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Evaluation of Diabetes Self-Management Consultant Care

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Self-Management Consultant
Enhanced Usual Care Control Group
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Self Management, Type 2 diabetes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan, Department of Family Medicine Clinics
  • Detroit Health Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Blood glucose level

Secondary Outcome Measures

Diabetes Related Quality of life

Full Information

First Posted
May 2, 2005
Last Updated
January 14, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Detroit Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT00109720
Brief Title
Evaluation of Diabetes Self-Management Consultant Care
Official Title
Evaluation of Diabetes Self-Management Consultant Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Detroit Department of Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes, Self Management, Type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients in the experimental group received the services of a Diabetes Self-Management Consultant (DSC)
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Self-Management Consultant
Intervention Description
services of a Diabetes Self-Management Consultant
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care Control Group
Intervention Description
Usual care plus results of metabolic assessments obtained during the study
Primary Outcome Measure Information:
Title
Blood glucose level
Time Frame
two years
Secondary Outcome Measure Information:
Title
Diabetes Related Quality of life
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Anderson, Ed. D.
Organizational Affiliation
Department of Medical Education, University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan, Department of Family Medicine Clinics
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Detroit Health Department
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14687274
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. doi: 10.1046/j.1525-1497.2003.21132.x.
Results Reference
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PubMed Identifier
12728638
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. doi: 10.1007/s11892-003-0036-7.
Results Reference
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PubMed Identifier
12854337
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. doi: 10.1177/014572170302900310. No abstract available.
Results Reference
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PubMed Identifier
12716841
Citation
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.
Results Reference
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PubMed Identifier
11985929
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. doi: 10.1016/s0749-3797(02)00431-2. No abstract available.
Results Reference
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PubMed Identifier
11140071
Citation
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.
Results Reference
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Evaluation of Diabetes Self-Management Consultant Care

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