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Vietnam Era Health Retrospective Observational Study (VE-HEROeS)

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ClinicalTrials.gov Identifier: NCT02825602
Recruitment Status : Unknown
Verified April 2019 by Victoria J. Davey PhD, MPH, Veteran Affairs Office of Patient Care Services.
Recruitment status was:  Active, not recruiting
First Posted : July 7, 2016
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Victoria J. Davey PhD, MPH, Veteran Affairs Office of Patient Care Services

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.


Condition or disease
Aging Combat Disorders

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.

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Study Type : Observational
Actual Enrollment : 24306 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Vietnam Era Health Retrospective Observational Study
Study Start Date : July 2016
Actual Primary Completion Date : March 31, 2017
Estimated Study Completion Date : December 2019

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   58 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825602


Locations
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United States, District of Columbia
U.S. Department of Veterans Affairs/Epidemiology Program
Washington, District of Columbia, United States, 20420
Sponsors and Collaborators
Veteran Affairs Office of Patient Care Services
Investigators
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Principal Investigator: Victoria J Davey, PhD, MPH US Department of Veterans Affairs
Publications:
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
Institute of Medicine. Veterans and Agent Orange: Health Effects of Herbicides used in Vietnam: National Academy Press; 1994
Institute of Medicine. Blue Water Navy Veterans and Agent Orange Exposure. Washington, DC: The National Academies Press; 2011

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Responsible Party: Victoria J. Davey PhD, MPH, Senior Investigator, Epidemiology Program, Veteran Affairs Office of Patient Care Services
ClinicalTrials.gov Identifier: NCT02825602    
Other Study ID Numbers: 15-12
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Aggregate data will be available to investigators in accordance with VA access policy.
Keywords provided by Victoria J. Davey PhD, MPH, Veteran Affairs Office of Patient Care Services:
Vietnam veteran
aging
health
War Injury
Conventional Warfare
Toxic Effect
Chemical
Additional relevant MeSH terms:
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Combat Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders