TABLE 4.

Frequently asked questions (FAQ) document for patients, families, and SNF staff

Who is being asked to participate in this trial and why?	The study aims to enroll nursing home residents, not nursing homes themselves. COVID‐19 has had a disproportionate negative impact on older adults residing in nursing homes, who have historically been excluded from clinical trials and thus unable to fully benefit from medical advances. The research team is studying a promising therapy (Fisetin) that may help improve outcomes after COVID‐19 infection in nursing home residents.
What is Fisetin?	Fisetin is a substance with anti‐aging and anti‐inflammatory properties found in some fruits, vegetables, nuts, and wine. The dose being studied is much higher than that occurring in typical portions of these foods. Fisetin has shown benefit against the effects of viral infection in human cells and in an animal model of infection. It is administered orally as a pill or powder that can be mixed with food.
If I choose to participate, what will I need to do?	You will be randomly assigned to receive Fisetin or placebo, which you will take daily on days 0, 1, 8, and 9 of the study. You will not know which you are receiving. Mayo Clinic researchers will review your medical record frequently to check on your health status. Blood/urine collections will occur twice during the initial 14 days of the study, and if possible, at 3 months and 6 months after enrollment. You will not need to leave the nursing home—the research team will come to you.
How will I benefit from participating?	While it is not clear if receiving Fisetin after COVID‐19 infection will reduce your chance of dying or having worsening health, there is enough promising data from human cells and animals to suggest this is possible. If the trial is successful, and you are in the group assigned to receive Fisetin, your chance of dying or having worsening health after COVID‐19 infection may decrease. Even if this does not happen, you will be playing a role in advancing medical care for older adults living in nursing homes by helping accelerate new discoveries and treatments.
Who is conducting and paying for the trial?	The trial is conducted by Mayo Clinic researchers, funded by the National Institute on Aging (NIA)/National Institutes of Health (NIH), and approved by the NIA and Mayo Institutional Review Board (IRB).
Are there risks?	Fisetin is a naturally occurring substance found in many foods (though in much lower levels that used in this study). In other recent and ongoing clinical trials at Mayo Clinic, several dozen older adults have received Fisetin at the dose that will be used in this study. No substantial adverse effects have been seen. While there is no guarantee that side effects will not occur, the study team will be monitoring closely for these in real‐time.
What extra work will be required of SNF staff? How will the study drug be delivered and ordered?	We recognize that your staff are very busy and intend to avoid introducing extra work when residents in your facility are participating in the trial. The drug will be provided and delivered by the Mayo research pharmacy. It will be secured on site at your facility using storage provided by the research team. Your medical director will provide orders. A research team nurse will come to your facility to administer the drug, perform any needed assessments, and collect any samples when needed.

Note: This sample is for SNFs near Mayo Clinic. Similar forms will be used for SNFs near other Translational Geroscience Network institutions (Harvard [Hebrew SeniorLife], Johns Hopkins, and Wake Forest Universities, Universities of Connecticut, Michigan, and Minnesota, and University of Texas Health Sciences Center at San Antonio).