Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Diabetes Self-Management Consultant Care

This study has been completed.
Sponsor:
Collaborator:
Detroit Department of Health
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00109720
First received: May 2, 2005
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to find out if Self-Management Consultant (SMC) intervention will be more effective than usual care in improving blood glucose control and diabetes-related quality of life for adults with type 2 diabetes.


Condition Intervention
Type 2 Diabetes Mellitus
Behavioral: Diabetes Self-Management Consultant
Behavioral: Enhanced Usual Care Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Diabetes Self-Management Consultant Care

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Blood glucose level [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes Related Quality of life [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: August 2002
Study Completion Date: July 2007
Arms Assigned Interventions
Experimental: 1
Patients in the experimental group received the services of a Diabetes Self-Management Consultant (DSC)
Behavioral: Diabetes Self-Management Consultant
services of a Diabetes Self-Management Consultant
Active Comparator: 2
This Arm was a Enhanced Usual Care Control group who continued with their usual care but also they and their physicians received the results of all metabolic assessments obtained during the study.
Behavioral: Enhanced Usual Care Control Group
Usual care plus results of metabolic assessments obtained during the study

Detailed Description:

This study is designed to compare the effectiveness of a diabetes Self-Management Consultant (SMC) intervention for adults with type 2 diabetes with unsatisfactory glucose control (i.e., HbA1c ≥ 8%--the value chosen as "high risk" by the Diabetes Quality Improvement Project which is an initiative of the Health Care Financing Administration, the American Diabetes Association, and the Foundation for Accountability) to a control group selected using the same criteria. The SMC intervention will be implemented and evaluated in two different health care systems serving two distinct populations of patients with diabetes. After signing the Informed Consent document, subjects will be randomized to the SMC intervention or a control group. All subjects in the study will complete a baseline assessment of their diabetes care and health status.

Subjects randomized to the SMC intervention will have an individual meeting with the SMC to review and refine a self-management plan based on the subject's priorities and goals. These subjects will receive individual follow-up and support during the year, through monthly phone calls and an annual meeting with the SMC and their primary care physician. Subjects randomized to the control group will receive usual care following their baseline and their 12-, 24-, and 36-month assessments. Unlike most nurse-manager studies, the SMC's interactions with patient care will use a theory-based behavioral approach with which we have extensive experience. The study is designed to evaluate the effectiveness of the SMC intervention compared to usual care.

All records will be handled confidentially. Lab results and personal data will be linked by a research specific identifier code.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults over age 21 diagnosed with type 2 diabetes for at least one year.

Exclusion Criteria:

  • Patients under psychiatric care
  • Currently pregnant
  • Those who have not been diagnosed with type 2 diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109720

Locations
United States, Michigan
University of Michigan, Department of Family Medicine Clinics
Ann Arbor, Michigan, United States, 48109
Detroit Health Department
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Detroit Department of Health
Investigators
Principal Investigator: Robert Anderson, Ed. D. Department of Medical Education, University of Michigan
  More Information

Publications:
Responsible Party: Robert M Anderson EdD Professor, University of Michigan Medical School
ClinicalTrials.gov Identifier: NCT00109720     History of Changes
Other Study ID Numbers: 62323 (completed)
Study First Received: May 2, 2005
Last Updated: January 14, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Diabetes
Self Management
Type 2 diabetes

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

ClinicalTrials.gov processed this record on November 25, 2014