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Service and Health During the Iraq and Afghanistan Era (CSP #595 Pilot)

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ClinicalTrials.gov Identifier: NCT01987401
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The primary objective of CSP #595, "Service and Health During the Iraq and Afghanistan Era," is to characterize the impact of deployment to Iraq and Afghanistan on the respiratory health of Veterans. The purpose of the pilot study is to determine the willingness of Veterans who served during the Iraq and Afghanistan Era to provide health and military service information. This information will help us design a larger national study.

Condition or disease
Iraq and Afghanistan Era Veterans

Detailed Description:

The primary objective of CSP #595, "Respiratory Health and Deployment to Iraq and Afghanistan," is to assess the association of airborne exposures encountered during deployment with current measures of respiratory health among U.S. military Veterans who served in Iraq and Afghanistan.

The purpose of the pilot study is to assess the feasibility and approach to conducting a large, multi-site Cooperative Studies Program (CSP) initiative to characterize the impact of deployment to Iraq and Afghanistan on the respiratory health of Veterans. The investigators will (a) determine the most efficient and feasible method for recruitment; (b) understand demographic, health-related, and military service-related factors influencing participation so that potential biases can be identified; and (c) demonstrate that the proposed individual exposure reconstruction techniques based on deployment history are feasible.

Three aims are proposed: Aim 1: Using the Department of Defense (DoD) Defense Manpower Data Center (DMDC) master personnel roster, identify a representative sample of deployed Veterans who have served in Iraq and Afghanistan as well as a sample of non-deployed Veterans; identify the optimal methods for recruitment of participants to Phase 1 of data collection (mailed survey or telephone interview on self-reported health and military service history) and assess the willingness of Veterans to visit a nearby Veterans Health Administration (VHA) medical center to participate in Phase 2 in-person data collection, which includes more extensive self-reported health information, lifetime exposure ascertainment, and assessment of pulmonary function. Aim 2: Assess the Phase 2 participation rate of Veterans using VA Boston Healthcare System as a pilot study site. Aim 3: Using publically available exposure data and data from the DoD personnel file, demonstrate that the proposed individual exposure reconstruction techniques are feasible.

The study is organized by the CSP Epidemiology Center program with the Seattle Epidemiologic Research and Information Center serving as the CSP coordinating center. The 2 participating sites are at the VA Boston Healthcare System and Durham VA Medical Center. The pilot study will provide information that will allow the planning of a national, large-scale health study to assess the residual effects of exposure to high levels of particulate matter while deployed. This will help inform VA health policy for Iraq and Afghanistan Veterans.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 1242 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 50 Years
Official Title: CSP #595Pilot - Respiratory Health and Deployment to Iraq and Afghanistan Pilot
Actual Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Group/Cohort
Iraq and Afghanistan Era Veterans
Veterans who served during the Iraq and Afghanistan Era



Primary Outcome Measures :
  1. Participation Rates [ Time Frame: 18 months ]
    From the national sample, the investigators will compare participation rates for the mailed survey and telephone survey. Among a sample of Veterans living in the greater Boston area, the investigators will calculate participation rate for the in-person survey.



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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
Veterans who served during the Iraq and Afghanistan Era, without regard to actual deployment, identified from the Department of Defense (DoD) Defense Manpower Data Center (DMDC) master personnel roster of all persons serving during the time period of interest.
Criteria

Inclusion Criteria:

  • All competent, living men and women who served during the Iraq and Afghanistan Era and been discharged from the Army, Air Force, Marine Corps, or Navy are eligible to participate.
  • Individuals in respective Guard and Reserve units are also eligible to participate.
  • A Veteran is eligible without regard to deployment or combat status and without regard to current or past user status in the Veterans Health Administration.

Exclusion Criteria:

  • Veterans of the Coast Guard, including individuals in respective Guard and Reserve units, are not eligible to participate.

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): NCT01987401


Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
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
Investigators
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Study Chair: Eric Garshick, MD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study Chair: Rebecca B McNeil, PhD Durham VA Medical Center, Durham, NC
Study Chair: Susan P Proctor, DSc VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Additional Information:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01987401     History of Changes
Other Study ID Numbers: 595Pilot
First Posted: November 19, 2013    Key Record Dates
Results First Posted: September 12, 2018
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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