Southeastern Diabetes Initiative Clinical Intervention (SEDI)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extension of Care
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus Type 2, Standard of care, Quality of life, Disease management
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)
Sites / Locations
- Mississippi Public Health Institute
- Durham County Department of Public Health
- Cabarrus Health Alliance
- Williamson Health and Wellness Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High Risk group
Arm Description
Extension of Care
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Rate of health services utilization
As measured by inpatient hospital admissions and emergency department visits
Change in Medication Adherence
As measured by the Morisky Medication Adherence Score
Change in HbA1c
Change in blood lipids
Measurements include total cholesterol, HDL, LDL, triglycerides
Change in blood glucose
Change in blood pressure
Incidence of micro- and macro-vascular complications
Includes retinopathy, neuropathy, kidney disease, cardiovascular disease
Change in patient-reported outcomes
Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys
Full Information
NCT ID
NCT01965639
First Posted
October 16, 2013
Last Updated
June 16, 2016
Sponsor
Duke University
Collaborators
Centers for Medicare and Medicaid Services, Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01965639
Brief Title
Southeastern Diabetes Initiative Clinical Intervention
Acronym
SEDI
Official Title
A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Centers for Medicare and Medicaid Services, Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus Type 2, Standard of care, Quality of life, Disease management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
648 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Risk group
Arm Type
Experimental
Arm Description
Extension of Care
Intervention Type
Other
Intervention Name(s)
Extension of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Rate of health services utilization
Description
As measured by inpatient hospital admissions and emergency department visits
Time Frame
up to 24 months
Title
Change in Medication Adherence
Description
As measured by the Morisky Medication Adherence Score
Time Frame
Baseline, 6, 12, 18, and 24 months
Title
Change in HbA1c
Time Frame
Baseline, 6, 12, 18, and 24 months
Title
Change in blood lipids
Description
Measurements include total cholesterol, HDL, LDL, triglycerides
Time Frame
Baseline, 6, 12, 18, and 24 months
Title
Change in blood glucose
Time Frame
Baseline, 6, 12, 18, and 24 months
Title
Change in blood pressure
Time Frame
Baseline, 6, 12, 18, and 24 months
Title
Incidence of micro- and macro-vascular complications
Description
Includes retinopathy, neuropathy, kidney disease, cardiovascular disease
Time Frame
Up to 24 months
Title
Change in patient-reported outcomes
Description
Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys
Time Frame
Baseline, 6, 12, 18, and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Califf, MD
Organizational Affiliation
Duke Translational Medicine Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bryan Batch, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mississippi Public Health Institute
City
Madison
State/Province
Mississippi
Country
United States
Facility Name
Durham County Department of Public Health
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Cabarrus Health Alliance
City
Kannapolis
State/Province
North Carolina
Country
United States
Facility Name
Williamson Health and Wellness Center
City
Williamson
State/Province
West Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Southeastern Diabetes Initiative Clinical Intervention
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