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| ID | Type | Description | Link |
|---|---|---|---|
| 1C1CMS331018 | Other Grant/Funding Number | Centers for Medicare and Medicaid Services |
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| Name | Class |
|---|---|
| Centers for Medicare and Medicaid Services | FED |
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of the Southeastern Diabetes Initiative Clinical Intervention is to augment existing standard of care in an effort to (1) improve population level diabetes management, health outcomes and quality of life for diagnosed and undiagnosed adults living with Type 2 Diabetes Mellitus, (2) reduce disparities in diabetes management, health outcomes and quality of life for adults living with Type 2 Diabetes Mellitus, and (3) reduce healthcare costs associated with Type 2 Diabetes Mellitus.
Clinical care will be delivered by a multidisciplinary team including (but not limited to) an physician, nurse practitioner, dietician, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker. Care will be delivered in community settings including home visits and community based clinics. With the exception of specific surveys (listed in the Study Intervention section) all data are being collected for the purpose of delivery of standard preventive care and clinical care. The population group will include patients diagnosed with Type 2 Diabetes Mellitus in four Southern United States counties, meeting certain inclusion criteria, and deemed "high risk" as determined by a set of standard criteria or a risk algorithm run on secondary data.
The investigators plan to characterize patients diagnosed or at risk for diabetes mellitus, and allow more detailed knowledge of their health than is provided by standard public health data. The investigators will use descriptive, parametric and non-parametric statistics to describe baseline characteristics (demographics and clinical measures of disease severity) of the sample and will compare responders and dropouts on independent and dependent variables, report any significant differences, and include this in the interpretation of results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk group | Experimental | Extension of Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extension of Care | Other | Clinical care will be delivered by a multidisciplinary team including (but not limited to) a physician, nurse practitioner, dietitian, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker in community settings including home visits and community based clinics. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of health services utilization | As measured by inpatient hospital admissions and emergency department visits | up to 24 months |
| Change in Medication Adherence | As measured by the Morisky Medication Adherence Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Califf, MD | Duke Translational Medicine Institute | Principal Investigator |
| Bryan Batch, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mississippi Public Health Institute | Madison | Mississippi | United States | |||
| Durham County Department of Public Health |
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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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| Baseline, 6, 12, 18, and 24 months |
| Change in HbA1c | Baseline, 6, 12, 18, and 24 months |
| Change in blood lipids | Measurements include total cholesterol, HDL, LDL, triglycerides | Baseline, 6, 12, 18, and 24 months |
| Change in blood glucose | Baseline, 6, 12, 18, and 24 months |
| Change in blood pressure | Baseline, 6, 12, 18, and 24 months |
| Incidence of micro- and macro-vascular complications | Includes retinopathy, neuropathy, kidney disease, cardiovascular disease | Up to 24 months |
| Change in patient-reported outcomes | Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys | Baseline, 6, 12, 18, and 24 months |
| Durham |
| North Carolina |
| United States |
| Cabarrus Health Alliance | Kannapolis | North Carolina | United States |
| Williamson Health and Wellness Center | Williamson | West Virginia | United States |
| D004700 | Endocrine System Diseases |