Long Term Health Outcomes of Women Veterans' Service During the Vietnam Era (Health ViEWS)

• ClinicalTrials.gov Identifier: NCT00958061
• Recruitment Status: Completed
• First Posted: August 13, 2009
• Last Update Posted: August 25, 2021
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

Little is known about the long-term health and mental health status of women Vietnam veterans. For many of these women, the effects of this war are still present in their daily lives. As these women approach their mid-sixties, it is important to understand the impact of wartime deployment on health and mental health outcomes nearly 40 years later. The investigators propose to assess the prevalence of posttraumatic stress disorder (PTSD) and other mental and physical health conditions for women Vietnam veterans, and to explore the relationship between PTSD and other conditions and the Vietnam deployment experience. The investigators are interested in studying women Vietnam veterans who may have had direct exposure to traumatic events. For the first time, the investigators also want to study those who served in facilities near Vietnam. These women may have had similar, but less direct exposures. This cross-sectional study will seek to contact approximately 10,000 women for participation in a mailed survey, telephone interview and a review of their medical records. Women identified as serving in Vietnam, near Vietnam (in Asia during the Vietnam Ware) and in the U.S. during the Vietnam War will be identified from an established cohort and sent a survey on demographics, behaviors, disability, health-related quality of life, and medical conditions. Women agreeing to be contacted will also be interviewed by study investigators using the modified CIDI to ascertain current and lifetime mental health conditions (including PTSD) and exposure to traumatic events. A more extensive chart review will be conducted by a clinician to validate self-report of key medical conditions.

Condition or disease
Post-Traumatic Stress Disorder; Depression; Diabetes; Cardiovascular Disease

Study Design

• Study Type: Observational
• Actual Enrollment: 4219 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: CSP #579 - Long Term Health Outcomes of Women's Service During the Vietnam Era
• Actual Study Start Date: March 1, 2010
• Actual Primary Completion Date: August 7, 2012
• Actual Study Completion Date: August 7, 2012

Groups and Cohorts

Group/Cohort

Vietnam-Era Women Veterans; For this study we will use a cohort of women who are on a roster of Vietnam Era women veterans (4,644 Vietnam, 1,213 near Vietnam, 5,465 non-Vietnam) previously identified and characterized by a review of their military personnel records and link it to a list of 8,061 women who presumably served in Southeast Asia. This final cohort could potentially contain approximately 14,000 women. After deceased individuals are removed from the active cohort and contact information is updated, we estimate that there could be approximately 10,000 women to whom the informed consent and mailed survey will be initially mailed.

Outcome Measures

Primary Outcome Measures :

1. Determine the prevalence of lifetime and current psychiatric conditions including PTSD among women who served during the Vietnam Era. [ Time Frame: two years ]
   The prevalence of lifetime and current psychiatric conditions including PTSD among women who served during the Vietnam Era.

Secondary Outcome Measures :

1. Characterize the physical health of women who served during the Vietnam Era. [ Time Frame: two years ]
   Characterize the physical health of women who served during the Vietnam Era.
2. Characterize the level of current disability in women who served during the Vietnam Era. [ Time Frame: two years ]
   Characterize the level of current disability in women who served during the Vietnam Era.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

For this study we will use a cohort of women who are on a roster of Vietnam Era women veterans (4,644 Vietnam, 1,213 near Vietnam, 5,465 non-Vietnam) previously identified and characterized by a review of their military personnel records and link it to a list of 8,061 women who presumably served in Southeast Asia. This final cohort could potentially contain approximately 14,000 women. After deceased individuals are removed from the active cohort and contact information is updated, we estimate that there could be approximately 10,000 women to whom the informed consent and mailed survey will be initially mailed.

Criteria

Inclusion Criteria:

• Women alive as of survey receipt who were active duty military personnel in one of the four Armed Services between July 4, 1965, and March 28, 1973, with a 30 day minimum period of service.
• This will include those who served in Vietnam, near Vietnam (Guam, the Philippines, Japan, Korea, Okinawa, or Thailand), or in the 50 United States.

Exclusion Criteria:

• Unable or unwilling to provide informed consent

Contacts and Locations

Locations

United States, California

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, California, United States, 29401-5799

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Study Chair: Kathryn M. Magruder, PhD MPH BA; Ralph H. Johnson VA Medical Center, Charleston, SC

More Information

Publications of Results:

Kilbourne AM, Schumacher K, Frayne SM, Cypel Y, Barbaresso MM, Nord KM, Perzhinsky J, Lai Z, Prenovost K, Spiro A, Gleason TC, Kimerling R, Huang GD, Serpi TB, Magruder KM. Physical Health Conditions Among a Population-Based Cohort of Vietnam-Era Women Veterans: Agreement Between Self-Report and Medical Records. J Womens Health (Larchmt). 2017 Nov;26(11):1244-1251. doi: 10.1089/jwh.2016.6069. Epub 2017 Aug 7.

Schmidt EM, Magruder K, Kilbourne AM, Stock EM, Cypel Y, El Burai Felix S, Serpi T, Kimerling R, Cohen B, Spiro A, Furey J, Huang GD, Frayne SM. Four Decades after War: Incident Diabetes among Women Vietnam-Era Veterans in the HealthViEWS Study. Womens Health Issues. 2019 Nov-Dec;29(6):471-479. doi: 10.1016/j.whi.2019.08.002. Epub 2019 Sep 10.

Kimerling R, Serpi T, Weathers F, Kilbourne AM, Kang H, Collins JF, Cypel Y, Frayne SM, Furey J, Huang GD, Reinhard MJ, Spiro A, Magruder K. Diagnostic accuracy of the Composite International Diagnostic Interview (CIDI 3.0) PTSD module among female Vietnam-era veterans. J Trauma Stress. 2014 Apr;27(2):160-7. doi: 10.1002/jts.21905.

Kang HK, Cypel Y, Kilbourne AM, Magruder KM, Serpi T, Collins JF, Frayne SM, Furey J, Huang GD, Kimerling R, Reinhard MJ, Schumacher K, Spiro A 3rd. HealthViEWS: mortality study of female US Vietnam era veterans, 1965-2010. Am J Epidemiol. 2014 Mar 15;179(6):721-30. doi: 10.1093/aje/kwt319. Epub 2014 Jan 30.

Magruder K, Serpi T, Kimerling R, Kilbourne AM, Collins JF, Cypel Y, Frayne SM, Furey J, Huang GD, Gleason T, Reinhard MJ, Spiro A, Kang H. Prevalence of Posttraumatic Stress Disorder in Vietnam-Era Women Veterans: The Health of Vietnam-Era Women's Study (HealthVIEWS). JAMA Psychiatry. 2015 Nov;72(11):1127-34. doi: 10.1001/jamapsychiatry.2015.1786.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00958061
• Other Study ID Numbers: 579
• First Posted: August 13, 2009
• Last Update Posted: August 25, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by VA Office of Research and Development:

CVD

Additional relevant MeSH terms:

Cardiovascular Diseases; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders