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

Depression Clinical Trial

— Health ViEWS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958061
• Other study ID #: 579
• Status: Completed
• Start date: March 1, 2010
• Est. completion date: August 7, 2012

Study information

• Verified date: August 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4219
• Est. completion date: August 7, 2012
• Est. primary completion date: August 7, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Depression
• Diabetes
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 — View Citation

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 Ve — View Citation

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 Vietna — View Citation

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 — View Citation

Schmidt EM, Magruder K, Kilbourne AM, Stock EM, Cypel Y, El Burai Félix 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 He — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the prevalence of lifetime and current psychiatric conditions including PTSD among women who served during the Vietnam Era.	The prevalence of lifetime and current psychiatric conditions including PTSD among women who served during the Vietnam Era.	two years
Secondary	Characterize the physical health of women who served during the Vietnam Era.	Characterize the physical health of women who served during the Vietnam Era.	two years
Secondary	Characterize the level of current disability in women who served during the Vietnam Era.	Characterize the level of current disability in women who served during the Vietnam Era.	two years