NCT02825602

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24,306

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

June 13, 2016

Last Update Submit

April 23, 2019

Conditions

Keywords

Vietnam veteranaginghealthWar InjuryConventional WarfareToxic EffectChemical

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Conditions of concern

    Health history assessed at the time of survey (Day 1)

Other Outcomes (2)

  • Self-identification of Blue Water Navy Vietnam Veterans

    Navy service exclusively in the deep offshore waters of Vietnam between February 28, 1961 and May 7, 1975.

  • Health of offspring

    Health history assessed at the time of survey (Day 1)

Study Arms (4)

Vietnam War Theater Veterans

Vietnam War Theater Veterans are defined for this protocol as those who served in the U.S. Armed Forces on the ground, in the air, or on the inland waters of Vietnam, Cambodia, and/or Laos between February 28, 1961 and May 7, 1975, inclusive. The investigators based this definition on legal dates of service set forth in 38 Code of Federal Regulations (CFR) 3.2 - Periods of war, but broadened the definition of sites of military service that constituted war zones based on written historical accounts and input from Vietnam Veterans.

Blue Water Navy Vietnam Veterans

Blue Water Navy Veterans are defined as Veterans who served aboard deep-water naval vessels in waters offshore North or South Vietnam between February 28, 1961 and May 7, 1975 and who never served ashore or on inland waterways of Vietnam.

Vietnam era Veterans

Vietnam era Veterans served in locations around the world OTHER than on the ground, in the air, or on the inland waters of Vietnam, Cambodia, and/or Laos or aboard deep-water naval vessels in waters offshore North or South Vietnam between February 28, 1961 and May 7, 1975.

Non-military U.S. public

Non-military U.S. public are individuals who were born before 1958, never served in the U.S. military, and are age- and gender-matched (by the study investigators) to Vietnam War Theater Veterans.

Eligibility Criteria

Age58 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Veterans: We will obtain a stratified random sample of 45,067 Veterans from the Department of Veterans Affairs' United States Veterans Eligibility Trends \& Statistics (USVETS) database which we believe to be the most complete database of U.S. military Veterans in existence. Stratification will be on period of service within the Vietnam era: 1961-1964 or 1965-1975. We will remove decedents and those without a current US postal address from the sample. U.S. public: The U.S. public general population comparison sample will be an age- and gender-matched sample of living non-Veteran members of the U.S. public born before 1958.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.S. Department of Veterans Affairs/Epidemiology Program

Washington D.C., District of Columbia, 20420, United States

Location

Related Publications (16)

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

    PMID: 2833631BACKGROUND
  • Health status of Vietnam veterans. I. Psychosocial characteristics. The Centers for Disease Control Vietnam Experience Study. JAMA. 1988 May 13;259(18):2701-7.

    PMID: 2833630BACKGROUND
  • 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.

    PMID: 2833632BACKGROUND
  • 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

    BACKGROUND
  • Institute of Medicine (US) Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides. Veterans and Agent Orange: Health Effects of Herbicides Used in Vietnam. Washington (DC): National Academies Press (US); 1994. Available from http://www.ncbi.nlm.nih.gov/books/NBK236356/

    PMID: 25144022BACKGROUND
  • 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. doi: 10.1002/hep.20502.

    PMID: 15619249BACKGROUND
  • 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.

    PMID: 21625624BACKGROUND
  • 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. doi: 10.1097/00005053-199411000-00002.

    PMID: 7964667BACKGROUND
  • 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.

    PMID: 26201054BACKGROUND
  • 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.

    PMID: 23049995BACKGROUND
  • 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. doi: 10.1001/archinte.150.12.2495.

    PMID: 2244766BACKGROUND
  • 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.

    PMID: 2244764BACKGROUND
  • 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.

    PMID: 2244765BACKGROUND
  • 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.

    PMID: 24488510BACKGROUND
  • Institute of Medicine (US) Committee on Blue Water Navy Vietnam Veterans and Agent Orange Exposure. Blue Water Navy Vietnam Veterans and Agent Orange Exposure. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK209599/

    PMID: 24983057BACKGROUND
  • Blosnich JR, Hilgeman MM, Cypel YS, Akhtar FZ, Fried D, Ishii EK, Schneiderman A, Davey VJ. Potentially traumatic events and health among lesbian, gay, bisexual and heterosexual Vietnam veterans: Results from the Vietnam Era Health Retrospective Observational study. Psychol Trauma. 2022 May;14(4):568-577. doi: 10.1037/tra0001025. Epub 2021 Jun 17.

MeSH Terms

Conditions

Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Victoria J Davey, PhD, MPH

    US Department of Veterans Affairs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Investigator, Epidemiology Program

Study Record Dates

First Submitted

June 13, 2016

First Posted

July 7, 2016

Study Start

July 1, 2016

Primary Completion

March 31, 2017

Study Completion

December 1, 2019

Last Updated

April 24, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

Aggregate data will be available to investigators in accordance with VA access policy.

Locations