Evaluation of Diabetes Self-Management Consultant Care

NCT ID: NCT00109720

Last Updated: 2010-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2007-07-31

Brief 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.

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients in the experimental group received the services of a Diabetes Self-Management Consultant (DSC)

Group Type: EXPERIMENTAL

Diabetes Self-Management Consultant

Intervention Type: BEHAVIORAL

services of a Diabetes Self-Management Consultant

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care Control Group

Intervention Type: BEHAVIORAL

Usual care plus results of metabolic assessments obtained during the study

Interventions

Diabetes Self-Management Consultant

services of a Diabetes Self-Management Consultant

Intervention Type: BEHAVIORAL

Enhanced Usual Care Control Group

Usual care plus results of metabolic assessments obtained during the study

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Detroit Department of Health

OTHER

Sponsor Role: collaborator

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

NIH

Sponsor Role: lead

Responsible Party

University of Michigan Medical School

Principal Investigators

Robert Anderson, Ed. D.

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Education, University of Michigan

Locations

University of Michigan, Department of Family Medicine Clinics

Ann Arbor, Michigan, United States

Detroit Health Department

Detroit, Michigan, United States

Countries

United States

References

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. doi: 10.1046/j.1525-1497.2003.21132.x.

Reference Type: BACKGROUND

PMID: 14687274 (View on PubMed)

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. doi: 10.1007/s11892-003-0036-7.

Reference Type: BACKGROUND

PMID: 12728638 (View on PubMed)

Funnell MM, Anderson RM. Patient empowerment: a look back, a look ahead. Diabetes Educ. 2003 May-Jun;29(3):454-8, 460, 462 passim. doi: 10.1177/014572170302900310. No abstract available.

Reference Type: BACKGROUND

PMID: 12854337 (View on PubMed)

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. doi: 10.2337/diacare.26.5.1641-a. No abstract available.

Reference Type: BACKGROUND

PMID: 12716841 (View on PubMed)

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. doi: 10.1016/s0749-3797(02)00431-2. No abstract available.

Reference Type: BACKGROUND

PMID: 11985929 (View on PubMed)

Anderson RM, Funnell MM. Compliance and adherence are dysfunctional concepts in diabetes care. Diabetes Educ. 2000 Jul-Aug;26(4):597-604. doi: 10.1177/014572170002600405.

Reference Type: BACKGROUND

PMID: 11140071 (View on PubMed)

Other Identifiers

62323 (completed)

Identifier Type: -

Identifier Source: org_study_id