Service and Health During the Iraq and Afghanistan Era - Full Text View

Purpose

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
Iraq and Afghanistan Era Veterans


Study Type:	Observational [Patient Registry]
Study Design:	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

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:

Participation Rates [ Time Frame: 18 months ]
From the national sample, the investigators will compare Phase 1 participation rates obtained in each of the 4 recruitment approaches and characterize the sample of participants compared with non-participants in terms of exposure profiles and DMDC-obtained demographic characteristics to evaluate potential recruitment biases. Among a sample of Veterans living in the greater Boston area, the investigators will calculate Phase 2 participation rates and compare the military, exposure, and health characteristics of participants with non-participants.


Estimated Enrollment:	2760
Study Start Date:	October 2014
Estimated Study Completion Date:	August 2018
Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts
Iraq and Afghanistan Era Veterans Veterans who served during the Iraq and Afghanistan Era

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
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.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987401

Locations


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


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

More Information

Additional Information:

Click here for more information about this study: CSP #595Pilot - Respiratory Health and Deployment to Iraq and Afghanistan Pilot This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Click here for more information about this study: CSP #595Pilot - Respiratory Health and Deployment to Iraq and Afghanistan Pilot This link exits the ClinicalTrials.gov site


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT01987401 History of Changes
Other Study ID Numbers:	595Pilot
Study First Received:	November 12, 2013
Last Updated:	June 28, 2016
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

ClinicalTrials.gov processed this record on July 17, 2017

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