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Home > "R" Clinical Trials Conditions > Randomized Trial of Health Events Costs in Diabetic Blacks  Randomized Trial of Health Events Costs in Diabetic Blacks
Randomized Trial of Health Events Costs in Diabetic Blacks
For Condition: Diabetes Mellitus, Type 2
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized
Minimum Age/Maximum Age: 30 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 800
Location and Contact Information:
Overall Study Official:
FrederickBrancati, Principal Investigator, The Johns Hopkins Medical Institutions
The Johns Hopkins Medical Institutions *Recruiting*
Baltimore, Maryland, 21205
United States
Recruiting Marian Batts-Turner 410-614-4096
Additional Information:
Study ID Numbers: brancatif; OPD-GCRC R00052,RO1 DK48117-06
Study Start Date: October 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022750
Other Diabetes Mellitus, Type 2 Studies:
1. Insulin Resistance and Insulin Secretion
2. Evaluation of the Bioavailability of Pramlintide
3. Evaluation of the Effect of Pramlintide on Satiety and Food Intake
4. Pilot Study of Vedic Medicine for Type 2 Diabetes
5. Lifestyle interventions to reduce diabetes risk
Related Studies:
Other Diabetes Mellitus, Type 2 Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Randomized Trial of Health Events Costs in Diabetic Blacks
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