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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 12, 2013
First Posted Date November 19, 2013
Results First Submitted Date May 23, 2017
Results First Posted Date September 12, 2018
Last Update Posted Date September 12, 2018
Actual Study Start Date October 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2018)
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.
Original Primary Outcome Measures
 (submitted: November 12, 2013)
Determine the best methods for recruitment of participants into the study to collect Phase 1 and Phase 2 information. [ Time Frame: 18 months ]
From the national sample, we will compare the participation rates obtained in each of the 4 recruitment approaches for Phase 1. Among a sample of Veterans living in the greater Boston area (those registered and not previously registered for VHA care), we will calculate the participation rates for Phase 2.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: November 12, 2013)
  • Characterize the sample of participants compared with non-participants in terms of demographic and exposure characteristics. [ Time Frame: 18 months ]
    From the national sample, we will characterize the sample of Phase 1 participants compared with non-participants in terms of exposure profiles and DMDC-obtained demographic characteristics, such as sex, deployment status, branch of service, and distance from a VHA medical center, to evaluate potential recruitment biases. Among participants completing Phase 1, we will examine the demographic and exposure characteristics of the participants who indicated willingness to participate in a full study Phase 2 data collection, compared with participants who completed the health and military service survey but indicated they would not be willing to participate in a full study Phase 2. Among a sample of Veterans living in the greater Boston area, we will compare the military, exposure, and health characteristics of persons who participated compared with those who did not participate in Phase 2.
  • Determine the feasibility and acceptability of Phase 2 data collection procedures. [ Time Frame: 18 months ]
    From the national sample, we will gauge the willingness of those who completed Phase 1 to participate in a full study Phase 2 by asking Veterans if they would be willing to complete a 2-hour in-person visit to their nearest VHA medical center to collect detailed health and exposure questionnaires and to undergo pulmonary function testing. Among a sample of Veterans living in the greater Boston area, we will gauge the feasibility and participant-acceptability of performing Phase 2 data collection procedures involving spirometry and the longer in-person questionnaire.
  • Determine the feasibility of the proposed individual exposure reconstruction techniques and provide the range of particulate matter exposure estimates. [ Time Frame: 18 months ]
    From the national sample, we will construct individual exposure histories by linking aerosol optical density satellite data of Afghanistan and Iraq to deployment location (via geographic information system techniques) to characterize the variation in particulate matter levels determined among these individual exposure histories.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Service and Health During the Iraq and Afghanistan Era
Official Title CSP #595Pilot - Respiratory Health and Deployment to Iraq and Afghanistan Pilot
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 50 Years
Biospecimen Not Provided
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.
Condition Iraq and Afghanistan Era Veterans
Intervention Not Provided
Study Groups/Cohorts Iraq and Afghanistan Era Veterans
Veterans who served during the Iraq and Afghanistan Era
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 10, 2018)
1242
Original Estimated Enrollment
 (submitted: November 12, 2013)
2760
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01987401
Other Study ID Numbers 595Pilot
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party VA Office of Research and Development
Study Sponsor VA Office of Research and Development
Collaborators Not Provided
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
PRS Account VA Office of Research and Development
Verification Date September 2018