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Service and Health During the Iraq and Afghanistan Era

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01987401
Acronym
CSP #595 Pilot
Enrollment
1242
Registered
2013-11-19
Start date
2014-10-31
Completion date
2015-12-31
Last updated
2018-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iraq and Afghanistan Era Veterans

Keywords

pulmonary, lung, military and environmental exposures, epidemiologic, observational, interview or questionnaire, deployment related, Enduring Freedom, Iraqi Freedom

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.

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.

Interventions

None listed

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Participation Rates18 monthsFrom 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Mail
Received mail survey
591
Phone
Received phone survey
591
In-Person
Invited to in-person survey
60
Total1,242

Baseline characteristics

CharacteristicMailTotalIn-PersonPhone
Age, Continuous38.2 years
STANDARD_DEVIATION 10.9
38.7 years
STANDARD_DEVIATION 11.1
36.7 years
STANDARD_DEVIATION 10.6
39.4 years
STANDARD_DEVIATION 11.5
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants10 Participants0 Participants5 Participants
Race (NIH/OMB)
Asian
24 Participants49 Participants3 Participants22 Participants
Race (NIH/OMB)
Black or African American
89 Participants189 Participants3 Participants97 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
21 Participants42 Participants3 Participants18 Participants
Race (NIH/OMB)
White
452 Participants952 Participants51 Participants449 Participants
Region of Enrollment
United States
591 participants1242 participants60 participants591 participants
Sex: Female, Male
Female
87 Participants188 Participants8 Participants93 Participants
Sex: Female, Male
Male
504 Participants1054 Participants52 Participants498 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 5910 / 5910 / 60
other
Total, other adverse events
0 / 5910 / 5910 / 60
serious
Total, serious adverse events
0 / 5910 / 5910 / 60

Outcome results

Primary

Participation Rates

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.

Time frame: 18 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mailed SurveyParticipation Rates137 Participants
Telephone SurveyParticipation Rates121 Participants
In-person SurveyParticipation Rates14 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026