ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Randomized Trial of Health Events Costs in Diabetic Blacks

This study has been completed.

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

MedlinePlus related topics:   Diabetes   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized
Official Title:   Project Sugar 2: Health Events Costs in Diabetic Blacks

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 of Results:

Other Publications:
Brancati FL, Whittle JC, Whelton PK, Seidler AJ, Klag MJ. The excess incidence of diabetic end-stage renal disease among blacks. A population-based study of potential explanatory factors. JAMA. 1992 Dec 2;268(21):3079-84.
 
Brancati FL, Appel LJ, Seidler AJ, Whelton PK. Effect of potassium supplementation on blood pressure in African Americans on a low-potassium diet. A randomized, double-blind, placebo-controlled trial. Arch Intern Med. 1996 Jan 8;156(1):61-7.
 
Krop JS, Coresh J, Chambless LE, Shahar E, Watson RL, Szklo M, Brancati FL. A community-based study of explanatory factors for the excess risk for early renal function decline in blacks vs whites with diabetes: the Atherosclerosis Risk in Communities study. Arch Intern Med. 1999 Aug 9-23;159(15):1777-83.
 
Hill MN, Becker DM. Roles of nurses and health workers in cardiovascular health promotion. Am J Med Sci. 1995 Dec;310 Suppl 1:S123-6. Review.
 
Shediac-Rizkallah MC, Bone LR. Planning for the sustainability of community-based health programs: conceptual frameworks and future directions for research, practice and policy. Health Educ Res. 1998 Mar;13(1):87-108. Review.
 
Levine DM, Becker DM, Bone LR, Hill MN, Tuggle MB 2nd, Zeger SL. Community-academic health center partnerships for underserved minority populations. One solution to a national crisis. JAMA. 1994 Jul 27;272(4):309-11. No abstract available.
 
Krop JS, Powe NR, Weller WE, Shaffer TJ, Saudek CD, Anderson GF. Patterns of expenditures and use of services among older adults with diabetes. Implications for the transition to capitated managed care. Diabetes Care. 1998 May;21(5):747-52.
 
Powe NR, Weiner JP, Starfield B, Stuart M, Baker A, Steinwachs DM. Systemwide provider performance in a Medicaid program. Profiling the care of patients with chronic illnesses. Med Care. 1996 Aug;34(8):798-810.
 

Study ID Numbers:   DK48117, RO1 DK48117-06, OPD-GCRC R00052
First Received:   August 10, 2001
Last Updated:   January 25, 2007
ClinicalTrials.gov Identifier:   NCT00022750
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

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers