ACTIVE Health: Relatively Healthy Male Veterans Observed Over Time to See What Types of Diseases Develop

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00076141
Collaborator
(none)
991
9
228
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Study Details

Study Description

Brief Summary

The purpose of this study is to gather a mixed racial group of relatively healthy male Veterans (for example, White, African-American, and Hispanic), who are at least 50 years of age. These men will be followed to see what types of diseases they develop and to determine if racial differences in lifestyle, blood test results, or genes are related to the types of diseases that are found. Diseases of particular interest are prostate cancer, other cancers, cardiovascular disease (for example, heart attacks and stroke), high blood pressure and diabetes. The group to be followed will consist of about 16,000 men recruited from about 40 VA Medical Centers across the country. Each man will be followed for at least five years depending on when he enters the study.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to gather a mixed racial group of relatively healthy male Veterans (for example, White, African-American, and Hispanic), who are at least 50 years of age. These men will be followed to see what types of diseases they develop and to determine if racial differences in lifestyle, blood test results, or genes are related to the types of diseases that are found. Diseases of particular interest are prostate cancer, other cancers, cardiovascular disease (for example, heart attacks and stroke), high blood pressure and diabetes. The group to be followed will consist of about 16,000 men recruited from about 40 VA Medical Centers across the country. Each man will be followed for at least five years depending on when he enters the study.

    Participants are asked to complete a set of forms to provide a brief medical history, demographics, information on lifestyle such as physical activities, smoking, and drinking, information on diet, and information on quality of life.

    Subjects will be seen on a biannual basis with follow-up telephone interviews conducted during the intervening years. Follow-up telephone interviews will be conducted at the MAVERIC Call Center while follow-up clinic visits will take place at each SELECT site. In addition, VA clinical and administrative databases will be used to augment follow-up and confirm reported events.

    During follow-up visits, participants will be asked whether they experienced any medical events since the last study visit, with information on specific diagnoses including prostate cancer, lung cancer, colon cancer, other cancers, stroke, myocardial infarction, hypertension, diabetes mellitus, kidney disease, chronic prostatitis, and benign prostatic hypertrophy. Confirmation of self-reported diagnosis will be made by an examination of discharge summaries, medical records, and available diagnostic and laboratory information by an end-points committee.

    Recruitment for this observational cohort will proceed in parallel with recruitment for SELECT and can use SELECT staff and resources with very little additional burden in cost or staff time.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    991 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    CSP #499A - Selenium and Vitamin E Cancer Prevention Trial - COHORT
    Actual Study Start Date :
    Jan 1, 2002
    Actual Primary Completion Date :
    Jan 1, 2014
    Actual Study Completion Date :
    Jan 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Older, Racially Diverse Males

    Racially Divers Males over 50, expected to live more than 5 years

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of Chronic Conditions in African American and White Male Veterans [Every six months for at least five years]

      To determine whether differences in the prevalence of common chronic conditions affecting older Veterans among African-American and white male Veterans are explained by medical, lifestyle, dietary, or other risk factors.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • relatively healthy male Veterans

    • at least 50 years old

    Exclusion Criteria:
    • Life expectancy of at least 5 yrs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA Medical Center, Loma Linda Loma Linda California United States 92357
    2 Edward Hines, Jr. VA Hospital Hines Illinois United States 60141-5000
    3 VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts United States 02130
    4 VA Medical Center, Minneapolis Minneapolis Minnesota United States 55417
    5 VA Medical Center, Kansas City MO Kansas City Missouri United States 64128
    6 VA Medical Center, Northport Northport New York United States 11768
    7 VA Medical Center, Syracuse Syracuse New York United States 13210
    8 James H. Quillen VA Medical Center Mountain Home Tennessee United States 37684
    9 VA Medical Center, Huntington Huntington West Virginia United States 25704

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Study Chair: Michael J Gaziano, MD MPH, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT00076141
    Other Study ID Numbers:
    • 499A
    First Posted:
    Jan 16, 2004
    Last Update Posted:
    Feb 1, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development

    Study Results

    No Results Posted as of Feb 1, 2021