Randomized Trial of Health Events Costs in Diabetic Blacks
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT00022750
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 800
- Starts
- 2000-10-01
- Expected to finish
- 2005-05-01
- Last updated by the study team
- 2010-01-15
Who can join
Age: 30 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Mentally incompetent to give informed consent
- Refuses to give informed consent
- Comorbid health condition likely to lead to death in next 24 months
Where it is running
- The Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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