Evaluation of Diabetes Self-Management Consultant Care
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|ClinicalTrials.gov Identifier: NCT00109720|
Recruitment Status : Completed
First Posted : May 3, 2005
Last Update Posted : January 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Behavioral: Diabetes Self-Management Consultant Behavioral: Enhanced Usual Care Control Group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||310 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Diabetes Self-Management Consultant Care|
|Study Start Date :||August 2002|
|Actual Study Completion Date :||July 2007|
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
Active Comparator: 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.
Behavioral: Enhanced Usual Care Control Group
Usual care plus results of metabolic assessments obtained during the study
- Blood glucose level [ Time Frame: two years ]
- Diabetes Related Quality of life [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109720
|United States, Michigan|
|University of Michigan, Department of Family Medicine Clinics|
|Ann Arbor, Michigan, United States, 48109|
|Detroit Health Department|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Robert Anderson, Ed. D.||Department of Medical Education, University of Michigan|