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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
Diabetes self management support is telephonic and will be provided by health navigators at a central call center
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual care | No Intervention | usual care includes diabetes self management education | |
| diabetes self management support | Active Comparator | diabetes self management support in addition to usual care, which includes diabetes self management education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diabetes self management support | Other | diabetes self management support is telephonic and provided by health investigators |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Sherr, MS, RD, CDE | American Association of Diabetes Educators | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Rio Community Health Center | Tucson | Arizona | 85701 | United States | ||
| Cross Trails Medical Center |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
| Cape Girardeau |
| Missouri |
| 63703 |
| United States |
| Triad Adult and Pediatric Medicine, Inc. | High Point | North Carolina | 27262 | United States |
| FamilyCare Health Center | Scott Depot | West Virginia | 25560 | United States |
| D004700 | Endocrine System Diseases |