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Racial/Ethnic Differences in Trust/Mistrust and Its Effect on Diabetes Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00383110
First Posted: October 2, 2006
Last Update Posted: April 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
  1. Determine racial/ethnic differences in trust in physicians and mistrust of the health care system among veterans with Type 2 Diabetes.
  2. Determine the predictive power of trust in physicians and mistrust of the health care system on personal health practices and health outcomes in a prospective cohort of veterans with Type 2 Diabetes

Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Racial/Ethnic Differences in Trust/Mistrust and Its Effect on Diabetes Outcomes

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • General Trust in Physicians Scale (GTIPS) [ Time Frame: 12 months following enrollment ]
    The GTIPS is a valid and reliable 11-item measure of general trust in physicians in the domains of dependability, confidence, and confidentiality of information. All items are fashioned in a 5-point Likert format with a minimum score of 11 and maximum of 55. Higher scores indicate more trust in physicians.

  • Health Care System Distrust Scale [ Time Frame: 12 months after enrollment ]
    Health Care System Distrust Scale is a valid and reliable 10-item measure of distrust of the health care system, measuring honesty confidentiality and confidence. All questions are measured on a Likert scale, with scores ranging from a minimum of 10 to a maximum of 50. Higher scores indicate more distrust in the health care system.


Secondary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 12 months after enrollment ]
  • Systolic Blood Pressure [ Time Frame: 12-months after enrollment ]
  • Diastolic Blood Pressure [ Time Frame: 12-months after enrollment ]
  • LDL-cholesterol [ Time Frame: 12-months after enrollment ]

Enrollment: 300
Study Start Date: November 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Adults (age 18 or older) with type 2 diabetes.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
equal number of White and Black Americans over the age of 18 with Type II diabetes
Criteria

Inclusion Criteria:

  • Patients for this study will be recruited from the Ralph H. Johnson VAMC in Charleston, South Carolina.
  • American veterans aged 18 years and older with Type 2 Diabetes will be recruited.

Exclusion Criteria:

  • Children will not be included as this study pertains to type 2 diabetes, which is not a disease of children.
  • Non-English speaking patients are excluded to eliminate bias in the response to questionnaires because these questionnaires have only been validated in English speaking patients.
  • We decided to exclude cognitively impaired individuals because of the complexity of the survey instruments.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383110


Locations
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Leonard E. Egede, MD MS Ralph H. Johnson VA Medical Center, Charleston, SC
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00383110     History of Changes
Other Study ID Numbers: LIP 82-001
HR#11259 ( Other Identifier: MUSC/VA IRB )
First Submitted: September 28, 2006
First Posted: October 2, 2006
Results First Submitted: August 4, 2014
Results First Posted: September 17, 2014
Last Update Posted: April 28, 2015
Last Verified: June 2014

Keywords provided by VA Office of Research and Development:
Diabetes
Health Outcomes
Racial Preference
Clinical Trial
Ethnic Differences

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases