Clinical Trials Directory

Trials / Completed

CompletedNCT00022750

Randomized Trial of Health Events Costs in Diabetic Blacks

Project Sugar 2: Health Events Costs in Diabetic Blacks

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
800 (planned)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Sex
All
Age
30 Years
Healthy volunteers
Not accepted

Summary

Diabetes mellitus imposes a major burden on the public health of the United States, leading annually to over 300,000 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 protocols/clinical 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 NCM/CHW 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALNurse Case Manager and Community Health Worker Team

Timeline

Start date
2000-10-01
Completion
2005-05-01
First posted
2001-08-10
Last updated
2010-01-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00022750. Inclusion in this directory is not an endorsement.