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

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ClinicalTrials.gov Identifier: NCT00958061
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):

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
Primary Completion Date : August 7, 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958061


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:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00958061     History of Changes
Other Study ID Numbers: 579
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017
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