Randomized Trial of Health Events Costs in Diabetic Blacks

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00022750
First received: August 10, 2001
Last updated: January 14, 2010
Last verified: January 2010

August 10, 2001
January 14, 2010
October 2000
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Complete list of historical versions of study NCT00022750 on ClinicalTrials.gov Archive Site
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Randomized Trial of Health Events Costs in Diabetic Blacks
Project Sugar 2: Health Events Costs in Diabetic Blacks

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.

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Interventional
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Allocation: Randomized
Primary Purpose: Prevention
Diabetes Mellitus, Type 2
Behavioral: Nurse Case Manager and Community Health Worker Team
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
May 2005
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Inclusion Criteria:

  • African American male or female aged 30 years or older diagnosed with type 2 diabetes mellitus
  • Able to provide 2 contact persons outside his/her household with active, verified telephone numbers

Exclusion Criteria:

  • Mentally incompetent to give informed consent
  • Refuses to give informed consent
  • Comorbid health condition likely to lead to death in next 24 months
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022750
DK48117 (completed), RO1 DK48117-06, OPD-GCRC R00052
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Frederick L. Brancati, MD, MHS The Johns Hopkins Medical Institutions
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP