Early Detection of COVID-19 in High-Risk Workers

Remote monitoring: A potential trigger for early testing?

People on the front lines of the COVID-19 pandemic response — including health care workers, emergency services providers such as paramedics and police officers, and employees of essential businesses — are at higher risk of contracting the coronavirus. Furthermore, because most viral spread appears to occur during the asymptomatic stage, these front-line workers can unknowingly infect others before developing the symptoms that trigger testing under current guidelines.

Mayo Clinic's Generation of Algorithms that Enable Early Detection of Symptomatic SARS-CoV-2/COVID-19 Infection in High Risk Employees study remotely monitors people whose jobs put them at higher risk of contracting COVID-19. The ultimate goal of the study is to determine whether there are subtle, early indicators of health changes that are indicative of COVID-19 infection.

This study is the first step toward development of an algorithm that can recommend COVID-19 testing earlier — while people can spread the virus but before they've developed symptoms. Thus, while your participation in this study will help researchers gather the data to determine whether remote monitoring can detect infection earlier, you will not personally receive a direct medical benefit. Your participation may, however, help scientists develop algorithms that benefit other high-risk workers in the future.

Eligibility

You are eligible to participate in this study if you:

  • Are over the age of 18
  • Are employed 30 hours a week or more in a high-risk field with direct contact with patients or customers, including:
    • Health care — Physicians, respiratory therapists, nurses, dentists, allied health staff, custodial staff in health care systems, laboratory workers handling COVID-19 materials, morgue personnel and others with high potential for exposure to known or suspected sources of COVID-19
    • Emergency services — Police and sheriff's officers, state patrol, paramedics, emergency medicine technicians, and others with high potential for exposure to known or suspected sources of COVID-19
    • Critical service sectors — People in high-volume retail settings and others who have direct contact with the general public
    • Employees of essential businesses
  • Are comfortable using and willing to interact with a tablet-based interface on a daily basis
  • Have not experienced symptoms consistent with COVID-19 (as determined by the Mayo Clinic COVID-19 Self-Assessment Tool) within the past 30 days

You are not eligible to participate if you:

  • Are under the age of 18.
  • Have previously tested positive for COVID-19.
  • Are waiting for a pending test for COVID-19. You are only eligible after receiving negative results.
  • Are currently undergoing self-quarantine for suspected COVID-19. You are only eligible after receiving negative results.
  • Work fewer than 30 hours a week in a high-risk field.
  • Cannot clearly articulate the nature of patient or interpersonal interactions that place you at a higher risk.
  • Do not have direct, face-to-face interactions on a regular basis at work with people who may potentially be positive for COVID-19.
  • Are currently enrolled in remote patient monitoring via Mayo Clinic Center for Connected Care for any other health condition.
  • Have any of the following conditions:
    • Pacemaker implantation
    • Defibrillator implantation
    • Use of a neurostimulator
    • Bilateral axillary lymph node clearance

Procedure

If you are eligible and choose to enroll in the study, the study team will provide you with a remote monitoring kit and a tablet installed with the study application. For up to 60 days, you'll wear a remote monitoring armband, take lung function (spirometry) measurements, and use the tablet to answer a brief daily questionnaire about possible COVID-19 exposure, symptoms and testing. Then, the study team will continue to follow up with you once a month for the next three months.

During the initial 60-day period, you'll also have a brief, biweekly phone call with a study coordinator to confirm that the remote monitoring device is functioning as intended, that you're not having symptoms and that you haven't tested positive for COVID-19. If you do report symptoms or have a positive test, the study coordinator will advise you on next steps.

If your device detects specific triggers, it will send the study team an electronic notification to contact you to verify that the equipment is functioning properly and to remind you to document any changes in your symptoms on your tablet device.

The goal of the current study is to advance the understanding of what changes occur in the body during the earliest stage of COVID-19 infection and acquire the data needed to build a model that detects infection before obvious symptoms appear.

This currently is not a 24/7 "lifelink" monitoring service. The study team does not give medical advice, but the study team and daily tablet-based questionnaire will remind you to seek medical care if you start to show symptoms related to COVID-19 infection. You will not receive a direct benefit from remote monitoring by participating in this study. Your participation may, however, help researchers develop algorithms that benefit other high-risk workers in the future.

Whether or not you show symptoms or test positive for COVID-19 over the course of the study, all of your de-identified data will be uploaded to a secure cloud server, where it's analyzed by the study team and artificial intelligence tools.

Safety and privacy

Mayo Clinic is working with an external partner to provide equipment and support for this study. Both Mayo Clinic and its partner are committed to protecting the privacy and safety of participants, study personnel and the community. Mayo's external partner has undergone the same rigorous evaluation for safety and security as is used for current in-hospital devices.

Device safety

The study team uses stringent device processing and decontamination methods that meet or exceed both International Organization for Standardization and Food and Drug Administration guidelines for the decontamination of reusable medical devices. These preexisting decontamination strategies have already been shown to be effective at eliminating COVID-19.

Each kit is shipped in a specific medical bag to ensure the safety of participants, the study team, courier staff and staff employed by medical logistics partners.

Privacy and data security

All servers and data solutions used in this study meet or exceed stringent guidelines for HIPAA security.

After participants are identified as eligible for the study, they are assigned randomized and unique identifiers under which all subsequent data will be stored. Any information linking to patient data collected by Mayo Clinic study coordinators or staff will also be anonymized under these numbers.

Patient data are only sent to the cloud-based system when patients are in close proximity to the transmitter located within their homes. Thus, while storing data in the absence of the home-based hotspot, the device will not attempt to transmit data under unregistered or free-access Wi-Fi systems, further ensuring that participants' privacy is protected.