Agricultural Health Study Follow-up

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01399411
First received: July 20, 2011
Last updated: June 20, 2014
Last verified: March 2014
  Purpose

Background:

- The Agricultural Health Study (AHS) is looking at the long-term health effects of farming exposures including pesticides, crops, and animals. The chronic health effects of exposure to pesticides are easier to study in farmers and their spouses. They know what chemicals they use and tend to live in the same place for most of their adult lives. AHS participants are expected to report any changes in their health. This includes any new medical conditions. Researchers want to follow up on these reports to confirm their accuracy.

Objectives:

- To follow up AHS participants who have self-reported that they have a new disease and confirm their diagnosis.

Eligibility:

- Current AHS participants.

Design:

  • Researchers will confirm self-reported changes in medical conditions by contacting the AHS participant to ask for more information.
  • The AHS participant will give permission for researchers to contact their doctor to look at their medical records. They will also be asked to provide a cheek swab or saliva sample.
  • Diseases of interest are rheumatoid arthritis, lupus, and Sjogren s Syndrome. Other diseases will be followed up in the future. Other diseases will be followed up in the future.

Condition
Rheumatoid Arthritis
Lupus Erythematosus, Systemic
Sjogren's Syndrome

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 89656
Study Start Date: June 2011
Detailed Description:

Pesticides are a common environmental exposure due to their widespread use for agricultural, residential, and public health purposes. Farmers and their families represent a unique population for studying the chronic health effects of pesticides because farmers know what chemicals they use, furthermore, farmers tend to remain at the same location over most of their adult life. The Agricultural Health Study (AHS), a cohort of ~89,000 pesticide applicators and spouses from Iowa and North Carolina, is the largest US cohort study of individuals working with pesticides. The AHS cohort was enrolled in 1993 to 1997 to assess human health effects associated with well characterized exposures to pesticides and other agricultural factors. Detailed exposure data were collected at enrollment and in two five-year follow-up interviews. As a result, the AHS has a wealth of information on pesticide use by both farmers and their spouses, as well as the ability to account for changes in pesticide use over time. Information on medical history and important covariates was also collected at enrollment and in the follow-up interviews, and will continue to be collected over time. Only mortality and cancer incidence are updated annually through linkage to vital statistics and cancer registries; all other health outcomes are based on self-reported information from participants. The accuracy of self-reported health outcome information can vary from quite good (e.g., asthma) to poor (e.g., rheumatoid arthritis). In order to ensure high quality epidemiologic analyses, validation of self-reported disease is necessary prior to statistical analysis. To date, several health endpoints have been validated through follow-up with AHS participants and their physicians. The purpose of the current protocol is three-fold: 1) update information on medical history and other important covariates through follow-up interviews of the cohort; 2) validate self-reported diseases among cohort participants over the duration of cohort follow-up (at least through 2020); and 3) complete initial contact of potential participants to inform them of other health outcome studies being conducted by an outside institution.

Currently, we plan to contact AHS cohort members to complete a follow-up interview allowing one of three modes of response: self-administered paper questionnaire, self-administered web survey (CAWI), and interviewer-administered telephone interview (CATI). We will contact proxy respondents if the participant is unable to provide information.

While the characteristics of the diseases may vary, the strategy for disease validation is similar. Validation efforts will include a phone call to the participant to confirm the self-report, a short questionnaire about disease characteristics, a request for permission to contact the participant s physician, and contacting the physician s office to obtain the relevant medical information. We may also collect a saliva or cheek swab sample from cases who confirm their self-reported disease to allow for future genetic and DNA analyses. These may include polymorphisms that influence disease susceptibility, response to xenobiotic agents, and innate immune response. We will contact proxy respondents if the participant is unable to provide information. Currently we plan to contact participants who have reported a history of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Sjogren s syndrome (SS). Over time, we plan to validate other diseases as they accrue in the cohort.

  Eligibility

Ages Eligible for Study:   24 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION AND EXCLUSION CRITERIA:

All members of the AHS cohort who were eligible for the Phase 3 interview will be eligible for the health follow-up. Individuals who only completed the enrollment questionnaire were excluded from Phase 3 eligibility. We will conduct the validation efforts under this protocol among all participants in the AHS. For individuals who are unable to provide information, we will allow a proxy to provide that information.

For the validation efforts, individuals who do not confirm diagnosis with diseases being validated will be excluded from further contact in that effort. For individuals who are unable to provide information over the phone, we will allow a proxy to provide that information. For specimen collection, we will ask the proxy respondent about whether the individual would be able to provide a sample. In order to obtain medical record release, we will allow the participant or their medical proxy to sign the form. For cases who are cognitively impaired or deceased, a medical proxy will be identified.

Determination of cognitive impairment will be made by report of proxy or by interviewer during conversation with participant. Because the AHS enrolled husband wife pairs, we should be able to identify an appropriate proxy for most participants.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399411

Contacts
Contact: Elizabeth L O'Connell (919) 287-4335 oconnelle@niehs.nih.gov
Contact: Dale Sandler, Ph.D. (919) 541-4668 sandler@niehs.nih.gov

Locations
United States, North Carolina
NIEHS, Research Triangle Park Recruiting
Research Triangle Park, North Carolina, United States, 27709
Contact: Elizabeth O'Connell    919-287-4335    oconnelle@niehs.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Dale Sandler, Ph.D. National Institute of Environmental Health Sciences (NIEHS)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01399411     History of Changes
Other Study ID Numbers: 999911196, 11-E-N196
Study First Received: July 20, 2011
Last Updated: June 20, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Self-Reported
Farming
Agriculture
Disease Validation
Autoimmune Disorders

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Sjogren's Syndrome
Arthritis
Autoimmune Diseases
Connective Tissue Diseases
Dry Eye Syndromes
Eye Diseases
Immune System Diseases
Joint Diseases
Lacrimal Apparatus Diseases
Mouth Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Xerostomia

ClinicalTrials.gov processed this record on October 21, 2014