Evaluation of Diabetes Self-Management Consultant Care - Full Text View

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

MedlinePlus related topics:

Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Evaluation of Diabetes Self-Management Consultant Care

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
1: Experimental 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
2: Active Comparator 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

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

Locations


United States, Michigan
	Detroit Health Department
	Detroit, Michigan, United States, 48202
	University of Michigan, Department of Family Medicine Clinics
	Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Detroit Department of Health

Investigators


Principal Investigator:	Robert Anderson, Ed. D.	Department of Medical Education, University of Michigan

More Information

Publications:

Heisler M, Vijan S, Anderson RM, Ubel PA, Bernstein SJ, Hofer TP. When do patients and their physicians agree on diabetes treatment goals and strategies, and what difference does it make? J Gen Intern Med. 2003 Nov;18(11):893-902.

Funnell MM, Anderson RM. Changing office practice and health care systems to facilitate diabetes self-management. Curr Diab Rep. 2003 Apr;3(2):127-33. Review.

Funnell MM, Anderson RM. Patient empowerment: a look back, a look ahead. Diabetes Educ. 2003 May-Jun;29(3):454-8, 460, 462 passim. Review. No abstract available.

Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003 May;26(5):1641-2. No abstract available.

Funnell MM, Anderson RM. Working toward the next generation of diabetes self-management education. Am J Prev Med. 2002 May;22(4 Suppl):3-5. No abstract available.

Anderson RM, Funnell MM. Compliance and adherence are dysfunctional concepts in diabetes care. Diabetes Educ. 2000 Jul-Aug;26(4):597-604. Review.

Responsible Party:	University of Michigan Medical School ( Robert M Anderson EdD Professor )
Study ID Numbers:	62323
First Received:	May 2, 2005
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00109720
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

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 October 07, 2008

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Detroit Department of Health
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00109720