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	Treatment or Intervention
Diabetes Mellitus, Type 2	Behavior: Nurse Case Manager and Community Health Worker Team

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Maryland
      The Johns Hopkins Medical Institutions, Baltimore,  Maryland,  21205,  United States; Recruiting

Study chairs or principal investigators

Frederick L. Brancati, MD, MHS,  Principal Investigator,  The Johns Hopkins Medical Institutions   

Study ID Numbers:  brancatif; RO1 DK48117-06; OPD-GCRC R00052
Record last reviewed:  July 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022750
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27