Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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