Service and Health Among Deployed Veterans (SHADE)

CSP #595 - Pulmonary Health and Deployment to Southwest Asia and Afghanistan

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pulmonary Function

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 Type: Observational
• Enrollment (Estimated): 6200

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System, San Diego, CA
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta VA Medical and Rehab Center, Decatur, GA
  • Massachusetts
    • West Roxbury, Massachusetts, United States, 02132
      • VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Health Care System, Minneapolis, MN
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center, Houston, TX
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current forced vital capacity (FVC)	An assessment of pulmonary function obtained through spirometry	Outcome measured at time of in-person study visit (Day 1)
Current FEV1/FVC ratio	An assessment of pulmonary function obtained through spirometry	Outcome measured at time of in-person study visit (Day 1)
Pharmaceutically-treated asthma	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.	Outcome measured at time of in-person study visit (Day 1)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: United States Department of Defense; Harvard University
• Investigators: Study Chair: Eric Garshick, MD, VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA; Study Chair: Paul D Blanc, MD MSPH, San Francisco VA Medical Center, San Francisco, CA; Study Chair: Vincent S. Fan, MD MPH, VA Puget Sound Health Care System Seattle Division, Seattle, WA; Study Chair: Susan P Proctor, DSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications and helpful links

Helpful Links

• Seattle Epidemiologic Research and Information Center
• VA Cooperative Studies Program

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimated): July 7, 2016

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Observational; Lung; Pulmonary; Epidemiologic; Military and environmental exposures; Interview or questionnaire; Deployment related; Enduring Freedom; Iraqi Freedom
• Other Study ID Numbers: 595 (Ct Surgery Network Research Group)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data may be shared dependent upon data safeguards and IRB approvals.
• IPD Sharing Time Frame: Data will be made available for sharing 1 year after the publication of the last manuscript addressing the primary aims of the study.
• IPD Sharing Access Criteria: The VA Cooperative Studies Program (CSP) has a program for sharing CSP study data: Integrated Veteran Epidemiologic Study Data Resource (INVESTD-R). The INVESTD-R website is where information is provided on CSP studies with data that can be shared for secondary analyses or to support new data collection from study members who consented to be recontacted. Data will be shared with qualifying investigators at bona fide research institutions.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No