Vietnam Era Health Retrospective Observational Study (VE-HEROeS)

April 23, 2019 updated by: Victoria J. Davey PhD, MPH, Veteran Affairs Office of Patient Care Services

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

24306

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
    • District of Columbia
      • Washington, District of Columbia, United States, 20420
        • U.S. Department of Veterans Affairs/Epidemiology Program

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

58 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

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.

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

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Health
Time Frame: Past 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conditions of concern
Time Frame: Health history assessed at the time of survey (Day 1)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-identification of Blue Water Navy Vietnam Veterans
Time Frame: Navy service exclusively in the deep offshore waters of Vietnam between February 28, 1961 and May 7, 1975.
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.
Health of offspring
Time Frame: Health history assessed at the time of survey (Day 1)
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)

Collaborators and Investigators

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

Sponsor

Veteran Affairs Office of Patient Care Services

Investigators

  • Principal Investigator: Victoria J Davey, PhD, MPH, US Department of Veterans Affairs

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

July 1, 2016

Primary Completion (ACTUAL)

March 31, 2017

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (ESTIMATE)

July 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

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.

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