Artificial intelligence mobile health platform for early detection of COVID-19 in quarantine subjects using a wearable biosensor: protocol for a randomised controlled trial

• Published in: BMJ open 2020-07, Vol.10 (7), p.e038555-e038555
• Main Authors: Wong, Chun Ka, Ho, Deborah Tip Yin, Tam, Anthony Raymond, Zhou, Mi, LAU, Yuk Ming, Tang, Milky Oi Yan, Tong, Raymond Cheuk Fung, Rajput, Kuldeep Singh, Chen, Gengbo, Chan, Soon Chee, SIU, Chung Wah, Hung, Ivan Fan Ngai
• Format: Article
• Language: English
• Subjects: Artificial Intelligence; Asymptomatic; Betacoronavirus; Biosensors; Blood Gas Monitoring, Transcutaneous; Body temperature; Clinical Laboratory Techniques; Clinical trials; Cloud Computing; Coronavirus Infections - diagnosis; Coronavirus Infections - physiopathology; Coronaviruses; COVID-19; COVID-19 Testing; Data collection; Early Diagnosis; Epidemics; Fever; Health surveillance; Heart Rate; Hong Kong; Humans; Infections; Infectious Diseases; Intervention; Machine learning; Mobile Applications; Oxygen saturation; Pandemics; Physiology; Pneumonia; Pneumonia, Viral - diagnosis; Pneumonia, Viral - physiopathology; Public health; Quarantine; Randomized Controlled Trials as Topic; Respiratory Rate; Sample size; SARS-CoV-2; Skin; Skin Temperature; Smartphone; Smartphones; Telemedicine; Wearable Electronic Devices
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2020-038555

IntroductionThere is an outbreak of COVID-19 worldwide. As there is no effective therapy or vaccine yet, rigorous implementation of traditional public health measures such as isolation and quarantine remains the most effective tool to control the outbreak. When an asymptomatic individual with COVID-19 exposure is being quarantined, it is necessary to perform temperature and symptom surveillance. As such surveillance is intermittent in nature and highly dependent on self-discipline, it has limited effectiveness. Advances in biosensor technologies made it possible to continuously monitor physiological parameters using wearable biosensors with a variety of form factors.ObjectiveTo explore the potential of using wearable biosensors to continuously monitor multidimensional physiological parameters for early detection of COVID-19 clinical progression.MethodThis randomised controlled open-labelled trial will involve 200–1000 asymptomatic subjects with close COVID-19 contact under mandatory quarantine at designated facilities in Hong Kong. Subjects will be randomised to receive a remote monitoring strategy (intervention group) or standard strategy (control group) in a 1:1 ratio during the 14 day-quarantine period. In addition to fever and symptom surveillance in the control group, subjects in the intervention group will wear wearable biosensors on their arms to continuously monitor skin temperature, respiratory rate, blood pressure, pulse rate, blood oxygen saturation and daily activities. These physiological parameters will be transferred in real time to a smartphone application called Biovitals Sentinel. These data will then be processed using a cloud-based multivariate physiology analytics engine called Biovitals to detect subtle physiological changes. The results will be displayed on a web-based dashboard for clinicians’ review. The primary outcome is the time to diagnosis of COVID-19.Ethics and disseminationEthical approval has been obtained from institutional review boards at the study sites. Results will be published in peer-reviewed journals.