Service and Health Among Deployed Veterans

• Conditions: Pulmonary Function

• Registration Number: NCT02825654
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Study Start: 2018-03-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2026-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 6200

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current forced expiratory volume in 1 second (FEV1)	Outcome measured at time of in-person study visit (Day 1)	An assessment of pulmonary function obtained through spirometry

Secondary Outcome Measures

Name	Time	Method
Current forced vital capacity (FVC)	Outcome measured at time of in-person study visit (Day 1)	An assessment of pulmonary function obtained through spirometry
Current FEV1/FVC ratio	Outcome measured at time of in-person study visit (Day 1)	An assessment of pulmonary function obtained through spirometry
Pharmaceutically-treated asthma	Outcome measured at time of in-person study visit (Day 1)	Based on medication inventory, the investigators will classify medically-treated asthma therapy into mild, moderate, and severe based on the intensity of asthma therapy as suggested by the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2015.

Trial Locations

Locations (6)

VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA; 🇺🇸 West Roxbury, Massachusetts, United States

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States

Atlanta VA Medical and Rehab Center, Decatur, GA; 🇺🇸 Decatur, Georgia, United States

Michael E. DeBakey VA Medical Center, Houston, TX; 🇺🇸 Houston, Texas, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States