Social Determinants of Health in Diabetes Outcomes
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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 |
- 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 ]
- 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 |
Pimary care and internal medicine clinics
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| 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 | |
| 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 May 22, 2013