Evaluation of Diabetes Self-Management Consultant Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Diabetes Self-Management Consultant Care

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Diabetes Self-Management Consultant
* Behavioral: Enhanced Usual Care Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients in the experimental group received the services of a Diabetes Self-Management Consultant (DSC) | Behavioral: Diabetes Self-Management Consultant<br>* services of a Diabetes Self-Management Consultant<br>|
| Active Comparator: 2<br>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<br>* Usual care plus results of metabolic assessments obtained during the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose level |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Related Quality of life |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Self Management, Type 2 diabetes