IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Service and Health Among Deployed Veterans (SHADE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
| Condition |
|---|
| Pulmonary Function |
| Study Type: | Observational [Patient Registry] |
| Study Design: | 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 |
- 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
- 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.
| Estimated Enrollment: | 6200 |
| Anticipated Study Start Date: | July 1, 2017 |
| Estimated Study Completion Date: | October 31, 2022 |
| Estimated Primary Completion Date: | April 30, 2021 (Final data collection date for primary outcome measure) |
| 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
|
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02825654
| Contact: Nicholas L Smith, PhD | (206) 764-2773 | Nicholas.Smith@va.gov | |
| Contact: Karen S Nakayama, BA | (206) 277-3587 | Karen.Nakayama@va.gov |
| United States, Massachusetts | |
| VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA | Not yet recruiting |
| West Roxbury, Massachusetts, United States, 02132 | |
| Contact: Eric Garshick, MD 857-203-5536 Eric.Garshick@va.gov | |
| Contact: Paul D Blanc, MD MSPH (415) 221-4810 ext 3573 | |
| Principal Investigator: Eric Garshick, MD | |
| 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 |
More Information
Additional Information:
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT02825654 History of Changes |
| Other Study ID Numbers: |
595 |
| Study First Received: | June 21, 2016 |
| Last Updated: | May 15, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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 |
ClinicalTrials.gov processed this record on July 17, 2017