Diabetes Mellitus Self Management Education Clinical Trial
Official title:
Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment