Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012662
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 90 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 hospitalizationsER 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
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 90 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 hospitalizationsER 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None