Contract research organization PRA Health has launched a new mobile app aimed at tracking patients’ physical and psychological symptoms from COVID-19.
The new app, the CRO explains, allows employers, payers, providers and health systems to track the “health and wellbeing of individuals” who may not be suffering from the full force of the disease (i.e., are asymptomatic) and/or are exposed or diagnosed with COVID-19 during the pandemic.
It’s a “three-tiered” approach, according to PRA, and works like this: The company looks at an individual’s COVID-19 disease status and then tags them into one of three groups:
- The educational program, which provides vital sign tracking, prevention techniques and mental health support for those who are asymptomatic.
- The quarantine program, which delivers insights on what to watch for, addresses feelings of fear and isolation and connects with a healthcare professional for those who have been exposed to COVID-19.
- The in-depth monitoring program, which addresses symptom management and includes frequent monitoring by a healthcare professional and care coordination for those who have been diagnosed with COVID-19 and who are still at home.
This can also help the CRO, which runs trials for biopharma companies (and also has a major R&D deal with Takeda, which is working on a plasma therapy using recovered patients’ blood), collect data from patients including body temperature, heart rate and pulse oximetry.
It can also add other symptoms like shortness of breath, fatigue and changes in coughing.
Kent Thoelke, executive vice president and chief scientific officer at PRA, gave FierceCRO more details on just how the app will work in practice. In terms of the data collected, Thoelke said PRA will be using these to “generate insights” for the nursing staff in the clinical call center. Here, nurses can advise and educate users on vital signs interpretation and prevention techniques as well as address other concerns such as mental health issues, he said.
Data will be encrypted and stored in a Microsoft Azure-based, secure, HIPAA-compliant cloud environment, but will not be de-identified for the nurses monitoring the users.
I asked whether PRA will be using any of the data they collect for internal or external purposes. Thoelke said: “While the data from the COVID-19 programs will remain specific to those users, remote monitoring can be an important capability in accelerating new trials. By gathering data remotely and supporting virtual clinic trials, new trials may be able to limit the exposure of healthcare professionals and conserve important resources like masks.”
You won’t find this app on Apple Store or Google: It’s specifically set up for healthcare organizations and large employers, and the company said it is in discussions with academic institutions, governmental organizations, health departments and other private businesses to roll out the program. “If you’re an employee with an employer who wants to roll this app out, you will get an email to register online and be invited to download the app,” Thoelke explained.
People will take their own temperatures—one of the key determining factors for COVID-19 at this point, Thoelke says—and input the data. PRA also provides kits with tablets, pulse oximetry, spirometry and other vital signs capture as appropriate for the isolation program.
PRA isn’t asking people to confirm they have the disease, however: “No, one does not need to have a confirmed cased of COVID-19 to be able to use the app,” but rather assigned to the aforementioned three-tier system.