NCT00109720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

First QC Date

May 2, 2005

Last Update Submit

January 14, 2010

Conditions

Type 2 Diabetes Mellitus

Keywords

DiabetesSelf ManagementType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Blood glucose level

    two years

Secondary Outcomes (1)

  • Diabetes Related Quality of life

    two years

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: 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

Interventions

Diabetes Self-Management ConsultantBEHAVIORAL

services of a Diabetes Self-Management Consultant

1
Enhanced Usual Care Control GroupBEHAVIORAL

Usual care plus results of metabolic assessments obtained during the study

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients under psychiatric care
  • Currently pregnant
  • Those who have not been diagnosed with type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan, Department of Family Medicine Clinics

Ann Arbor, Michigan, 48109, United States

Location

Detroit Health Department

Detroit, Michigan, 48202, United States

Location

Related Publications (6)

  • 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.

    PMID: 14687274BACKGROUND

  • 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.

    PMID: 12728638BACKGROUND

  • 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.

    PMID: 12854337BACKGROUND

  • 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.

    PMID: 12716841BACKGROUND

  • 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.

    PMID: 11985929BACKGROUND

  • 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.

    PMID: 11140071BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Robert Anderson, Ed. D.

    Department of Medical Education, University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 2, 2005

First Posted

May 3, 2005

Study Start

August 1, 2002

Study Completion

July 1, 2007

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

US(2)