NCT00383110

Brief Summary

  1. 1.Determine racial/ethnic differences in trust in physicians and mistrust of the health care system among veterans with Type 2 Diabetes.
  2. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

September 17, 2014

Completed
Last Updated

April 28, 2015

Status Verified

June 1, 2014

Enrollment Period

4.2 years

First QC Date

September 28, 2006

Results QC Date

August 4, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

DiabetesHealth OutcomesRacial PreferenceClinical TrialEthnic Differences

Outcome Measures

Primary Outcomes (2)

  • General Trust in Physicians Scale (GTIPS)

    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.

    12 months following enrollment

  • Health Care System Distrust Scale

    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.

    12 months after enrollment

Secondary Outcomes (4)

  • Hemoglobin A1c

    12 months after enrollment

  • Systolic Blood Pressure

    12-months after enrollment

  • Diastolic Blood Pressure

    12-months after enrollment

  • LDL-cholesterol

    12-months after enrollment

Study Arms (1)

Group 1

Adults (age 18 or older) with type 2 diabetes.

Eligibility Criteria

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

equal number of White and Black Americans over the age of 18 with Type II diabetes

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Leonard Egede, MD, MS
Organization
Ralph H. Johnson VAMC

Study Officials

  • Leonard E. Egede, MD MS

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

September 28, 2006

First Posted

October 2, 2006

Study Start

November 1, 2004

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

April 28, 2015

Results First Posted

September 17, 2014

Record last verified: 2014-06

Locations