Southeastern Diabetes Initiative Clinical Intervention

Diabetes Mellitus, Type 2 Clinical Trial

— SEDI  

Official title:

A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965639
• Other study ID #: Pro00043463
• Secondary ID: 1C1CMS331018
• Status: Completed
• Phase: N/A
• First received: October 16, 2013
• Last updated: June 16, 2016
• Start date: April 2013
• Est. completion date: June 2016

Study information

• Verified date: April 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 648
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Durham County Department of Public Health	Durham	North Carolina
United States	Cabarrus Health Alliance	Kannapolis	North Carolina
United States	Mississippi Public Health Institute	Madison	Mississippi
United States	Williamson Health and Wellness Center	Williamson	West Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Bristol-Myers Squibb, Centers for Medicare and Medicaid Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		Up to 24 months	No
Secondary	Rate of health services utilization	As measured by inpatient hospital admissions and emergency department visits	up to 24 months	No
Secondary	Change in Medication Adherence	As measured by the Morisky Medication Adherence Score	Baseline, 6, 12, 18, and 24 months	No
Secondary	Change in HbA1c		Baseline, 6, 12, 18, and 24 months	No
Secondary	Change in blood lipids	Measurements include total cholesterol, HDL, LDL, triglycerides	Baseline, 6, 12, 18, and 24 months	No
Secondary	Change in blood glucose		Baseline, 6, 12, 18, and 24 months	No
Secondary	Change in blood pressure		Baseline, 6, 12, 18, and 24 months	No
Secondary	Incidence of micro- and macro-vascular complications	Includes retinopathy, neuropathy, kidney disease, cardiovascular disease	Up to 24 months	No
Secondary	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	No