Clinical trial NCT02825654: Service and Health Among Deployed Veterans
Official title: CSP #595 - Pulmonary Health and Deployment to Southwest Asia and Afghanistan
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pulmonary Function
Keywords: Pulmonary
Lung
Military and environmental exposures
Epidemiologic
Observational
Interview or questionnaire
Deployment related
Enduring Freedom
Iraqi Freedom
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: United States Department of Defense
name: Harvard University
First posted: 2016-07-07
Enrollment: 6200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The sampling frame for the study is military personnel identified from Department of Defense (DoD) Defense Manpower Data Center (DMDC) records who meet the inclusion and exclusion criteria. From among those Veterans who meet study eligibility, the investigators will identify a sample of Veterans living in the catchment area of the participating VA medical centers for recruitment. The study is not open to volunteers; Veterans must be selected from the sampling frame to participate.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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 after October 1, 2001

Exclusion Criteria:

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

Primary outcomes:
measure: Current forced expiratory volume in 1 second (FEV1)
timeFrame: Outcome measured at time of in-person study visit (Day 1)
Secondary outcomes:
measure: Current forced vital capacity (FVC)
timeFrame: Outcome measured at time of in-person study visit (Day 1)
measure: Current FEV1/FVC ratio
timeFrame: Outcome measured at time of in-person study visit (Day 1)
measure: Pharmaceutically-treated asthma
timeFrame: Outcome measured at time of in-person study visit (Day 1)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: West Roxbury
country: United States
facility: VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
name: Eric Garshick, MD
role: STUDY_CHAIR
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Paul D Blanc, MD MSPH
role: STUDY_CHAIR
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Susan P Proctor, DSc
role: STUDY_CHAIR
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Vincent S. Fan, MD MPH
role: STUDY_CHAIR
References: