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

August 19, 2021 updated by: VA Office of Research and Development

CSP #579 - Long Term Health Outcomes of Women's Service During the Vietnam Era

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4219

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Charleston, California, United States, 29401-5799
    - Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

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.

Group / Cohort

Vietnam-Era Women Veterans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	two years
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.	two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2010

Primary Completion (Actual)

August 7, 2012

Study Completion (Actual)

August 7, 2012

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 12, 2009

First Posted (Estimate)

August 13, 2009

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.