Clinical trial NCT01803854: Gulf War Era Cohort and Biorepository
Official title: CSP # 585 - Pilot Study: Gulf War Era Cohort and Biorepository
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gulf War Era Cohort
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-03-04
Enrollment: 1275
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Veterans who served in the military in 1990-1991 without regard to actual deployment.

Brief summary: The Gulf War Era Cohort and Biorepository pilot project collected epidemiological, survey, clinical, and environmental exposure data from Veterans who served during the 1990-1991 Gulf War Era. Approved researchers will be able to use these data and the blood samples to do future research about the health of Gulf War Era Veterans.

During the pilot, the recruitment response rate and processes were assessed. The results revealed several opportunities for improvement. For this reason, CSP 585 research activities transitioned to a qualitative phase to focus more on the Veteran voice. In this stage, research staff spoke with Gulf War Era Veterans through focus groups, interviews, and other activities such as events and meetings to learn more about Veterans' experiences and/or ideas on this and other Gulf War research projects. This phase provided new information that can help researchers create better recruitment processes for future projects involving Gulf War Era Veterans.

For more information on CSP 585, please contact Ashlyn Press at Ashlyn.Press@va.gov.

Detailed description: To date, the Department of Veterans Affairs (VA), the Department of Defense (DoD), and the Department of Health and Human Services have funded many research projects pertaining to the health consequences of military service in the 1990-1991 Gulf War. This past research represents a tremendous investment into understanding the medical conditions of these Veterans. However, many important questions remain to be answered about conditions affecting Gulf War Era Veterans. In addition, the Gulf War Era Veteran population is entering the age range at which the incidence of chronic diseases increases rapidly, and other questions are arising regarding the health and medical care of this important cohort.

The Gulf War Era Cohort and Biorepository pilot project collected epidemiological, survey, clinical, and environmental exposure data from Veterans who served during the 1990-1991 Gulf War Era. The goal was to enable the availability of blood specimens and health information for future immunologic, epidemiological, clinical, and health services research. During the pilot, the recruitment response rate and other operational and logistical aspects were assessed. Results indicated that our current recruitment processes were suboptimal for achieving our desired number of participants, and provide opportunities for improvement. To this end, CSP 585 research activities transitioned to a qualitative phase to focus more on the Veteran voice and learn more about how to effectively recruit Gulf War Era Veterans for a project like this. This phase provided new information that will inform recruitment processes for future projects involving Gulf War Era Veterans.

Specific Aims - The Gulf War Era Cohort and Biorepository pilot project was a minimal risk observational pilot project to test the processes needed to establish a research cohort and biorepository of Gulf War Era Veterans. There were no research questions or hypotheses. The pilot project had two specific aims:

1. assess the feasibility and efficacy of the planned recruitment, consenting, and blood drawing and shipping processes, and of modifications to the processes (if necessary); and
2. develop, test, and implement the database structures required for subject enrollment tracking, blood sample tracking, and data storage.

Veterans of the Gulf War Era were identified largely through existing VA and Department of Defense registries and databases. Some Veterans voluntarily joined and were eligible if they served in the military during 1990-91 without regard to actual deployment. The study database contains information collected from the Gulf War Era Veterans' Survey. Additional data will be collected from national VA and non-VA resources and from other studies of Gulf War Era Veterans.

Importance - There has been substantial research into the health care needs of Gulf War Era Veterans, but the incidence of chronic diseases that should be expected as this population ages is uncertain. Furthermore, the relationships between exposures, genetic susceptibility, and these illnesses have not been explored comprehensively in a large cohort. Data from the cohort described in this protocol includes survey data, plasma and access to VA and non-VA medical records, which can provide valuable resources for identifying risk factors as well as other chronic and aging related diseases. These data can then be used to identify the current and future health care needs of Gulf War Era Veterans to more effectively target programs towards them.

The intended users of the Gulf War Era Research Database and blood specimens are researchers who are specifically interested in illnesses affecting Gulf War Era Veterans, and researchers interested in the physical and mental health concerns that affect a population of this age group. The availability of a research cohort with the particular demographics and the documented experiences of Gulf War Era service will enable more detailed analyses regarding diagnosis and treatment of conditions affecting an aging population than is possible with administrative databases alone. With insights from analyses of data and blood specimens from this project, as well as others, the VA will be better able to focus interventions to improve diagnosis, treatment, and outcomes of care.

For more information on CSP 585, please contact Ashlyn.Press@va.gov.

Eligibility criteria: Inclusion Criteria:

* A potential participant must have been a member of the uniformed services during the 1990-1991 Gulf War era.
* 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 who did not serve in the military in 1990-1991 without regard to actual deployment.

Primary outcomes:
measure: VHA Health Care Utilization
timeFrame: 20 months
measure: Deployment
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Dawn Provenzale, MD MS
role: STUDY_CHAIR
References: