Southeastern Diabetes Initiative Clinical Intervention (SEDI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: Extension of Care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Mortality [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 800
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Risk group
Extension of Care
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965639

Contacts
Contact: Ashley Dunham, PhD 704-250-5862 ashley.dunham@duke.edu
Contact: Brooke Heidenfelder, PhD 919-668-8355 brooke.heidenfelder@duke.edu

Locations
United States, Mississippi
Mississippi Public Health Institute Recruiting
Madison, Mississippi, United States
Principal Investigator: Ellen Jones, PhD, CHES         
United States, North Carolina
Durham County Department of Public Health Recruiting
Durham, North Carolina, United States
Principal Investigator: Bryan Batch, MD         
Cabarrus Health Alliance Recruiting
Kannapolis, North Carolina, United States
Principal Investigator: Russell Suda, MD         
United States, West Virginia
Williamson Health and Wellness Center Recruiting
Williamson, West Virginia, United States
Principal Investigator: Vicki Hatfield, MSN, APRN         
Sponsors and Collaborators
Duke University
Centers for Medicare and Medicaid Services
Bristol-Myers Squibb
Investigators
Principal Investigator: Robert Califf, MD Duke Translational Medicine Institute
Principal Investigator: Bryan Batch, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01965639     History of Changes
Other Study ID Numbers: Pro00043463, 1C1CMS331018
Study First Received: October 16, 2013
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Diabetes Mellitus Type 2
Standard of care
Quality of life
Disease management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014