Early Prediction of Aggressive COVID-19 Progression and Hospitalization
A hallmark of COVID-19 is its ability to get worse quickly and aggressively. While the 10 to 12 days after a positive COVID-19 test are when many patients are hospitalized, researchers do not understand what changes occur early in the disease and how they may predict hospitalization later. Additionally, while many patients recover within 14 days of symptom onset, the illness can take more than 25 days to resolve for some patients.
Mayo Clinic's Early Prediction of Aggressive Progression and Hospitalization study uses remote monitoring devices to help researchers understand how COVID-19 progresses and resolves.
The goal of the study is to gather vital sign and symptom data that will help the research team develop and verify an algorithm that predicts when an infection may suddenly or aggressively get worse in the future. The study team hopes that such an algorithm will allow for earlier treatment, identification of potential cutting-edge treatment opportunities or trials, and advanced planning of hospital resources, all of which are critical to minimizing disease impact and optimizing the clinical care of patients with COVID-19.
Your participation in this study is an important first step to helping researchers acquire the data necessary to develop this algorithm.
You are eligible to participate in this study if you:
- Are over the age of 18
- Have received a positive test for COVID-19 within the past 48 hours and can provide documentation of the test
- Are comfortable using and willing to interact with a tablet-based interface on a daily basis
You are not eligible to participate if you:
- Are under 18
- Tested positive for COVID-19 more than 48 hours prior to contacting study staff
- Are still waiting for a pending test for COVID-19
- Cannot confirm a positive test for COVID-19
- Are currently enrolled in a remote monitoring program via the Mayo Clinic Center for Connected Care
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. Throughout the 60-day study period, you'll wear a remote monitoring armband and use the tablet to answer a brief daily questionnaire about your symptoms and any anticipated or completed hospital visits.
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 COVID-19 and acquire the data needed to build a model that predicts disease severity in the future. This currently is not a 24/7 "lifelink" monitoring service. The study team does not give medical advice, but will remind you to seek medical care based on your symptoms. By participating in this study, you will help researchers gain a better understanding of COVID-19, but you will not receive direct benefits from remote monitoring.
Whether or not you visit a doctor or are hospitalized 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.
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.