Randomized Trial of Health Events Costs in Diabetic Blacks
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00022750|
Recruitment Status : Completed
First Posted : August 10, 2001
Last Update Posted : January 15, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Nurse Case Manager and Community Health Worker Team||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||800 participants|
|Official Title:||Project Sugar 2: Health Events Costs in Diabetic Blacks|
|Study Start Date :||October 2000|
|Study Completion Date :||May 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022750
|United States, Maryland|
|The Johns Hopkins Medical Institutions|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Frederick L. Brancati, MD, MHS||The Johns Hopkins Medical Institutions|