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Completed

NCT Number: NCT01965639

Southeastern Diabetes Initiative Clinical Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mississippi Public Health Institute, Madison, Mississippi, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Extension of Care

Other

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 outcomes

  1. Mortality

    Time frame: Up to 24 months

Secondary outcomes

  1. Rate of health services utilization

    Time frame: up to 24 months

    As measured by inpatient hospital admissions and emergency department visits

  2. Change in Medication Adherence

    Time frame: Baseline, 6, 12, 18, and 24 months

    As measured by the Morisky Medication Adherence Score

  3. Change in HbA1c

    Time frame: Baseline, 6, 12, 18, and 24 months

  4. Change in blood lipids

    Time frame: Baseline, 6, 12, 18, and 24 months

    Measurements include total cholesterol, HDL, LDL, triglycerides

  5. Change in blood glucose

    Time frame: Baseline, 6, 12, 18, and 24 months

  6. Change in blood pressure

    Time frame: Baseline, 6, 12, 18, and 24 months

  7. Incidence of micro- and macro-vascular complications

    Time frame: Up to 24 months

    Includes retinopathy, neuropathy, kidney disease, cardiovascular disease

  8. Change in patient-reported outcomes

    Time frame: Baseline, 6, 12, 18, and 24 months

    Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Bristol-Myers Squibb
  • Centers for Medicare and Medicaid Services

Registry information

Official study title

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

Acronym: SEDI

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 18, 2013
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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