Southeastern Diabetes Initiative Clinical Intervention (SEDI)

This study is currently recruiting participants.
Verified October 2013 by Duke University
Sponsor:
Collaborators:
Centers for Medicare and Medicaid Services
Bristol-Myers Squibb
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01965639
First received: October 16, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted

October 16, 2013
October 16, 2013
April 2013
January 2015   (final data collection date for primary outcome measure)
Mortality [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Rate of health services utilization [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    As measured by inpatient hospital admissions and emergency department visits
  • Change in Medication Adherence [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    As measured by the Morisky Medication Adherence Score
  • Change in HbA1c [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Change in blood lipids [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Measurements include total cholesterol, HDL, LDL, triglycerides
  • Change in blood glucose [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Incidence of micro- and macro-vascular complications [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Includes retinopathy, neuropathy, kidney disease, cardiovascular disease
  • Change in patient-reported outcomes [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys
Same as current
Not Provided
Not Provided
 
Southeastern Diabetes Initiative Clinical Intervention
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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Diabetes Mellitus, Type 2
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.
Experimental: High Risk group
Extension of Care
Intervention: Other: Extension of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
June 2015
January 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Ashley Dunham, PhD 704-250-5862 ashley.dunham@duke.edu
Contact: Brooke Heidenfelder, PhD 919-668-8355 brooke.heidenfelder@duke.edu
United States
 
NCT01965639
Pro00043463, 1C1CMS331018
No
Duke University
Duke University
  • Centers for Medicare and Medicaid Services
  • Bristol-Myers Squibb
Principal Investigator: Robert Califf, MD Duke Translational Medicine Institute
Principal Investigator: Bryan Batch, MD Duke University
Duke University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP