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Service and Health Among Deployed Veterans (SHADE)

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VA Office of Research and Development

Status

Invitation-only

Conditions

Pulmonary Function

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02825654
595 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to better understand the health, including lung health, of Veterans who deployed in support of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), or Operation New Dawn (OND) and other deployments following these Operations.

Full description

The aim of the study is to characterize the impact of deployment-related pollution exposures during the Post-9/11 Gulf War Era on current respiratory health using objectively ascertained and standardized physiologic and epidemiologic measures. The primary objective in support of this aim is to assess the association of cumulative exposure to PM2.5 during deployments to the U.S. bases and other locations in Central Asia (Afghanistan and Kyrgyzstan), Southwest Asia (Iraq, Kuwait, Qatar, and United Arab Emirates) and Africa (Djibouti) with current measures of pulmonary function. Secondary objectives in support of the aim will examine the association of cumulative exposure to PM2.5 during deployments with the clinical outcome of medically-treated asthma. The investigators will also explore the impact of deployment duration on both pulmonary function and asthma.

This study will execute 4 distinct efforts to meet the study objectives: (1) enroll a study cohort of up to 6,200 Veterans who live within the catchment area of 6 VA recruitment sites, conduct an in-person assessment of pulmonary function, and collect data on key covariates; (2) create a spatial-temporal exposure grid of environmental PM2.5 levels averaged per week per 1 square kilometer at locations where military personnel served; (3) link each individual's location and duration (spatial-temporal) history during deployed and non-deployed times with averaged PM exposures during each of these time periods; and (4) conduct association analyses to test hypotheses of deployment-related cumulative PM2.5 exposure and current respiratory health by combining exposure data with data collected from the cohort members and from their military records.

Enrollment

6,200 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Served during the Post-9/11 Gulf War Era in a service branch that had land-based deployments (Air Force, Army, and Marine Corps)
  • Deployed to Afghanistan, Kyrgyzstan, Iraq, Kuwait, Qatar, United Arab Emirates, or Djibouti between October 1, 2001 and August 31, 2021

Exclusion criteria

  • Active duty at the time of recruitment
  • Impaired decision making capacity
  • No English language proficiency
  • Prisoners

Trial design

6,200 participants in 1 patient group

Post-9/11 Gulf War Era Veterans
Description:
Military personnel who deployed to Central Asia, Southwest Asia, and Africa during the Post-9/11 Gulf War Era

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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