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

CSP #499A - Selenium and Vitamin E Cancer Prevention Trial - COHORT

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.

Study Overview

• Status: Completed
• Conditions: Healthy

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 Type: Observational
• Enrollment (Actual): 991

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92357
      • VA Medical Center, Loma Linda
  • Illinois
    • Hines, Illinois, United States, 60141-5000
      • Edward Hines, Jr. VA Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • VA Medical Center, Minneapolis
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • VA Medical Center, Kansas City MO
  • New York
    • Northport, New York, United States, 11768
      • VA Medical Center, Northport
    • Syracuse, New York, United States, 13210
      • VA Medical Center, Syracuse
  • Tennessee
    • Mountain Home, Tennessee, United States, 37684
      • James H. Quillen VA Medical Center
  • West Virginia
    • Huntington, West Virginia, United States, 25704
      • VA Medical Center, Huntington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

• relatively healthy male Veterans
• at least 50 years old

Description

Inclusion Criteria:

• relatively healthy male Veterans
• at least 50 years old

Exclusion Criteria:

• Life expectancy of at least 5 yrs

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Older, Racially Diverse Males; Racially Divers Males over 50, expected to live more than 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Chronic Conditions in African American and White Male Veterans	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.	Every six months for at least five years

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2002
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: January 14, 2004
• First Submitted That Met QC Criteria: January 15, 2004
• First Posted (Estimate): January 16, 2004

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: relatively healthy male
• Other Study ID Numbers: 499A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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