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| 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 |
| 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 |
| Estimated Enrollment: | 1800 |
| Study Completion Date: | December 2002 |
| Arms | Assigned Interventions |
| 1 | Behavioral: Diabetes Self Management Education |
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 |
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| United States, Maryland | |||||
| VA Maryland Health Care System, Baltimore | |||||
| Baltimore, Maryland, United States, 21201 | |||||
| Principal Investigator: | Bruce P. Hamilton, MD | VA Maryland Health Care System |
More Information
| 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 |
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