Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support

Study Overview
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Brief Summary
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Improving diabetes social support is associated with health improvement benefits. This study is a prospective randomized controlled trial comparing the effects of telephone-based diabetes self-management support (DSMS) compared with usual care, which includes diabetes self-management education (DSME), during a 1-year period. It will determine whether this specific model for providing on-going support to people with diabetes will better enable them to maintain the engagement in self-care behaviors, clinical improvements and diabetes-specific knowledge gained during the course of diabetes self-management education.

Detailed Description
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Diabetes self management support is telephonic and will be provided by health navigators at a central call center

Official Title
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Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Other: diabetes self management support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English or Spanish speaking Diagnosis of type 2 diabetes mellitus HbA1c > 8 Have not completed a diabetes self management education program in the past year Exclusion Criteria: Current engagement in cancer treatment Diagnosis of end-stage renal disease Pregnant Receiving immunosuppressant therapy following transplant Diagnosis of serious mental illness Undergoing systemic treatment with prednisone

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care<br>usual care includes diabetes self management education | |
| Active Comparator: diabetes self management support<br>diabetes self management support in addition to usual care, which includes diabetes self management education | Other: diabetes self management support<br>* diabetes self management support is telephonic and provided by health investigators<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline HbA1c at 3, 9, 15, and 27 months | HbA1c assessment | 0, 3, 9, 15, and 27 months | 
| Change from baseline blood pressure at 3, 9, 15, and 27 months | blood pressure assessments | 0, 3, 9, 15, and 27 months | 
| Change from baseline cholesterol at 3, 9, 15, and 27 months | cholesterol assessments | 0, 3, 9, 15, and 27 months | 
| Change from baseline BMI at 3, 9, 15, and 27 months | body mass index (BMI) assessments | 0, 3, 9, 15, and 27 months | 
| Change from baseline weight at 3, 9, 15, and 27 months | weight assessments | 0, 3, 9, 15, and 27 months | 
| Change from baseline fasting glucose at 3, 9, 15, and 27 months | fasting glucose assessments | 0, 3, 9, 15, and 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline patient credential at 3, 9, 15, and 27 months | Patient Credential for Diabetes Patients developed by American Pharmacists Association Foundation (APhAF) | 0, 3, 9, 15, and 27 months | 
| Change from baseline depression at 3, 9, 15, and 27 months | Patient Health Questionnaire 2 Question Screening (PHQ-2) | 0, 3, 9, 15, and 27 months | 
| Change from baseline food security at 3, 9, 15, and 27 months | Food Security Screening Questionnaire | 0, 3, 9, 15, and 27 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes self management education, diabetes self management support, type 2 diabetes