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Disease Management and Educational Intervention Outcomes in High-Risk Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00012662
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diabetes Mellitus Self Management Education Hyperglycemic Control High Risk Diabetes 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
Study Completion Date : December 2002
Arms and Interventions

Arm Intervention/treatment
Arm 1 Behavioral: Diabetes Self Management Education


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012662


Locations
United States, Kansas
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Kansas, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Bruce P. Hamilton, MD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00012662     History of Changes
Other Study ID Numbers: DII 99-188
First Posted: March 16, 2001    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: February 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases