Trial Outcomes & Findings for Racial/Ethnic Differences in Trust/Mistrust and Its Effect on Diabetes Outcomes (NCT NCT00383110)
NCT ID: NCT00383110
Last Updated: 2015-04-28
Results Overview
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.
COMPLETED
300 participants
12 months following enrollment
2015-04-28
Participant Flow
Patients were recruited from the Charleston VAMC. Veterans with Type 2 Diabetes identified through the VA electronic medical resources system (CPRS) were consented and enrolled between November 2004 and February 2006.
Participant milestones
| Measure |
White American Veterans
White American adult Veterans (age 18 or older) with type 2 diabetes
|
Black American Veterans
Black American adult Veterans (age 18 or older) with type 2 diabetes
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
150
|
150
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Racial/Ethnic Differences in Trust/Mistrust and Its Effect on Diabetes Outcomes
Baseline characteristics by cohort
| Measure |
White American Veterans
n=150 Participants
White American adult Veterans (age 18 or older) with type 2 diabetes
|
Black American Veterans
n=150 Participants
Black American adult Veterans (age 18 or older) with type 2 diabetes
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.11 years
STANDARD_DEVIATION 9.49 • n=99 Participants
|
63.78 years
STANDARD_DEVIATION 10.84 • n=107 Participants
|
65.93 years
STANDARD_DEVIATION 10.41 • n=206 Participants
|
|
Gender
Female
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Gender
Male
|
143 participants
n=99 Participants
|
142 participants
n=107 Participants
|
285 participants
n=206 Participants
|
|
Marital Status
Married
|
101 participants
n=99 Participants
|
84 participants
n=107 Participants
|
185 participants
n=206 Participants
|
|
Marital Status
Not Married
|
44 participants
n=99 Participants
|
64 participants
n=107 Participants
|
108 participants
n=206 Participants
|
|
Diabetes Duration
|
11.6 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
10.0 years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
10.8 years
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
Education
|
13.4 years
STANDARD_DEVIATION 2.9 • n=99 Participants
|
12.3 years
STANDARD_DEVIATION 3.2 • n=107 Participants
|
12.8 years
STANDARD_DEVIATION 3.1 • n=206 Participants
|
|
Work Status
Working
|
39 participants
n=99 Participants
|
34 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Work Status
Retired
|
71 participants
n=99 Participants
|
50 participants
n=107 Participants
|
121 participants
n=206 Participants
|
|
Work Status
Disabled
|
29 participants
n=99 Participants
|
48 participants
n=107 Participants
|
77 participants
n=206 Participants
|
|
Work Status
Other
|
4 participants
n=99 Participants
|
7 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Income
< $20,000
|
46 participants
n=99 Participants
|
73 participants
n=107 Participants
|
119 participants
n=206 Participants
|
|
Income
$20,000-$34,999
|
49 participants
n=99 Participants
|
32 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
Income
$35,000-$49,999
|
20 participants
n=99 Participants
|
18 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Income
$50,000-$74,999
|
14 participants
n=99 Participants
|
13 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Income
> $75,000
|
12 participants
n=99 Participants
|
1 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Comorbidity Index
|
1.8 units on a scale
STANDARD_DEVIATION 1.3 • n=99 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 2.4 • n=107 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 1.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 months following enrollmentPopulation: Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.
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.
Outcome measures
| Measure |
White American Veterans
n=144 Participants
White American adult Veterans (age 18 or older) with type 2 diabetes
|
Black American Veterans
n=145 Participants
Black American adult Veterans (age 18 or older) with type 2 diabetes
|
|---|---|---|
|
General Trust in Physicians Scale (GTIPS)
|
39.0 units on a scale
Standard Deviation 9.7
|
39.5 units on a scale
Standard Deviation 7.6
|
PRIMARY outcome
Timeframe: 12 months after enrollmentPopulation: Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.
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.
Outcome measures
| Measure |
White American Veterans
n=143 Participants
White American adult Veterans (age 18 or older) with type 2 diabetes
|
Black American Veterans
n=144 Participants
Black American adult Veterans (age 18 or older) with type 2 diabetes
|
|---|---|---|
|
Health Care System Distrust Scale
|
26.6 units on a scale
Standard Deviation 7.4
|
26.3 units on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 12 months after enrollmentPopulation: Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.
Outcome measures
| Measure |
White American Veterans
n=141 Participants
White American adult Veterans (age 18 or older) with type 2 diabetes
|
Black American Veterans
n=146 Participants
Black American adult Veterans (age 18 or older) with type 2 diabetes
|
|---|---|---|
|
Hemoglobin A1c
|
6.8 % HbA1c
Standard Deviation 1.2
|
7.1 % HbA1c
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 12-months after enrollmentPopulation: Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.
Outcome measures
| Measure |
White American Veterans
n=141 Participants
White American adult Veterans (age 18 or older) with type 2 diabetes
|
Black American Veterans
n=146 Participants
Black American adult Veterans (age 18 or older) with type 2 diabetes
|
|---|---|---|
|
Systolic Blood Pressure
|
131.9 mmHg
Standard Deviation 14.6
|
135.7 mmHg
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 12-months after enrollmentPopulation: Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.
Outcome measures
| Measure |
White American Veterans
n=141 Participants
White American adult Veterans (age 18 or older) with type 2 diabetes
|
Black American Veterans
n=146 Participants
Black American adult Veterans (age 18 or older) with type 2 diabetes
|
|---|---|---|
|
Diastolic Blood Pressure
|
71.1 mmHg
Standard Deviation 8.9
|
75.9 mmHg
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: 12-months after enrollmentPopulation: Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.
Outcome measures
| Measure |
White American Veterans
n=138 Participants
White American adult Veterans (age 18 or older) with type 2 diabetes
|
Black American Veterans
n=146 Participants
Black American adult Veterans (age 18 or older) with type 2 diabetes
|
|---|---|---|
|
LDL-cholesterol
|
86.4 mg/dL
Standard Deviation 22.5
|
101.2 mg/dL
Standard Deviation 27.5
|
Adverse Events
White American Veterans
Black American Veterans
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place