Post-Deployment Afghanistan/Iraq Trauma Related Inventory of Traits (PATRIOT): Phase 1 (Feasibility Study) (PATRIOT)
|First Received Date ICMJE||June 28, 2010|
|Last Updated Date||May 16, 2014|
|Start Date ICMJE||September 2011|
|Primary Completion Date||September 2012 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01153529 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Post-Deployment Afghanistan/Iraq Trauma Related Inventory of Traits (PATRIOT): Phase 1 (Feasibility Study)|
|Official Title ICMJE||CSP #575 - Post-Deployment Afghanistan/Iraq Trauma Related Inventory of Traits (PATRIOT): Phase 1 (Feasibility Study)|
The long-term goal of this research project is to identify genes that contribute to or guard against developing posttraumatic stress disorder (PTSD) and to better understand how genes and life experiences work together to impact PTSD. Inherited traits are passed down from one generation to the next in genes. Genes contain molecules called DNA, which contain the information that determines our characteristics and carries instructions for constructing and operating our body. Most human diseases have an inherited element. In addition, we, the investigators, hope to learn about how genes and the other materials we find in participants' blood relate to other illnesses and behaviors.
The goal of the feasibility project covered by this application is to test the possibility of conducting research on a large number of veterans in order to look at the association between genes and PTSD. We are inviting 1,000 OEF/OIF veterans to participate, of these, we are anticipating approximately 250 veterans who have served in Afghanistan and/or Iraq to participate in this study. Although 250 participants is our target enrollment, we plan to enroll all veterans included in our initial mailings who desire to participate. We do not anticipate this to exceed 500 individuals. This phase of the study is expected to last about one year. Specific aims are: 1. evaluation of sampling methods and participation rates; 2. field testing of assessment batteries including reliability and validity; and 3. evaluation of the proposed DNA collection and storage procedures.
The primary purpose of this feasibility project is to evaluate the feasibility of collecting a case-control cohort of OEF/OIF veterans that is large enough to make possible the identification of genetic variants that affect the risk for PTSD after exposure to traumatic events.
We will also determine if the DNA samples will be of sufficient quality for subsequent analyses.
The primary purpose of the main project which is not covered by this application is to identify genes that affect the risk of developing PTSD.
The specific aims have been developed for this feasibility phase of a main study that will have the goal of identifying the most important genes that influence risk and resilience for PTSD and understanding how those genes interact with environmental stressors to cause (or protect from) the clinical disorder.
The feasibility phase protocol presented here is designed to:
After the feasibility phase is complete, a protocol for the main study will be planned and submitted for scientific peer review.
The OEF/OIF Roster generated by the Defense Manpower Data Center will be used to obtain a list of veterans who have served in at least one of the two theaters of operation since the beginning of the conflict in Iraq and/or Afghanistan. Access to this roster is managed by the VA Environmental Epidemiology Service (EES). This roster currently contains 1,001,463 veterans, of whom 888,454 are male and 475,155 have sought treatment within the VA. Data points abstracted from the roster include, but are not limited to, name, address, SSN, birth date, combat end date, end service date, separation date, military branch, and deployment country. To achieve our target enrollment of 250, 1,000 veterans from the roster will be randomly selected for potential participation. After the sample of 1,000 is randomly drawn, the Cooperative Studies Program Coordinating Center (CSPCC) will mail out letters inviting study participation. We expect the initial 1,000 mailings to yield the following results:
If the above estimates do not yield a minimum of 250 participants, a second wave of mailings will be sent to a new sample of potential participants (N to be determined based on participation rate from the first N = 1000 mailings). Although 250 participants is our target enrollment, we plan to enroll all veterans included in our initial mailings who desire to participate. We do not anticipate this to exceed 500 individuals.
Potential participants will indicate their interest in this study by returning the response letter or by directly calling a dedicated toll-free telephone number. The VA website (http://www.csp.research.va.gov/ ) will have both descriptive information about the study which participants may view at any time as well as the approved informed consent documents. Participants will have an opportunity to ask questions about the study by contacting the study team at CSPCC. The information that we plan on including in the website is as follows:
While loss of confidentiality cannot be guaranteed and could be a possible risk, steps will be taken to minimize the risk of loss of confidentiality. First, all collected data received by the Cooperative Studies Program Coordinating Center will be stored in locked file cabinets in a locked office to which only study team members will have access. In addition, Study ID numbers will be used to identify materials with participant responses. Any identifying information will be maintained separately (locked cabinet in a different office).
With regards to participant discomfort, the participants are reminded at the beginning of the interview that they can refuse to answer any questions and discontinue participation at any time. If issues related to trauma memories arise, the participants are asked if they want to be contacted by the study clinician or if they would like to be provided with other medical/mental health resources. Participants will also be asked if they need a break at different intervals during the interview should the participant be experiencing any fatigue due to the duration of the survey. If the participant becomes upset, the study clinician will be contacted by the interviewer. If they simply want to talk to the clinician (per exit interview criteria, then they can as well). If the participant requests assistance without being upset or distressed, they will be provided with information to connect with local resources.
The role of the psychologist will be to collaborate with all study staff, work directly with the study clinician, interface with central IRB and will be the first line resource where decisions need to be made and the first line resource for the coordinating center.
The blood sample will be taken by a certified home health nurse who has experience in minimizing and managing venipuncture side effects.
We propose to minimize potential risks related to genetic samples by never revealing genotype information to participants. No genotypes will become part of the participants' medical records. Participant samples will be coded and the same codes will be used to identify participants in the computer database. The computer files will be password protected. Any hard copies will be maintained in locked filing cabinets in a locked office, and the code book will be locked in a different office. Blood samples sent to Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) will be placed in secure storage. Although these blood samples will not be banked as part of the CSPG001 - VA Genomic Medicine Program: Specimen Collection and Banking Protocol, they will be processed using their approved established procedures.
Key Feasibility Outcomes and Resultant Decision Processes
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Retrospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||OEF/OIF Veterans|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Group 1
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||250|
|Completion Date||September 2012|
|Primary Completion Date||September 2012 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
1.Participant must have served in support of Operation Enduring Freedom or Operation Iraqi Freedom (OEF/OIF) as this is a study relevant to these veterans
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01153529|
|Other Study ID Numbers ICMJE||575|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||VA Office of Research and Development|
|Study Sponsor ICMJE||VA Office of Research and Development|
|Collaborators ICMJE||Not Provided|
|PRS Account||VA Office of Research and Development|
|Verification Date||May 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP