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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 : February 28, 2022
Sponsor:
Collaborators:
United States Department of Defense
Harvard University
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date June 21, 2016
First Posted Date July 7, 2016
Last Update Posted Date February 28, 2022
Actual Study Start Date March 8, 2018
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2016)
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
Original Primary Outcome Measures
 (submitted: July 1, 2016)
Current forced expiratory volume in 1 second (FEV1) [ Time Frame: Outcome measured at time of in-person study visit ]
An assessment of pulmonary function obtained through spirometry
Change History
Current Secondary Outcome Measures
 (submitted: December 8, 2016)
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures
 (submitted: July 1, 2016)
  • Current forced vital capacity (FVC) [ Time Frame: Outcome measured at time of in-person study visit ]
    An assessment of pulmonary function obtained through spirometry
  • Current FEV1/FVC ratio [ Time Frame: Outcome measured at time of in-person study visit ]
    An assessment of pulmonary function obtained through spirometry
  • Pharmaceutically-treated asthma [ Time Frame: Outcome measured at time of in-person study visit ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Service and Health Among Deployed Veterans
Official Title CSP #595 - Pulmonary Health and Deployment to Southwest Asia and Afghanistan
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 50 Years
Biospecimen Not Provided
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.
Condition Pulmonary Function
Intervention Not Provided
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 1, 2016)
6200
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2025
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02825654
Other Study ID Numbers 595
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
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
Current Responsible Party VA Office of Research and Development
Original Responsible Party Same as current
Current Study Sponsor VA Office of Research and Development
Original Study Sponsor Same as current
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: 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
PRS Account VA Office of Research and Development
Verification Date February 2022