ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Disease Managment and Educational Intervention Outcomes in High-Risk Diabetics

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012662
  Purpose

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.


Condition Intervention
Diabetes Mellitus Self Management Education
Hyperglycemic Control
High Risk Diabetes
Behavioral: Diabetes Self Management Education

MedlinePlus related topics:   Diabetes   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:   Disease Managment and Educational Intervention Outcomes in High-Risk Diabetics

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:   1800
Study Completion Date:   December 2002

Arms Assigned Interventions
1 Behavioral: Diabetes Self Management Education

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012662

Locations
United States, Maryland
VA Maryland Health Care System, Baltimore    
      Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

Investigators
Principal Investigator:     Bruce P. Hamilton, MD     VA Maryland Health Care System    
  More Information


Publications of Results:

Responsible Party:   Department of Veterans Affairs ( Hamilton, Bruce - Principal Investigator )
Study ID Numbers:   DII 99-188
First Received:   March 14, 2001
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00012662
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers