Design of the Pilot, Proof of Concept REMOTE-COVID Trial: Remote Monitoring Use in Suspected Cases of COVID-19 (SARS-CoV 2) A Trial Protocol

Abstract

BackgroundThe outbreak of SARS-CoV-2 (coronavirus, COVID-19), declared a pandemic by the World Health Organisation (WHO) is global health problem with ever-increasing attributed deaths. Vital sign trends are routinely used to monitor patients with changes in these parameters often preceding an adverse event. Wearable sensors can measure vital signs continuously (e.g. heart rate, respiratory rate, temperature) remotely and can be utilised to recognise early clinical deterioration. MethodsWe describe the protocol for a pilot, proof-of-concept, observational study to be conducted in an engineered hotel near London airports, United Kingdom. The study is set to continue for the duration of the pandemic. Individuals arriving to London with mild symptoms suggestive of COVID-19 or returning from high risk areas requiring quarantine, as recommended by Public Health England, or healthcare professionals with symptoms suggestive of COVID-19 unable to isolate at home will be eligible for a wearable patch to be applied for the duration of their stay. Notifications will be generated should deterioration be detected through the sensor and displayed on a central monitoring hub viewed by nursing staff, allowing for trend deterioration to be noted. The primary objective is to determine the feasibility of remote monitoring systems in detecting clinical deterioration for quarantined individuals in a hotel. DiscussionThis trial should prove the feasibility of a rapidly implemented model of healthcare delivery through remote monitoring during a global pandemic at a hotel, acting as an extension to a healthcare trust. Potential benefits would include reducing infection risk of COVID-19 to healthcare staff, with earlier recognition of clinical deterioration through ambulatory, continuous, remote monitoring using a discrete wearable sensor. We hope our results can power future, robust future randomised trials.Trial registrationClinicalTrials.gov Identifier: NCT04337489

The pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV 2)

“…This pragmatically designed, observational, unblinded, pilot and feasibility study was conducted in hotels nearby London airports from May 2020 to June 2020. A detailed protocol has been published [ 11 ]. Briefly, returning travellers into London airports or healthcare staff who were suspected of having COVID-19 and were unable to isolate, were recruited into hotels for isolation, and eligible for the study.…”

“…All alerts were viewed by dedicated trained nurses at a central monitoring hub, providing continuous, on-site cover at the hotel. Alert transmissions were generated when predefined alarm thresholds for vital parameters were crossed [ 11 ].…”

A survey of COVID-19 detection and prediction approaches using mobile devices, AI, and telemedicine

“…As a result, there has been a body of research conducted on the application of telemedicine for remote prediction and consultation of COVID-19 using IoT medical devices (Ohannessian et al, 2020;Kocsisné and Attila, 2021). Many examples of the technologies to monitor patients and detect COVID-19 early are based on the uses of traditional smart medical sensors that measure the patients' pulse, thermal information, and blood oxygen level (Elagan et al, 2021;Iqbal et al, 2021). Jiang et al analyzed existing wearable devices and proposed a wearable tele-health solution for monitoring a set of physiological parameters that are critical for COVID-19 patients.…”