Environmental Polymorphisms Registry Health and Exposures Survey

NCT ID: NCT01688986

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-25
• Study Completion Date: 2016-11-22

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.

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.

Conditions

Diabetes; Heart Disease; Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• ELIGIBILITY CRITERIA:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shepherd H Schurman, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Environmental Health Sciences (NIEHS)

Locations

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, United States

Countries

United States

References

Whitehead GS, Hussain S, Fannin R, Trempus CS, Innes CL, Schurman SH, Cook DN, Garantziotis S. TLR5 Activation Exacerbates Airway Inflammation in Asthma. Lung. 2020 Apr;198(2):289-298. doi: 10.1007/s00408-020-00337-2. Epub 2020 Feb 14.

Reference Type: DERIVED

PMID: 32060608 (View on PubMed)

Other Identifiers

12-E-0194

Identifier Type: -

Identifier Source: secondary_id

120194

Identifier Type: -

Identifier Source: org_study_id