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
  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: Allocation: Randomized
Primary Purpose: Prevention
Official Title: Project Sugar 2: Health Events Costs in Diabetic Blacks

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 800
Study Start Date: October 2000
Estimated Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022750

Locations
United States, Maryland
The Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Investigators
Principal Investigator: Frederick L. Brancati, MD, MHS The Johns Hopkins Medical Institutions
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00022750     History of Changes
Other Study ID Numbers: DK48117 (completed), RO1 DK48117-06, OPD-GCRC R00052
Study First Received: August 10, 2001
Last Updated: January 14, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Type 2 Diabetes Mellitus
Nurse Case Manager
Community Health Worker
Behavioral Interventions
Cost-effectiveness
Randomized trial

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 21, 2014