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Environmental Polymorphisms Registry Health and Exposures Survey

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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

9000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • North Carolina
      • Research Triangle Park, North Carolina, Forenede Stater
        • NIEHS Clinical Research Unit (CRU)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • ELIGIBILITY CRITERIA:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

25. august 2012

Studieafslutning

22. november 2016

Datoer for studieregistrering

Først indsendt

14. september 2012

Først indsendt, der opfyldte QC-kriterier

14. september 2012

Først opslået (Skøn)

20. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. august 2018

Sidst verificeret

22. november 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 120194
  • 12-E-0194

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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