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

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ClinicalTrials.gov Identifier: NCT00383110
Recruitment Status : Completed
First Posted : October 2, 2006
Results First Posted : September 17, 2014
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
  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 or disease
Diabetes

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Racial/Ethnic Differences in Trust/Mistrust and Its Effect on Diabetes Outcomes
Study Start Date : November 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Group/Cohort
Group 1
Adults (age 18 or older) with type 2 diabetes.



Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Hemoglobin A1c [ Time Frame: 12 months after enrollment ]
  2. Systolic Blood Pressure [ Time Frame: 12-months after enrollment ]
  3. Diastolic Blood Pressure [ Time Frame: 12-months after enrollment ]
  4. LDL-cholesterol [ Time Frame: 12-months after enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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 Posted: October 2, 2006    Key Record Dates
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