Clinical trial NCT01965639: Southeastern Diabetes Initiative Clinical Intervention
Official title: A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus Type 2
Standard of care
Quality of life
Disease management
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
name: Bristol-Myers Squibb
First posted: 2013-10-18
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Mortality
timeFrame: Up to 24 months
Secondary outcomes:
measure: Rate of health services utilization
timeFrame: up to 24 months
measure: Change in Medication Adherence
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in HbA1c
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in blood lipids
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in blood glucose
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Change in blood pressure
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Incidence of micro- and macro-vascular complications
timeFrame: Up to 24 months
measure: Change in patient-reported outcomes
timeFrame: Baseline, 6, 12, 18, and 24 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: Mississippi Public Health Institute
state: Mississippi
city: Durham
country: United States
facility: Durham County Department of Public Health
state: North Carolina
city: Kannapolis
country: United States
facility: Cabarrus Health Alliance
state: North Carolina
city: Williamson
country: United States
facility: Williamson Health and Wellness Center
state: West Virginia
Study officials:
affiliation: Duke Translational Medicine Institute
name: Robert Califf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Bryan Batch, MD
role: PRINCIPAL_INVESTIGATOR
References: