Vietnam Era Health Retrospective Observational Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vietnam Era Health Retrospective Observational Study

Conditions
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Aging, Combat Disorders

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 58 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vietnam War Theater Veterans<br>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<br>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<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vietnam veteran, aging, health, War Injury, Conventional Warfare, Toxic Effect, Chemical