Trial Outcomes & Findings for Prospective Study of Veteran Health in Previously Deployed Soldiers (NCT NCT00285246)
NCT ID: NCT00285246
Last Updated: 2015-05-12
Results Overview
Severity of non-specific physical symptoms from the 15 item Patient Health Questionnaire-15 (Kroenke, Spitzer \& Williams, 2002). Scale score range is 0-30. Higher scores indicate greater non-specific physical symptom severity. This scale does not contain subscales.
COMPLETED
838 participants
pre-deployment (Phase 1), immediately post-deployment (Phase 2), 3 months post-return from deployment (Phase 3), 1 year post-return from deployment (Phase 4)
2015-05-12
Participant Flow
Participant milestones
| Measure |
All Participants
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
|
|---|---|
|
Overall Study
STARTED
|
838
|
|
Overall Study
COMPLETED
|
790
|
|
Overall Study
NOT COMPLETED
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Study of Veteran Health in Previously Deployed Soldiers
Baseline characteristics by cohort
| Measure |
All Participants
n=838 Participants
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
|
|---|---|
|
Age, Continuous
|
27.9 years
STANDARD_DEVIATION 8.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
742 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White/Causasian
|
564 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
33 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Black/African American/Non-Hispanic
|
72 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Black/African American/Hispanic
|
1 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
10 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
46 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Provided
|
100 participants
n=39 Participants
|
|
Region of Enrollment
United States
|
838 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: pre-deployment (Phase 1), immediately post-deployment (Phase 2), 3 months post-return from deployment (Phase 3), 1 year post-return from deployment (Phase 4)Population: Not all of the 790 completers has complete data on the non-specific physical symptoms measure.
Severity of non-specific physical symptoms from the 15 item Patient Health Questionnaire-15 (Kroenke, Spitzer \& Williams, 2002). Scale score range is 0-30. Higher scores indicate greater non-specific physical symptom severity. This scale does not contain subscales.
Outcome measures
| Measure |
All Participants
n=767 Participants
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
|
|---|---|
|
Non-Specific Physical Symptoms
Phase 1
|
5.2 units on a scale
Standard Deviation 3.9
|
|
Non-Specific Physical Symptoms
Phase 2
|
7.9 units on a scale
Standard Deviation 4.9
|
|
Non-Specific Physical Symptoms
Phase 3
|
7.7 units on a scale
Standard Deviation 5.1
|
|
Non-Specific Physical Symptoms
Phase 4
|
7.7 units on a scale
Standard Deviation 5.4
|
PRIMARY outcome
Timeframe: pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)Population: Not all of the 790 completers has complete data on this physical functional status measure.
Physical Component Summary Score (PCS) from the Veterans RAND (VR) 36 measure (Kazis, 2000). Composite scores are normed to a mean of 50 and a SD of 10. Scores can range from 0-100. Higher scores indicate better physical function.
Outcome measures
| Measure |
All Participants
n=762 Participants
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
|
|---|---|
|
Physical Functional Status
Phase 1
|
55.5 Units on a scale
Standard Deviation 5.2
|
|
Physical Functional Status
Phase 2
|
53.7 Units on a scale
Standard Deviation 6.9
|
|
Physical Functional Status
Phase 3
|
52.8 Units on a scale
Standard Deviation 7.6
|
|
Physical Functional Status
Phase 4
|
51.5 Units on a scale
Standard Deviation 8.8
|
PRIMARY outcome
Timeframe: pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-returnPopulation: Not all of the 790 completers has complete data on the mental functional status measure.
Mental Component Summary Score (MCS) from the Veterans-RAND (VR) 36 (Kazis, 2000). MCS is a composite score with a mean of 50 and a standard deviation of 10. Scale scores range from 0-100 with higher scores reflecting better mental function.
Outcome measures
| Measure |
All Participants
n=762 Participants
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
|
|---|---|
|
Mental Functional Status
Phase 1
|
48.0 units on a scale
Standard Deviation 9.1
|
|
Mental Functional Status
Phase 2
|
45.7 units on a scale
Standard Deviation 10.7
|
|
Mental Functional Status
Phase 3
|
45.0 units on a scale
Standard Deviation 11.5
|
|
Mental Functional Status
Phase 4
|
44.9 units on a scale
Standard Deviation 12.4
|
PRIMARY outcome
Timeframe: pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)Population: Not all of the 790 completers has complete data on the healthcare utilization measure.
This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.
Outcome measures
| Measure |
All Participants
n=752 Participants
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
|
|---|---|
|
Health Care Utilization
Phase 1
|
0.78 number of visits in prior 12 months
Standard Deviation 0.87
|
|
Health Care Utilization
Phase 2
|
0.68 number of visits in prior 12 months
Standard Deviation 0.81
|
|
Health Care Utilization
Phase 3
|
0.69 number of visits in prior 12 months
Standard Deviation 0.74
|
|
Health Care Utilization
Phase 4
|
1.11 number of visits in prior 12 months
Standard Deviation 0.97
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Karen S. Quigley, Ph.D., Research Physiologist
Edith Nourse Rogers Memorial VA Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place