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

September 10, 2018 updated by: VA Office of Research and Development

CSP #595Pilot - Respiratory Health and Deployment to Iraq and Afghanistan Pilot

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (ESTIMATE)

November 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 595Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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