Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
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|ClinicalTrials.gov Identifier: NCT00012662|
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Self Management Education Hyperglycemic Control High Risk Diabetes||Behavioral: Diabetes Self Management Education||Not Applicable|
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.
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.
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.
Recruitment is over and final analyses are underway.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1800 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Disease Management and Educational Intervention Outcomes in High-Risk Diabetics|
|Actual Study Completion Date :||December 2002|
Behavioral: Diabetes Self Management Education
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
|United States, Kansas|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|
|Baltimore, Kansas, United States, 21201|
|Principal Investigator:||Bruce P. Hamilton, MD||Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|