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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK065294 | U.S. NIH Grant/Contract | View source | |
| R03DK081726 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The proposed research will test a new comprehensive disease management intervention with adolescents who have type 2 diabetes using a randomized controlled trial (RCT). Adolescents subjects with a history of Type 2 Diabetes and a parent caregiver will be consented, enrolled, and randomly assigned to either an 6-month intervention (N=44) or a "usual care" comparison (N=44). Recruitment will take place within the Vanderbilt Eskind Pediatric Diabetes Clinic. The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. Outcomes include self-reported self-management behaviors (exercise, diet, medication adherence, etc.), blood pressure, weight/BMI, and glycated hemoglobin (A1C).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (Usual Care) | Active Comparator | Patients will continue to review usual care in the diabetes clinic. Patients will receive monthly phone calls as an active control condition. |
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| Intervention | Experimental | The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive intervention (disease management program) | Behavioral | The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. |
| Measure | Description | Time Frame |
|---|---|---|
| A1C | 0,3,6 months | |
| Lipids | 0,3,6 months |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | 0,3,6 months | |
| self-care behaviors | 0,3,6 months |
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Inclusion Criteria:
Patients with a diagnosis of T2DM will be included if they are:
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
Parent Inclusion criteria:
Parent Exclusion criteria:
Patients will be excluded if they meet any of the following:
Joint Inclusion criteria:
Both the primary caregiver (parent) and adolescent must agree to participate in the research.
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| Name | Affiliation | Role |
|---|---|---|
| Russell L Rothman, MD MPP | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Univ Medical Center | Nashville | Tennessee | 37232 | United States |
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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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| Usual Care | Behavioral | Will receive usual care and monthly phone calls as an active control. |
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| D004700 | Endocrine System Diseases |