Prospective Study of Veteran Health in Previously Deployed Soldiers
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|ClinicalTrials.gov Identifier: NCT00285246|
Recruitment Status : Completed
First Posted : February 1, 2006
Results First Posted : October 6, 2014
Last Update Posted : May 12, 2015
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||838 participants|
|Official Title:||Prospective Study of Functional Status in Veterans at Risk for Unexplained Illnesses|
|Study Start Date :||December 2005|
|Primary Completion Date :||February 2011|
|Study Completion Date :||February 2011|
Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
- 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) ]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.
- 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) ]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.
- Mental Functional Status [ Time Frame: pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return ]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.
- 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) ]This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285246
|United States, Mississippi|
|G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS|
|Jackson, Mississippi, United States, 39216|
|United States, New Jersey|
|East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ|
|East Orange, New Jersey, United States, 07018|
|Principal Investigator:||Karen S. Quigley, PhD||East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ|