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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00958061
First received: August 11, 2009
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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
Post-Traumatic Stress Disorder
Depression
Diabetes
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: CSP #579 - Long Term Health Outcomes of Women's Service During the Vietnam Era

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Determine the prevalence of lifetime and current psychiatric conditions including PTSD among women who served during the Vietnam Era. [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the physical health of women who served during the Vietnam Era. [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Characterize the level of current disability in women who served during the Vietnam Era. [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 4219
Study Start Date: March 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

  Eligibility

Genders Eligible for Study:   Female
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958061

Locations
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
Investigators
Study Chair: Kathryn M. Magruder, PhD MPH BA Ralph H Johnson VA Medical Center, Charleston
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00958061     History of Changes
Other Study ID Numbers: 579
Study First Received: August 11, 2009
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
CVD

Additional relevant MeSH terms:
Depression
Cardiovascular Diseases
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014