NCT01749345

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

2.1 years

First QC Date

December 11, 2012

Last Update Submit

May 7, 2018

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • HbA1C

    Within 3 months prior to the assessment

  • Quality of life

    Within a month of completely the assessment

Secondary Outcomes (2)

  • Blood pressure

    Most recent to assessment date

  • Low density lipoprotein (LDL) Cholesterol

    Most recent to assessment date

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pimary care and internal medicine clinics

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Leonard E Egede, M.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 13, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

US(2)