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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00022750 |
Purpose
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 | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Behavioral: Nurse Case Manager and Community Health Worker Team |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized |
| Official Title: | Project Sugar 2: Health Events Costs in Diabetic Blacks |
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | DK48117, RO1 DK48117-06, OPD-GCRC R00052 |
| Study First Received: | August 10, 2001 |
| Last Updated: | January 25, 2007 |
| ClinicalTrials.gov Identifier: | NCT00022750 History of Changes |
| Health Authority: | United States: Federal Government |
|
Type 2 Diabetes Mellitus Nurse Case Manager Community Health Worker |
Behavioral Interventions Cost-effectiveness Randomized trial |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
|
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |