Social Determinants of Health in Diabetes Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Medical University of South Carolina
Sponsor:
Collaborators:
Ralph H. Johnson VA Medical Center
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01749345
First received: December 11, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Social Determinants of Health as Explanatory Factors for Ethnic Disparities in Diabetes Outcomes

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • HbA1C [ Time Frame: Within 3 months prior to the assessment ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Within a month of completely the assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Most recent to assessment date ] [ Designated as safety issue: No ]
  • Low density lipoprotein (LDL) Cholesterol [ Time Frame: Most recent to assessment date ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: July 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pimary care and internal medicine clinics

Criteria

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
  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: NCT01749345

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Brittany Smalls, MHSA    843-876-0698    smallsbr@musc.edu   
Contact: Joni Strom, MD    843-792-0906    stromjl@musc.edu   
Principal Investigator: Leonard E Egede, MD, MS         
Ralph H. Johnson VA Medical Center Recruiting
Charleston, South Carolina, United States, 29401
Contact: Rebekah Walker, MS    843-789-7587    rebekah.walker@va.gov   
Contact: Lois Idleman, MSN    843-789-6624    lois.idleman@va.gov   
Principal Investigator: Leonard E. Egede, MD, MS         
Sponsors and Collaborators
Medical University of South Carolina
Ralph H. Johnson VA Medical Center
Investigators
Principal Investigator: Leonard E Egede, M.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01749345     History of Changes
Other Study ID Numbers: 17676, 1K24DK093699-01
Study First Received: December 11, 2012
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

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 28, 2014