Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285246
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2006-01-30
Brief Title:
Prospective Study of Veteran Health in Previously Deployed Soldiers
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Prospective Study of Functional Status in Veterans at Risk for Unexplained Illnesses
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eg selection bias recall bias and lack of baseline controls in studies of MUI and c relate pre-deployment risk factors eg personality stressor reactivity and resilience factors eg coping style social support to post-deployment functional status
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 eg selection bias recall bias and lack of baseline controls in studies of MUI and c relate pre-deployment risk factors eg personality stressor reactivity and resilience factors eg coping style social support to post-deployment functional status
Detailed Description:
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 was virtually no pre-war prospective data on risk and resilience factors associated with MUI before 2001 This study will attempt 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 eg selection bias recall bias and lack of baseline controls in studies of MUI and c relate pre-deployment risk factors eg personality stressor reactivity and resilience factors eg coping style social support to post-deployment functional status Methods This study uses a prospective longitudinal observational design to assess risk and resilience factors for post-war MUI in Reserve and National Guard enlisted personnel A stratified random sample of more than 700 subjects will be drawn from those undergoing pre- and post-mobilization readiness processing at Fort Dix NJ and Camp Shelby MS Personnel will be tested pre-mobilization Phase 1 immediately after mobilization Phase 2 and at 3 months and 1 year post-deployment Phases 3 4 Predictor variables include personality social support coping style non-specific symptoms sympathetic cardiac stress reactivity and cortisol stress reactivity Control variables include prior traumatic events current distress PTSD symptoms socially desirable responding body mass index deployment experiences environmental exposures and demographics eg age gender Outcome variables include functional status healthcare utilization and MUI status using CDC criteria for chronic multisymptom illness developed after the first Gulf War Status Publications and presentations are being prepared Impact The larger prospective study with soldiers will help us to identify pre- and early post-deployment risk and resilience factors important in MUI functional status and healthcare utilization There is an urgent need for both pre- and post-deployment predictors of later MUI uncontaminated by recall bias and the selection bias of studying only treatment-seekers If we are to understand how to best treat veterans presenting with unexplained symptoms then we need to know which pre-war factors are most useful in predicting who is most likely to be resilient and who is most likely to be at risk for later unexplained illness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None