Southeastern Diabetes Initiative Clinical Intervention

NCT ID: NCT01965639

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 648 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

High Risk group

Extension of Care

Group Type: EXPERIMENTAL

Extension of Care

Intervention Type: 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.

Interventions

Extension of Care

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults >=18yrs
• Diagnosis of Type 2 diabetes
• Reside in Durham County, NC, Cabarrus County, NC, Quitman County, MS or Mingo County, WV or the neighboring areas and receive the majority of their healthcare in the four listed counties.
• Have capacity to give consent (or have a surrogate legally authorized representative or caregiver provide consent on their behalf).
• Defined as high risk by the risk algorithm or their primary care clinician.
• Referral from the primary care clinician or patient's medical home if one has been designated.

Exclusion Criteria

• Lack capacity to make decisions and do not have a surrogate with authority to make health care decisions.
• Have a terminal illness with a life expectancy of 6 months or less
• Diagnosis of Type 1 diabetes or gestational diabetes
• Currently pregnant (confirmed via self-report and/or medical record)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Medicare and Medicaid Services

FED

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Califf, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Translational Medicine Institute

Bryan Batch, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Mississippi Public Health Institute

Madison, Mississippi, United States

Durham County Department of Public Health

Durham, North Carolina, United States

Cabarrus Health Alliance

Kannapolis, North Carolina, United States

Williamson Health and Wellness Center

Williamson, West Virginia, United States

Countries

United States

Other Identifiers

1C1CMS331018

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00043463

Identifier Type: -

Identifier Source: org_study_id