Gulf War Era Cohort and Biorepository (CSP# 585)

CSP # 585 - Pilot Study: Gulf War Era Cohort and Biorepository

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gulf War Era Cohort

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.

• Study Type: Observational
• Enrollment (Actual): 1275

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Durham VA Medical Center, Durham, NC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Veterans who served in the military in 1990-1991 without regard to actual deployment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Gulf War Era Veterans; All Veterans who served in the uniformed services during 1990-1991 who signed consent forms, completed a survey, and provided a blood sample are included in the cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VHA Health Care Utilization	Use of VHA for health care in the past year	20 months
Deployment	Deployment in support of 1990-1991 Gulf War	20 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Study Chair: Dawn Provenzale, MD MS, Durham VA Medical Center, Durham, NC

Publications and helpful links

General Publications

• Khalil L, McNeil RB, Sims KJ, Felder KA, Hauser ER, Goldstein KM, Voils CI, Klimas NG, Brophy MT, Thomas CM, Whitley RL, Dursa EK, Helmer DA, Provenzale DT. The Gulf War Era Cohort and Biorepository: A Longitudinal Research Resource of Veterans of the 1990-1991 Gulf War Era. Am J Epidemiol. 2018 Nov 1;187(11):2279-2291. doi: 10.1093/aje/kwy147.
• Brown MC, Sims KJ, Gifford EJ, Goldstein KM, Johnson MR, Williams CD, Provenzale D. Gender-based Differences among 1990-1991 Gulf War Era Veterans: Demographics, Lifestyle Behaviors, and Health Conditions. Womens Health Issues. 2019 Jun 25;29 Suppl 1(Suppl 1):S47-S55. doi: 10.1016/j.whi.2019.04.004.
• Vahey J, Hauser ER, Sims KJ, Helmer DA, Provenzale D, Gifford EJ. Research tool for classifying Gulf War illness using survey responses: Lessons for writing replicable algorithms for symptom-based conditions. Life Sci. 2021 Oct 1;282:119808. doi: 10.1016/j.lfs.2021.119808. Epub 2021 Jul 6.
• Gifford EJ, Vahey J, Hauser ER, Sims KJ, Efird JT, Dursa EK, Steele L, Helmer DA, Provenzale D. Gulf War illness in the Gulf War Era Cohort and Biorepository: The Kansas and Centers for Disease Control definitions. Life Sci. 2021 Aug 1;278:119454. doi: 10.1016/j.lfs.2021.119454. Epub 2021 Mar 31.
• Vahey J, Gifford EJ, Sims KJ, Chesnut B, Boyle SH, Stafford C, Upchurch J, Stone A, Pyarajan S, Efird JT, Williams CD, Hauser ER. Gene-Toxicant Interactions in Gulf War Illness: Differential Effects of the PON1 Genotype. Brain Sci. 2021 Nov 25;11(12):1558. doi: 10.3390/brainsci11121558.
• Gifford EJ, Boyle SH, Vahey J, Sims KJ, Efird JT, Chesnut B, Stafford C, Upchurch J, Williams CD, Helmer DA, Hauser ER. Health-Related Quality of Life by Gulf War Illness Case Status. Int J Environ Res Public Health. 2022 Apr 7;19(8):4425. doi: 10.3390/ijerph19084425.

Helpful Links

• An Assessment of Survey Measures Used Across Key Epidemiologic Studies of United States Gulf War I Era Veterans
• Click here for more information about this study: CSP # 585 - Pilot Study: Gulf War Era Cohort and Biorepository

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2014
• Primary Completion (Actual): July 21, 2019
• Study Completion (Estimated): July 21, 2024

Study Registration Dates

• First Submitted: February 14, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimated): March 4, 2013

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 585; 11-09 (Other Identifier: Central IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No