Evaluation of Diabetes Self-Management Consultant Care

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Evaluation of Diabetes Self-Management Consultant Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109720
• Other study ID #: 62323 (completed)
• Status: Completed
• Phase: N/A
• First received: May 2, 2005
• Last updated: January 14, 2010
• Start date: August 2002
• Est. completion date: July 2007

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Diabetes Self-Management Consultant
services of a Diabetes Self-Management Consultant
• Enhanced Usual Care Control Group
Usual care plus results of metabolic assessments obtained during the study

Locations

Country	Name	City	State
United States	University of Michigan, Department of Family Medicine Clinics	Ann Arbor	Michigan
United States	Detroit Health Department	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Detroit Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose level		two years	No
Secondary	Diabetes Related Quality of life		two years	No