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Study Protocol
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
Fahad Mujtaba Iqbal
Imperial College London
Corresponding Author
ORCiD: https://orcid.org/0000-0003-0834-1275
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
The 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.
Methods
We 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.
Discussion
This 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 registration
ClinicalTrials.gov Identifier: NCT04337489
Keywords
remote sensing technology, protocol, clinical trial, patient deterioration, monitoring, ambulatory
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CURRENT STATUS: Under Review
Version 1
Posted 22 Sep, 2020
No community comments so far
Review #1 received
Received 01 Nov, 2020
Review #2 received
Received 28 Oct, 2020
Reviewer #3 agreed
On 25 Oct, 2020
Reviewer #2 agreed
On 22 Oct, 2020
Reviewer #1 agreed
On 20 Oct, 2020
Reviewers invited
Invitations sent on 20 Sep, 2020
Editor assigned
On 15 Sep, 2020
First submitted
On 14 Sep, 2020
Submission checks complete
On 14 Sep, 2020
Editor invited
On 14 Sep, 2020
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This preprint is under consideration at Pilot and Feasibility Studies. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study Protocol
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
Fahad Mujtaba Iqbal
Imperial College London
Corresponding Author
ORCiD: https://orcid.org/0000-0003-0834-1275
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 22 Sep, 2020
No community comments so far
Review #1 received
Received 01 Nov, 2020
Review #2 received
Received 28 Oct, 2020
Reviewer #3 agreed
On 25 Oct, 2020
Reviewer #2 agreed
On 22 Oct, 2020
Reviewer #1 agreed
On 20 Oct, 2020
Reviewers invited
Invitations sent on 20 Sep, 2020
Editor assigned
On 15 Sep, 2020
First submitted
On 14 Sep, 2020
Submission checks complete
On 14 Sep, 2020
Editor invited
On 14 Sep, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
The 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.
Methods
We 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.
Discussion
This 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 registration
ClinicalTrials.gov Identifier: NCT04337489
Figure 1
Figure 2