Viewing Study NCT00022750



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Study NCT ID: NCT00022750
Status: COMPLETED
Last Update Posted: 2010-01-15
First Post: 2001-08-10

Brief Title: Randomized Trial of Health Events Costs in Diabetic Blacks
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization: National Institute of Diabetes and Digestive and Kidney Diseases NIDDK

Study Overview

Official Title: Project Sugar 2 Health Events Costs in Diabetic Blacks
Status: COMPLETED
Status Verified Date: 2010-01
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: Diabetes mellitus imposes a major burden on the public health of the United States leading annually to over 300000 deaths and over 130 billion in costs This burden falls disproportionately upon ethnic minority groups particularly African Americans who are at excess risk for the development of type 2 diabetes and for a variety of its most serious complications Suboptimal health care - in terms of access quality and adherence -appears to be an important contributing factor Prior work suggests two possible approaches aimed at prevention to enhance risk factor control in outpatients with type 2 diabetes One approach uses Nurse Case Managers NCMs to coordinate care plans with the provider team following protocolsclinical guidelines and algorithms designed to guide treatment including initiating and adjusting drug therapy enhancing continuity of care promoting interventions and self-management which include educational and behavioral strategies incorporating feedback and self-regulation Another approach uses Community Health Workers CHWs to enhance culturally sensitive outreach linkage and monitoring service to provide important patient and family education and to improve access to and continuity of care Results indicate that this intensive team approach compared to usual care alone produces substantial improvements in metabolic control However the cost-effectiveness of such interventions is unknown in the real-world

This has led to our current study a randomized controlled trial within a managed care organization to determine the effects of a NCMCHW team on metabolic control on the occurrence of diabetes-related health events health care utilization and on direct health care costs The participants will be African American adults with type 2 diabetes who receive primary care within a managed care organization in inner-city Baltimore
Detailed Description: None

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
Secondary IDs
Secondary ID Type Domain Link
OPD-GCRC R00052 US NIH GrantContract None httpsreporternihgovquickSearchR01DK048117-06
R01DK048117-06 NIH None None