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Service and Health Among Deployed Veterans (SHADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02825654
Recruitment Status : Enrolling by invitation
First Posted : July 7, 2016
Last Update Posted : January 26, 2023
Sponsor:
Collaborators:
United States Department of Defense
Harvard University
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 50 Years
Official Title: CSP #595 - Pulmonary Health and Deployment to Southwest Asia and Afghanistan
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : June 30, 2026
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Current forced expiratory volume in 1 second (FEV1) [ Time Frame: Outcome measured at time of in-person study visit (Day 1) ]
    An assessment of pulmonary function obtained through spirometry


Secondary Outcome Measures :
  1. Current forced vital capacity (FVC) [ Time Frame: Outcome measured at time of in-person study visit (Day 1) ]
    An assessment of pulmonary function obtained through spirometry

  2. Current FEV1/FVC ratio [ Time Frame: Outcome measured at time of in-person study visit (Day 1) ]
    An assessment of pulmonary function obtained through spirometry

  3. Pharmaceutically-treated asthma [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825654


Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, Massachusetts
VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
West Roxbury, Massachusetts, United States, 02132
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
United States Department of Defense
Harvard University
Investigators
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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: Susan P Proctor, DSc VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study Chair: Vincent S. Fan, MD MPH VA Puget Sound Health Care System Seattle Division, Seattle, WA
More Information
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Additional Information:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02825654    
Other Study ID Numbers: 595
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data may be shared dependent upon data safeguards and IRB approvals.
Supporting Materials: Informed Consent Form (ICF)
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.
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.
URL: https://www.vacsp.research.va.gov/CSPEC/Studies/INVESTD-R/Main.asp

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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
Keywords provided by VA Office of Research and Development:
Pulmonary
Lung
Military and environmental exposures
Epidemiologic
Observational
 Interview or questionnaire
Deployment related
Enduring Freedom
Iraqi Freedom