veterans Affairs
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP