Agricultural Health Study Follow-up (NCT01399411) | Clinical Trial Compass
CompletedNot Applicable
Agricultural Health Study Follow-up
United States89,656 participantsStarted 2011-07-05
Plain-language summary
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.
Who can participate
Age range
24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION AND EXCLUSION CRITERIA:
All members of the AHS cohort who were eligible for the Phase 3 interview were eligible for the Phase 4 health follow-up. We will apply the same eligibility criteria for future cohort-wide follow-ups. Individuals who only completed the enrollment questionnaire were excluded from Phase 3 eligibility. Depending upon the disease outcome of interest, we may conduct the disease confirmation and validation efforts under this protocol among all participants in the AHS who provided self-reported diagnoses at any interview (e.g. Baseline, or Phases 2-4). For individuals who are unable to participate, we will allow a proxy to provide the information.
For the validation efforts, individuals who do not confirm their diagnosis of interest (via self or proxy report) will not be asked to provide physician contact for medical records. For specimen collection, we will ask the proxy respondent about whether the individual would be able to provide a sample. In order to obtain MRR 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this Agricultural Health Study is a completed observational follow-up study rather than a treatment trial, how does participating in something like this — which involves interviews and health history updates rather than any new medication or procedure — fit into my overall care plan for asthma or Parkinson's disease?
2Because this study is focused on tracking and validating self-reported health information over time, rather than testing a treatment, would my doctor expect any direct medical benefit for me from being involved, or is the value mainly contributing to research on farming-related health risks?
3Since the study has already been completed, are there published findings from this Agricultural Health Study cohort that my doctor thinks are relevant to my specific diagnosis — particularly around agricultural exposures and conditions like Parkinson's disease or asthma?
4If I have a history of farming or pesticide exposure, would my doctor recommend any specific evaluations or monitoring based on what research like this has found about links between those exposures and Parkinson's disease or asthma?
5Are there active treatment trials or studies my doctor would recommend I look into instead of, or alongside, completed observational research like this one, given that my priority is finding options that could directly affect my health outcomes?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The purpose of the current protocol is three-fold: 1) update information on medical history and other important covariates through ongoing follow-up interviews of the cohort; 2) validate self-reported diseases among cohort participants over the ...
Timeframe: Various phases of follow-up; diseases are validated as they are ascertained
Trial details
NCT IDNCT01399411
SponsorNational Institute of Environmental Health Sciences (NIEHS)