- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00285246
Prospective Study of Veteran Health in Previously Deployed Soldiers
Prospective Study of Functional Status in Veterans at Risk for Unexplained Illnesses
Background: Previous deployments like that to the Persian Gulf in 1991 produced veterans with post-deployment symptom-based health problems with no medical explanation. This was termed Gulf War illness or medically unexplained illness (MUI). If previous wars are any indication, some soldiers currently deployed to hostile areas also will return home with unexplained symptom-based illnesses. However, when this study began there was virtually no pre-war, prospective data on risk and resilience factors associated with MUI. This study is attempting to fill that gap.
Objectives: Our goals are to: (a) determine pre- and immediate post-deployment factors predicting later MUI and poor functional status, (b) improve previous methodological problems (e.g., selection bias, recall bias and lack of baseline controls) in studies of MUI, and (c) relate pre-deployment risk factors (e.g., personality, stressor reactivity) and resilience factors (e.g., coping style, social support) to post-deployment functional status.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Mississippi
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Jackson, Mississippi, United States, 39216
- G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
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New Jersey
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East Orange, New Jersey, United States, 07018
- East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, New Jersey (NJ) and Camp Shelby, Mississippi (MS)
Exclusion Criteria:
- There are some drug exclusions for anything that substantially affects cardiovascular function.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-Specific Physical Symptoms
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)
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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.
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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)
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Physical Functional Status
Time Frame: pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)
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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.
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pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)
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Mental Functional Status
Time Frame: pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return
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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.
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pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return
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Health Care Utilization
Time Frame: pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)
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This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.
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pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)
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Collaborators and Investigators
Investigators
- Principal Investigator: Karen S. Quigley, PhD, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Publications and helpful links
General Publications
- McAndrew LM, D'Andrea E, Lu SE, Abbi B, Yan GW, Engel C, Quigley KS. What pre-deployment and early post-deployment factors predict health function after combat deployment?: a prospective longitudinal study of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) soldiers. Health Qual Life Outcomes. 2013 Apr 30;11:73. doi: 10.1186/1477-7525-11-73.
- Yan GW, McAndrew L, D'Andrea EA, Lange G, Santos SL, Engel CC, Quigley KS. Self-reported stressors of National Guard women veterans before and after deployment: the relevance of interpersonal relationships. J Gen Intern Med. 2013 Jul;28 Suppl 2(Suppl 2):S549-55. doi: 10.1007/s11606-012-2247-6.
- Falvo MJ, Serrador JM, McAndrew LM, Chandler HK, Lu SE, Quigley KS. A retrospective cohort study of U.S. service members returning from Afghanistan and Iraq: is physical health worsening over time? BMC Public Health. 2012 Dec 28;12:1124. doi: 10.1186/1471-2458-12-1124.
- Quigley KS, McAndrew LM, Almeida L, D'Andrea EA, Engel CC, Hamtil H, Ackerman AJ. Prevalence of environmental and other military exposure concerns in Operation Enduring Freedom and Operation Iraqi Freedom veterans. J Occup Environ Med. 2012 Jun;54(6):659-64. doi: 10.1097/JOM.0b013e3182570506.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 02-296
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