Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
Diabetes Mellitus Self Management Education
High Risk Diabetes
Behavioral: Diabetes Self Management Education
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Disease Management and Educational Intervention Outcomes in High-Risk Diabetics|
|Study Completion Date:||December 2002|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|