Social Determinants of Health in Diabetes Outcomes

May 7, 2018 updated by: Medical University of South Carolina

Social Determinants of Health as Explanatory Factors for Ethnic Disparities in Diabetes Outcomes

This is a cross-sectional study of six hundred adults with type 2 diabetes, (300 White and 300 African-American) who will be recruited from two primary care sites to determine how social determinants of health impact diabetes outcomes. The first aim is to investigate the role of psychosocial factors and SES on diabetes care processes and outcomes. The second aim is to investigate the influence of community and neighborhood characteristics on diabetes care processes and outcomes. Finally, we will examine the contribution of social determinants of health to ethnic differences in diabetes care processes and outcomes. Clinical and metabolic measures will be abstracted from the electronic medical records. Outcome variables include hemoglobin A1c, blood pressure, LDL-Cholesterol and quality of life.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401
        • Ralph H. Johnson VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pimary care and internal medicine clinics

Description

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes
  • Able to communicate in English

Exclusion Criteria:

  • Mental confusion on interview suggesting significant dementia
  • Alcohol or drug abuse/dependency
  • Active psychosis or acute mental disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1C
Time Frame: Within 3 months prior to the assessment
Within 3 months prior to the assessment
Quality of life
Time Frame: Within a month of completely the assessment
Within a month of completely the assessment

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: Most recent to assessment date
Most recent to assessment date
Low density lipoprotein (LDL) Cholesterol
Time Frame: Most recent to assessment date
Most recent to assessment date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ralph H. Johnson VA Medical Center

Investigators

  • Principal Investigator: Leonard E Egede, M.D., Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 13, 2012

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17676
  • 1K24DK093699-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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