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Prospective Study of Veteran Health in Previously Deployed Soldiers

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.
ClinicalTrials.gov Identifier: NCT00285246
Recruitment Status : Completed
First Posted : February 1, 2006
Results First Posted : October 6, 2014
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Combat Disorders
Enrollment 838
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Period Title: Overall Study
Started 838
Completed 790 [1]
Not Completed 48
[1]
Number of participants who were eligible and completed at least one phase of data collection
Arm/Group Title All Participants
Hide Arm/Group Description Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Overall Number of Baseline Participants 838
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 838 participants
27.9  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 838 participants
Female
96
  11.5%
Male
742
  88.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 838 participants
White/Causasian 564
Hispanic/Latino 33
Black/African American/Non-Hispanic 72
Black/African American/Hispanic 1
Asian 12
Native Hawaiian or other Pacific Islander 10
American Indian or Alaskan Native 46
Unknown/Not Provided 100
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 838 participants
838
1.Primary Outcome
Title Non-Specific Physical Symptoms
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Not all of the 790 completers has complete data on the non-specific physical symptoms measure.
Arm/Group Title All Participants
Hide Arm/Group Description:
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Overall Number of Participants Analyzed 767
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phase 1 5.2  (3.9)
Phase 2 7.9  (4.9)
Phase 3 7.7  (5.1)
Phase 4 7.7  (5.4)
2.Primary Outcome
Title Physical Functional Status
Hide Description 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.
Time Frame pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Not all of the 790 completers has complete data on this physical functional status measure.
Arm/Group Title All Participants
Hide Arm/Group Description:
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Overall Number of Participants Analyzed 762
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Phase 1 55.5  (5.2)
Phase 2 53.7  (6.9)
Phase 3 52.8  (7.6)
Phase 4 51.5  (8.8)
3.Primary Outcome
Title Mental Functional Status
Hide Description 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.
Time Frame pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return
Hide Outcome Measure Data
Hide Analysis Population Description
Not all of the 790 completers has complete data on the mental functional status measure.
Arm/Group Title All Participants
Hide Arm/Group Description:
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Overall Number of Participants Analyzed 762
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phase 1 48.0  (9.1)
Phase 2 45.7  (10.7)
Phase 3 45.0  (11.5)
Phase 4 44.9  (12.4)
4.Primary Outcome
Title Health Care Utilization
Hide Description This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.
Time Frame pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Not all of the 790 completers has complete data on the healthcare utilization measure.
Arm/Group Title All Participants
Hide Arm/Group Description:
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
Overall Number of Participants Analyzed 752
Mean (Standard Deviation)
Unit of Measure: number of visits in prior 12 months
Phase 1 0.78  (0.87)
Phase 2 0.68  (0.81)
Phase 3 0.69  (0.74)
Phase 4 1.11  (0.97)
Time Frame Data were collected at all 4 time points (pre-deployment=Phase 1, immediate post-deployment=Phase 2, 3 months post-deployment=Phase 3, one year post-deployment=Phase 4). The entire duration was about 2 years given an average deployment of about one year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/838 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/838 (0.00%) 
The sample was comprised of only Army National Guard and Reserve military personnel, and therefore results may not generalize to the broader population of military personnel from other Service branches or components.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Karen S. Quigley, Ph.D., Research Physiologist
Organization: Edith Nourse Rogers Memorial VA Hospital
Phone: 781-687-2273
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00285246     History of Changes
Other Study ID Numbers: IIR 02-296
First Submitted: January 30, 2006
First Posted: February 1, 2006
Results First Submitted: August 28, 2014
Results First Posted: October 6, 2014
Last Update Posted: May 12, 2015