Environmental Polymorphisms Registry Health and Exposures Survey

Sponsor
National Institute of Environmental Health Sciences (NIEHS) (NIH)
Overall Status
Completed
CT.gov ID
NCT01688986
Collaborator
(none)
9,000
1
50.9
176.7

Study Details

Study Description

Brief Summary

The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to gather health, family history of disease, environmental exposures and lifestyle data on adult EPR subjects. The EPR is a registry established to collect and store DNA samples from 20,000 volunteers from North Carolina and to serve as a resource to scientist investigating genotype-driven translational research of chronic conditions. Under this new protocol, we will administer a health and exposures survey to all EPR subjects. The information collected in the survey will be used to better characterize the EPR population thus making it more useful to NIEHS researchers. The survey contains approximately 200 questions. Data from the survey will help researchers develop hypotheses, design follow-up studies, and select appropriate subjects.

The survey will be administered to EPR subjects using a modified version of the Dillman Total Design Method (TDM) for surveys. This method requires following specific time-dependent steps for survey administration that incorporate both self- and phone administration and other types of phone and mail contact. The goal of TDM is to maximize subject response rates.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to collect health, family history of disease, environmental exposures and lifestyle data on EPR participants. The EPR was established to collect and store DNA specimens from 20,000 participants and to serve as a resource for scientists investigating genotype-driven translational research of chronic health conditions. Under this protocol, we will administer the approximately 200 question Health and Exposure Survey to EPR participants. The information will be used to better characterize the EPR population, thus making it more useful in answering research questions related to gene-environment interactions. Data from the survey will help researchers to advance clinical research by developing new ways of preventing, diagnosing, and treating common diseases such as cardiovascular disease, asthma, and diabetes.

    During Phases I and II, the survey was administered to EPR participants using a modified version of the Dillman Total Design Method (TDM) for surveys. This method requires following specific steps for survey administration that incorporate web-based, paper and phone administration. The rationale for using the TDM is to maximize participant response rates. During Phase III, the survey may be distributed to new EPR participants (e.g., those who were not enrolled in the EPR at the time of the Phase I and II survey administrations) for self-administration at the time of enrollment.

    Investigators may select and contact participants for follow-up studies based upon health, exposure, or disease status information; this includes responses to the EPR Health and Exposure Survey. Participation in follow-up studies is completely voluntary. Participants can decide at the time they are contacted if they would like to enroll in the follow-up study. Their decision whether or not to participate in a follow-up study will not affect their participation in the EPR.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Environmental Polymorphisms Registry Health and Exposures Survey
    Study Start Date :
    Aug 25, 2012
    Study Completion Date :
    Nov 22, 2016

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      • ELIGIBILITY CRITERIA:

      There are no clinical exclusion criteria for this Survey. All subjects will be administered the Survey regardless of having clinical conditions.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 NIEHS Clinical Research Unit (CRU) Research Triangle Park North Carolina United States

      Sponsors and Collaborators

      • National Institute of Environmental Health Sciences (NIEHS)

      Investigators

      • Principal Investigator: Shepherd H Schurman, M.D., National Institute of Environmental Health Sciences (NIEHS)

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      National Institute of Environmental Health Sciences (NIEHS)
      ClinicalTrials.gov Identifier:
      NCT01688986
      Other Study ID Numbers:
      • 120194
      • 12-E-0194
      First Posted:
      Sep 20, 2012
      Last Update Posted:
      Aug 31, 2018
      Last Verified:
      Nov 22, 2016
      Keywords provided by National Institute of Environmental Health Sciences (NIEHS)
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Aug 31, 2018