Iraq and Afghanistan Era VeteransCSP #595 PilotNCT01987401
Service and Health During the Iraq and Afghanistan Era
An observational study of Iraq and Afghanistan Era Veterans, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Iraq and Afghanistan Era Veterans
- How many people
- 1,242 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Dec 2015
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Veterans of the Coast Guard, including individuals in respective Guard and Reserve units, are not eligible to participate.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: 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.
Read the 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.
- Conditions
- Iraq and Afghanistan Era Veterans
- Keywords
- pulmonary, lung, military and environmental exposures, epidemiologic, observational, interview or questionnaire, deployment related, Enduring Freedom, Iraqi Freedom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Iraq and Afghanistan Era Veterans | Veterans who served during the Iraq and Afghanistan Era |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Iraq and Afghanistan Era VeteransStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,242 participants (actual)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eric Garshick, MD, Study chair, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MARebecca B McNeil, PhD, Study chair, Durham VA Medical Center, Durham, NCSusan P Proctor, DSc, Study chair, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987401
- Sponsor's protocol ID
- 595Pilot
- Acronym
- CSP #595 Pilot
- Status last verified
- Sep 2018
- First submitted
- 12 Nov 2013
- Last updated
- 12 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #595Pilot - Respiratory Health and Deployment to Iraq and Afghanistan Pilot
- ClinicalTrials.gov ID
- NCT01987401
- Acronym / sponsor ID
- CSP #595 Pilot / 595Pilot
- Conditions
- Iraq and Afghanistan Era Veterans
- Keywords
- pulmonary, lung, military and environmental exposures, epidemiologic, observational, interview or questionnaire, deployment related, Enduring Freedom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,242 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Posted 12 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 50 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iraq and Afghanistan Era Veterans | – | –Veterans who served during the Iraq and Afghanistan Era |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Veterans of the Coast Guard, including individuals in respective Guard and Reserve units, are not eligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study: CSP #595Pilot - Respiratory Health and Deployment to Iraq and Afghanistan PilotLink provided by the sponsor.
- Click here for more information about this study: CSP #595Pilot - Respiratory Health and Deployment to Iraq and Afghanistan PilotLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Garshick, MD study chair
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Rebecca B McNeil, PhD study chair
Durham VA Medical Center, Durham, NC
Susan P Proctor, DSc study chair
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iraq and Afghanistan Era Veterans, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation Rates (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.