Vietnam Era Health Retrospective Observational Study

Aging Clinical Trial

— VE-HEROeS  

Official title:

Vietnam Era Health Retrospective Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02825602
• Other study ID #: 15-12
• Status: Active, not recruiting
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Veteran Affairs Office of Patient Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Vietnam Era Health Retrospective Observational Study (VE-HEROeS) is a national study on the health and well-being of Vietnam Veterans, including Blue Water Navy Veterans, as well as Veterans who served elsewhere during the Vietnam Era (1961-1975), and similarly aged U.S. residents who never served in the military. The investigators will invite approximately 43,000 Vietnam and Vietnam Era Veterans, and approximately 11,000 members of the general U.S. population to participate in VE-HEROeS. These individuals are scientifically selected to participate; the study is not able to accept volunteers.

All participants in VE-HEROeS will be asked to fill out a questionnaire on their military service, general health, age-related conditions, health care use, and the health experiences of their children and grandchildren. A smaller group will be asked to provide the investigators with access to some of their medical records. Topics of special focus for the study include cognition, hepatitis C infection, and neurologic conditions.

Description:

It has been more than 40 years since the Vietnam War ended and there is little recent systematic knowledge of how Veterans of the Vietnam Era (1961-1975) have fared with regard to their overall health, lifestyle factors, and aging. This epidemiologic study, called the Vietnam Era Health Retrospective Observational Study (VE-HEROeS) will provide information about the health and well-being of Veterans of the Vietnam Era to Veterans and their families who have questions about the long-term health effects of service during the Vietnam War, to clinicians who care for Veterans and lack sufficient evidence to explain health conditions, and to the VA healthcare system in order to improve VA healthcare and anticipate future healthcare needs. The main objective of this study is to determine if the overall health of Veterans of the Vietnam War and Vietnam Era, with a special focus on neurologic conditions and hepatitis C infection, is different from that of their counterparts who did not serve in the military. Exploratory aims of the study are to determine if the investigators can obtain a sample of Blue Water Navy Vietnam Veterans (who served exclusively in deep coastal waters off of North or South Vietnam) and use the survey to describe their current health, and to determine the prevalence of Veterans who attribute health conditions of their descendants to their own military service, especially conditions potentially transmitted epigenetically. The study design is a survey, with hepatitis C and neurologic conditions validated by medical record review. The questionnaire includes both validated scales and new items about physical and mental health, exposures, and lifestyle. There are two versions of the questionnaire: one for Veterans of the Vietnam Era and one for those selected from the U.S. general population who have never served in the military. The questionnaires are as similar as possible, with the exception of questions about military service, exposures, or experiences that are either removed or modified in the non-Veteran questionnaire because they do not apply to this population.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24306
• Est. completion date: December 2019
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 58 Years and older

Eligibility

Inclusion Criteria:

• invited to participate through investigators' random sample selection process

• able to provide informed consent

• have a postal address in the U.S. or its territories

Exclusion Criteria:

• individuals who are incarcerated

• individuals who are unable to complete the survey even with assistance because of cognitive or physical limitations.

Related Conditions & MeSH terms

• Aging
• Combat Disorders

Locations

Country	Name	City	State
United States	U.S. Department of Veterans Affairs/Epidemiology Program	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Veteran Affairs Office of Patient Care Services

Country where clinical trial is conducted

United States, 

References & Publications (15)

Bullman TA, Kang HK. Posttraumatic stress disorder and the risk of traumatic deaths among Vietnam veterans. J Nerv Ment Dis. 1994 Nov;182(11):604-10. — View Citation

Dominitz JA, Boyko EJ, Koepsell TD, Heagerty PJ, Maynard C, Sporleder JL, Stenhouse A, Kling MA, Hrushesky W, Zeilman C, Sontag S, Shah N, Ona F, Anand B, Subik M, Imperiale TF, Nakhle S, Ho SB, Bini EJ, Lockhart B, Ahmad J, Sasaki A, van der Linden B, Toro D, Martinez-Souss J, Huilgol V, Eisen S, Young KA. Elevated prevalence of hepatitis C infection in users of United States veterans medical centers. Hepatology. 2005 Jan;41(1):88-96. — View Citation

Health status of Vietnam veterans. I. Psychosocial characteristics. The Centers for Disease Control Vietnam Experience Study. JAMA. 1988 May 13;259(18):2701-7. — View Citation

Health status of Vietnam veterans. II. Physical Health. The Centers for Disease Control Vietnam Experience Study. JAMA. 1988 May 13;259(18):2708-14. — View Citation

Health status of Vietnam veterans. III. Reproductive outcomes and child health. The Centers for Disease Control Vietnam Experience Study. JAMA. 1988 May 13;259(18):2715-9. — View Citation

Institute of Medicine. Blue Water Navy Veterans and Agent Orange Exposure. Washington, DC: The National Academies Press; 2011

Institute of Medicine. Veterans and Agent Orange: Health Effects of Herbicides used in Vietnam: National Academy Press; 1994

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. — View Citation

Kulka RA, Schlenger WE, Fairbank JA, Hough RL, Jordan BK, Marmar CR, et al. Trauma and the Vietnam War Generation. New York: Brunner/Mazel Publishers; 1990

Manikkam M, Tracey R, Guerrero-Bosagna C, Skinner MK. Dioxin (TCDD) induces epigenetic transgenerational inheritance of adult onset disease and sperm epimutations. PLoS One. 2012;7(9):e46249. doi: 10.1371/journal.pone.0046249. Epub 2012 Sep 26. — View Citation

Marmar CR, Schlenger W, Henn-Haase C, Qian M, Purchia E, Li M, Corry N, Williams CS, Ho CL, Horesh D, Karstoft KI, Shalev A, Kulka RA. Course of Posttraumatic Stress Disorder 40 Years After the Vietnam War: Findings From the National Vietnam Veterans Longitudinal Study. JAMA Psychiatry. 2015 Sep;72(9):875-81. doi: 10.1001/jamapsychiatry.2015.0803. — View Citation

Raymont V, Salazar AM, Krueger F, Grafman J. "Studying injured minds" - the Vietnam head injury study and 40 years of brain injury research. Front Neurol. 2011 Mar 28;2:15. doi: 10.3389/fneur.2011.00015. eCollection 2011. — View Citation

The association of selected cancers with service in the US military in Vietnam. I. Non-Hodgkin's lymphoma. The Selected Cancers Cooperative Study Group. Arch Intern Med. 1990 Dec;150(12):2473-83. — View Citation

The association of selected cancers with service in the US military in Vietnam. II. Soft-tissue and other sarcomas. The Selected Cancers Cooperative Study Group. Arch Intern Med. 1990 Dec;150(12):2485-92. — View Citation

The association of selected cancers with service in the US military in Vietnam. III. Hodgkin's disease, nasal cancer, nasopharyngeal cancer, and primary liver cancer. The Selected Cancers Cooperative Study Group. Arch Intern Med. 1990 Dec;150(12):2495-505. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-identification of Blue Water Navy Vietnam Veterans	The investigators will ask Blue Water Navy Veterans to define themselves by their response to a survey question, as no roster of these Veterans exists.	Navy service exclusively in the deep offshore waters of Vietnam between February 28, 1961 and May 7, 1975.
Other	Health of offspring	We ask survey respondents to report 9 conditions of their children and grandchildren that may be transmitted epigenetically	Health history assessed at the time of survey (Day 1)
Primary	Overall Health	Overall health will be measured by the mean physical component summary score (PCS) and the mean mental component score (MCS) of the Short Form 8 (SF-8) compared across the four groups. Mean scores on the 8 health concepts measured by the SF-8 (physical functioning, role limitations due to physical functioning, bodily pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems, and psychological distress/well being) will also be compared. Adjustments may be made for age, gender, and prevalent co-morbidities.	Past 4 weeks
Secondary	Conditions of concern	The investigators will compare post-war prevalence of conditions that have been linked to Vietnam War service in other scientific studies of multiple designs: neurologic conditions ( Parkinson's disease, dementia, stroke, brain injury), Hepatitis C; hypertension, ischemic heart disease, Type II diabetes, peripheral neuropathy, various cancers, cirrhosis, alcohol and drug dependency.	Health history assessed at the time of survey (Day 1)