Iqbal et al. BMC Public Health
(2021) 21:638
https://doi.org/10.1186/s12889-021-10660-9
RESEARCH ARTICLE
Open Access
The pilot, proof of concept REMOTE-COVID
trial: remote monitoring use in suspected
cases of COVID-19 (SARS-CoV 2)
Fahad Mujtaba Iqbal1*, Meera Joshi1, Gary Davies2, Sadia Khan2, Hutan Ashrafian1 and Ara Darzi1
Abstract
Background: SARS-CoV-2 has ever-increasing attributed deaths. Vital sign trends are routinely used to monitor
patients with changes in these parameters preceding an adverse event. Wearable sensors can measure vital signs
continuously and remotely, outside of hospital facilities, recognising early clinical deterioration. We aim to
determine the feasibility & acceptability of remote monitoring systems for quarantined individuals in a hotel
suspected of COVID-19.
Methods: A pilot, proof-of-concept, feasibility trial was conducted in engineered hotels near London airports (May–
June 2020). Individuals arriving to London with mild suspected COVID-19 symptoms requiring quarantine, as
recommended by Public Health England, or healthcare professionals with COVID-19 symptoms unable to isolate at
home were eligible. The SensiumVitals™ patch, measuring temperature, heart & respiratory rates, was applied on
arrival for the duration of their stay. Alerts were generated when pre-established thresholds were breeched; trained
nursing staff could consequently intervene.
Results: Fourteen individuals (M = 7, F = 7) were recruited; the mean age was 34.9 (SD 11) years. Mean length of
stay was 3 (SD 1.8) days. In total, 10 vital alerts were generated across 4 participants, resulting in telephone contact,
reassurance, or adjustment of the sensor. No individuals required hospitalisation or virtual general practitioner
review.
Discussion: This proof-of-concept trial demonstrated the feasibility of a rapidly implemented model of healthcare
delivery through remote monitoring during a pandemic at a hotel, acting as an extension to a healthcare trust.
Benefits included reduced viral exposure to healthcare staff, with recognition of clinical deterioration through
ambulatory, continuous, remote monitoring using a discrete wearable sensor.
Conclusion: Remote monitoring systems can be applied to hotels to deliver healthcare safely in individuals
suspected of COVID-19. Further work is required to evaluate this model on a larger scale.
Trial registration: Clinical trials registration information: ClinicalTrials.gov Identifier: NCT04337489 (07/04/2020).
Keywords: Remote sensing technology, Clinical trial, Patient deterioration, Monitoring, ambulatory
* Correspondence: fahad.iqbal@doctors.org.uk
The trial protocol is published and available here: https://doi.org/10.1186/
s40814-021-00804-4.
1
Division of Surgery & Cancer, 10th Floor Queen Elizabeth the Queen Mother
Wing (QEQM) St Mary’s Campus, London W2 1NY, UK
Full list of author information is available at the end of the article
© The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,
which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give
appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if
changes were made. The images or other third party material in this article are included in the article's Creative Commons
licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons
licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain
permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the
data made available in this article, unless otherwise stated in a credit line to the data.
Iqbal et al. BMC Public Health
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Background
The outbreak of SARS-CoV-2 (COVID-19), declared a
pandemic by the World Health Organisation (WHO)
and a growing global health problem, has stretched resources, creating pressures within the National Health
Service (NHS) with implications for patient safety [1].
In accordance with Public Health England recommendations, a period of isolation may be required for a time
duration [2]. The rate of clinical deterioration for individuals suffering from COVID-19 remains unknown;
given that widespread vaccine deployment remains imminently unforeseeable, novel strategies are required in
approaching this pandemic.
Vital signs trends (heart rate, respiratory rate, blood
pressure, temperature, oxygen saturations) are routinely
used for monitoring hospital patients [3]. Clinical deterioration may be recognised through changes in these parameters, with prodromal changes preceding an adverse
event [4, 5]. Consequently, the National Institute for
Health and Care Excellence (NICE) and the Royal College of Physicians (RCP) recommend that all patients
have their vital signs recorded every 12 h as a minimum
[6, 7].
Across the National Health Service (NHS), the use of
the National Early Warning Score 2 (NEWS), a ‘track
and trigger’ warning score, has been implemented in accordance with the RCP to guide on escalation protocols
and monitoring frequency of vital signs [7]. Accordingly,
heart rate (HR), respiratory rate (RR), temperature,
blood pressure, oxygen saturation, and level of consciousness are assessed every 4–6 h with more frequent
monitoring for acutely unwell patients.
Advances in digital technologies have renewed promise for remote monitoring solutions [8, 9]. Wearable sensors and alerting systems can continuously remotely
monitor vital parameters, recognising early deterioration
and supporting clinical decision making. As such, allowing individuals to receive care outside of expensive hospital facilities; in resource limited hospitals; and in
alternate sites during crises [10].
Delivery of healthcare outside of hospital facilities (e.g.
in hotels) is theoretically possible through continuous
remote monitoring of vital signs but has yet to be studied; given the global pandemic and fear of future waves,
assessment of its viability is justified. As such, the aim of
this study was to evaluate the practicality of the SensiumVitals™ system in delivering healthcare in a hotel,
acting as an extension to a healthcare trust for individuals suspected of coronavirus. This pilot was performed
to determine the feasibility of implementing this system
to support future studies, with a focus on wearability,
data usability, and safety. This will inform a further definitive trial, optimising recruitment, and follow-up
protocols.
Methods
Study design
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. Exclusion criteria included the
presence of a pacemaker, skin reaction to the wearable
patch, and consent withdrawal.
The duration of isolation varied, in accordance with
changing government guidelines, swab results, and
symptomatology. These individuals were assessed by
healthcare professionals, swabbed if necessary, and fitted
with a wearable patch before being securely transferred
to their rooms. A central monitoring hub was established to monitor the recorded parameters by the
National Health Service (NHS) healthcare staff from a
local Trust. The hub consisted of a site manager, porters, security staff, nurses, ambulance services, professional cleaners, and hotel staff.
All participants provided informed consent and were
followed for the duration of their stay. Ethical approval
for this study was granted by the Research Ethics Committee (IRAS: 281757). The trial was performed in accordance with Good Clinical Practice guidelines and the
Declaration of Helsinki. Patient data was anonymised to
ensure privacy. Storage and handling of personal data
complied with the General Data Protection Regulation.
Wearable sensor and alerts
SensiumVitals™ have produced a disposable, lightweight,
waterproof, wearable wireless ‘patch’ which attaches to a
participant’s chest with two adhesive ECG electrodes
and records HR, RR and axillary temperature every
2 min, transmitting the data to a central monitoring
hub, viewable through a secured web-browser, through
radiofrequency and dedicated intranet hotspots (bridges)
installed in hotel rooms (Fig. 1). This provided continuous monitoring for individuals at the hotel. It is a low
powered device with a battery life of 5 days.
RR was recorded using principles of impedance
pneumography and HR through single-lead ECG. A
temperature-sensitive resistor is placed in the axilla for
readings. Once a physiological signal is acquired, it is
processed by embedded algorithms within the sensor to
ensure noisy or irregular signals are not reported, reducing false alerts.
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
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Fig. 1 SensiumVitals monitoring system; permission granted to use image by SensiumVitals
when predefined alarm thresholds for vital parameters
were crossed [11].
Intervention protocol for alerts
All incoming alerts were deemed to be of potential clinical relevance and resulted in a phone contact between
the interpreting nurse and the participant; each hotel
room had installed landlines. This allowed for additional
question seeking at the discretion of the health care
worker to gain insight. Potential outcomes included administration of analgesia, general education and anxiety
management, virtual GP review, or escalation to the hospital. These actions were protocol driven.
Outcome measures
The total number of alerts, proportion of actioned alerts,
and resultant actions (i.e. phone consultation, virtual
general practitioner review, transfer to hospital) were
measured.
To understand the acceptability and usability of the
SensiumVitals™ system by participants and healthcare
staff, mixed methods consisting of semi-structured interviews and questionnaires were utilised. For participants,
these were completed at the end of their isolation; for
healthcare staff, they were conducted once familiarity
with the system was established. The questionnaires
consisted of five-point Likert scale responses (strongly
disagree to strongly agree), with elements adapted from
the validated System Usability Scale (supplementary material) [12]. Semi-structured interviews, conducted using
prepared topic guides, were recorded, anonymised, and
transcribed verbatim before entered in to NVivo 12 for
analysis (supplementary material). Topics covered included comfort, understanding, safety, and repeated use.
Statistical analysis
Descriptive statistics were used to describe baseline
characteristics of participants, alerting frequencies, and
events.
A mixed methods analysis was undertaken for questionnaire and semi-structured interview data. Frequency
distributions were generated for Likert scale responses.
Interview transcripts were analysed using Braun and
Clarke’s thematic analysis [13]. In brief, the transcripts
were independently studied by two researchers, evaluating for common attitudes and experiences between participants. Emergent themes were coded with data
systematically reviewed to ensure the identified themes
were suitable. Facilitators and barriers were ascertained
from healthcare staff [14, 15].
Results
Study population
A total of 15 participants were eligible for the study: of
which, one refused study participation stating anxiety as
a reason. The remaining were enrolled into the study
(Fig. 2, N = 14). Baseline demographics are presented in
Table 1. The mean length of stay at the hotel was 3.1
(SD: 1.8) days.
Clinical events
During the study, a total of 10 vital alerts were received
across four individuals (Table 2). Two alerts were unactioned (for abnormal respiratory rates) and expired.
None of the recruited individuals required hospitalisation or virtual general practitioner review. Two individuals developed a skin reaction to the adhesive (tape or
ECG electrodes) but continued to participate in the
study. There were no dropouts in our study.
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Fig. 2 Participant flow diagram
Healthcare and participant perceptions
Participant perceptions
Nine participants responded to questionnaires and
four participated in semi-structured interviews. Overall, guests perceived the sensor to be comfortable,
felt safer with its use, and would wear the sensor
again; very few found it to be complicated. Frequency distribution of participant responses are
shown in Fig. 3.
Table 1 Baseline characteristics
Characteristics (N = 14)
N (%)
Age (years), mean (SD)
34.9 (11.0)
Male
7 (50)
Female
7 (50)
Caucasian
7 (50)
BAME
7 (50)
SARS-CoV 2 swab positive
3 (21.4)
Co-morbidity:
• None
6 (42.9)
• Asthma
3 (21.4)
• Cardiovascular (e.g. hypertension)
2 (14.3)
• Neurological (e.g. migraine, seizures)
2 (14.3)
• Anxiety/depression
2 (14.3)
BAME British, Asian, Minority Ethnic
Four main themes emerged from the interviews: i)
functionality; ii) comfort and usability; iii) sense of security; and iv) privacy.
Functionality
Overall, participants were aware of the purpose of monitoring and the miniturisation of the sensor was
appealing.
“ … monitor you remotely from the [central monitoring] station … something that’s an alteration or a
shift [in your vital signs], [the nurses] can then contact us and see how we’re feeling and if it matches
[the vital sign readings] … you can’t really see [the
sensor through] the clothes. It’s quite small … you
can’t see it” (guest 1)
“it was not heavy at all.” (guest 2)
One obvious advantage was the reduction in viral exposure to healthcare staff and this was reflected by
participants.
“you can have limited contact to patients, especially
if the patient is infectious. I’d say that you can
monitor the patient [without] having frequent contact … so it’s good.” (guest 2)
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Table 2 Clinical events following alerts
Events
Alert
Management
10 vital alerts in 4 patients
Abnormal temperature reading (1 episode)
Anti-pyretic (paracetamol) administered following telephone
consultation (1 episode)
Abnormal respiratory rate reading (9 episodes)
No action taken following telephone review (6 episodes)
Electrodes reapplied (1 episode)
Comfort and usability
Most guests reported the sensor as comfortable to wear
in the questionnaire. However, an initial period may be
required to be accustomed to the sensor.
“I took it off [before] I had my shower … I would
have probably been a bit reluctant to shower in it.”
(guest 3)
Sense of security
“it’s not really that uncomfortable … I got used to it
over time. It’s just about adjusting to it the first time
I wore it.” (guest 2)
Guests reported mixed experiences on the practicalities of wearing the sensor with their daily activities.
“I tended not to sleep on my side as I thought it
might come off. It wasn’t particularly restrictive
[otherwise]. (guest 3)
“when I shower I’m always very cautious to wash
around it.” (guest 1)
Participants felt comforted and secure knowing they
were receiving continuous monitoring remotely.
“I felt, to be honest, probably a bit more comfortable that somebody’s keeping an eye on things …
things can deteriorate quickly.“ (guest 3)
“I feel secure and I felt safe being there, being monitored” (guest 2)
“It felt good. It gave me a little bit more of a sense
of being monitored and cared for.” (guest 4)
Privacy
“I think the tape [to fasten the temperature wire]
was a little bit [inconvenient] but not the actual
wire” (guest 3)
“At first it was difficult to adjust [to]. It was like it felt
a bit tight, I mean the tape on my underarm was a bit
tight … also I did wonder the probe to lose contact
with my skin, because I wanted the monitoring to be
precise. And so I was always worried about losing
contact with the probe on my skin … over time it was
comfortable … I got used to it over time … washing
or sleeping wasn’t a problem” (guest 4)
Fig. 3 frequency distribution of participant questionnaire responses
None of the guests felt their privacy was invaded
through sensor use.
“it’s not too intrusive of what my activities are”
(guest 1)
Healthcare staff perceptions
A total of six staff members responded to the questionnaire and participated in semi-structured interviews.
The hotel model of healthcare provision was perceived
with mixed feedback amongst nursing staff. However,
most staff felt that the technology was trustworthy, not
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burdensome, and delivered an improved level of care because of wearable sensors and digital alerting. Frequency
distribution responses are shown in Fig. 4.
Two main themes emerged from the interviews
which were sub-categorised into facilitators and barriers: i) factors relating to the sensor and ii) perceived
usefulness.
Factors relating to the sensor
Facilitators Overall, healthcare nurses favoured the dimensions of the sensor and the simplicity of the system.
“It was quite compact, quite small. Easy to apply”
(nurse 6)
“portability … the individual patients/guests are not
restricted in their movements … [the system] was
quite intuitive and quite easy” (nurse 2)
“person doesn’t seem to know they’re wearing it, so
that’s good” (nurse 3)
“I’m quite surprised actually that they could carry
on with the routine activities, even shower with it,
without having to remove it and reapply it which I
thought was fantastic … . I think the guests liked it
too. I know one guy who came, a young gentleman,
he was really glad that we were monitoring him”
(nurse 6)
Barriers Adhesive tapes and electrodes were noted to
have varying efficacy amongst different guests, affecting
overall signal quality. This required repeated fastening
and replacement in some cases.
Fig. 4 frequency distribution of healthcare questionnaire responses
“we had one person who the electrodes kept popping off so that might be something [that needs] improving.” (nurse 2)
“I think a weakness was the temperature probe.”
(nurse 4)
“There are one or two guests that the readings were
not coming out as we would have liked. And it could
be because they were moving very fast or they have
removed [the sensor] from its position.” (nurse 5)
Perceived usefulness
Facilitators The system was perceived as providing a
clinical insight by healthcare staff whilst reducing viral
exposure.
“I think for our group of patients it’s been really
good. Because they’re behind a closed door it has
given us an opening to see what else is going on”
(nurse 3)
“It’s quite beneficial. It saves time and if the machine
is accurate and that it will trigger any intervention if
necessary and I think it’s a good thing.” (nurse 5)
“gave me additional reassurance that we knew
exactly what was going on” (nurse 6)
“easier to sort of escalate if people needed further
treatment quickly” (nurse 1)
“I think staff exposure [to coronavirus] was reduced” (nurse 6)
Iqbal et al. BMC Public Health
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“it gives them [nurses] time to be able to do other
things with them.” (nurse 3)
Barriers Nurses reported the need for trained staff to
action alerts and, for some individuals, may be a source
of anxiety.
“that is a safety issue, people need to know how to
use things properly, how to escalate the information
it’s providing them with properly because to not use
it puts the patient at risk.” (nurse 2)
“You still need sort of trained staff to understand
what it all means so you wouldn’t be able to run it
here with a healthcare assistant or with no nurses,
you’d need to have a healthcare professional that
was experienced here.” (nurse 1)
“there may be some patients where mental health
may be the dominant thing that you’re trying to
treat … wearing this patch may feed into a paranoia
or a confusion or something like that.” (nurse 2)
Discussion
This trial demonstrated feasibility and proof of concept
of a rapidly implemented model of healthcare delivery
through remote monitoring during the first wave of
COVID-19 whereby hotels acted as an extension to a
healthcare trust. Digital alerts generated when preestablished thresholds were breeched allowed for healthcare professionals to interpret and respond successfully.
This study also provided a broad overview of participant
and healthcare staff perceptions on digital alerting and
sensor use in a remote monitoring context. Although
previous work has explored patient attitudes of sensor
use in hospital settings, healthcare staff perceptions were
not described and remote monitoring significantly alters
the delivery of healthcare, a model which undergoes further evolution during a pandemic [16, 17].
Although a proportion of generated alerts resulted in
clinical action, no individuals in our cohort required virtual GP review or hospitalisation. Given our small sample size and limited duration of stay at the hotel, the
potential benefits of digital alerting systems and continuous remote monitoring may have been underestimated.
However, our cohort was relatively young with few comorbidities, representing a low potential to require
escalation for hospital care. Nonetheless, given the exploratory nature of the trial, feasibility was demonstrated
with the clinical events observed and no dropouts.
Previous work has shown acceptability and practicability of continuous monitoring using wearable sensors on
general surgical and medical wards [18, 19]. Initial work
Page 7 of 8
by Downey et al. which also tested the same sensor (SensiumVitals™) were limited by imbalanced randomisation
across the two trial arms [18]. Nonetheless, the trials
demonstrated feasibility in hospital settings. Barriers and
facilitators of implementing wearable sensor based continuous monitoring were conducted on a surgical cohort
which similarly identified the importance of design,
comfort, and safety; semi-structured interviews for patients and healthcare staff, favoured the notion of continuous vital sign monitoring in general wards [19]. It
should be noted that many of the patients interviewed
were admitted for malignant disease which is likely to
influence qualitative perceptions. Moreover, practicality
of these systems utilised in hospital care is vastly different to a remote & community healthcare model. Our
work identified additional perceptions in remote sensing
environments.
Pre-pandemic, prominent global health leaders and societies have focused on delivering ‘high-value care’. The
American College of Physicians (ACP), the Society of
Hospital Medicine (SHM), Royal College of Physicians
(RCP), Royal College of General Practitioners (RCGP),
and leaders in the field of medicine advocated the use of
high-value care [20–22]. This dictates a judicious use of
resources while providing the best possible care. With
the scarcity of resources in the current pandemic, our
study can envisage potential future implications.
Despite the strengths of our study, the design presents
inherent limitations. To maximise capacity at the hotel
given the unknown of the pandemic, a pragmatic, observational design was favoured; randomisation was not
deemed appropriate. Government restrictions rapidly
underwent changes for air travel and isolation guidelines, which significantly altered our sample size and
duration of isolation. Moreover, the inclusion of healthcare staff who wore the sensor, are inherently familiar
with vital signs and clinical observations; this may bias
the description of favourable experiences. However, such
individuals are also likely to carry greater expectations.
As such, their inclusion is unlikely to affect the demonstration of proof of principle. Device specific outcomes,
such as the varying efficacy of adhesive tapes and electrodes, lack generalisability when compared to other
available sensors but provide a broad insight into design
considerations.
In conclusion, feasibility of remote sensing was demonstrated in our trial and favourable experiences described
by healthcare staff and participants. Wearable sensors providing continuous monitoring may facilitate predictive
modelling for deterioration and early interventions in remote & community settings. Further work should explore
the effect of remote sensing and its impact on clinical outcomes, particularly given the evolving model of healthcare
delivery, accelerated by the pandemic.
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Supplementary Information
4.
The online version contains supplementary material available at https://doi.
org/10.1186/s12889-021-10660-9.
5.
Additional file 1.
Acknowledgements
Infrastructure support for this research was provided by the NIHR Imperial
Biomedical Research Centre (BRC) and the NIHR Imperial Patient Safety
Translational Research Centre (PSTRC). The authors would like to thank all the
staff at the hotel sites with particular mention to Stephanie StevensonShand, who played a lead role in assisting with day to day logistical issues.
6.
7.
8.
Authors’ contributions
FMI drafted the manuscript and performed the quantitative analysis. FMI and
MJ performed thematic analyses independently with disagreements resolved
through consensus. MJ, GD, SK, HA, and AD all contributed to significant
amendments to the final manuscript. The author(s) read and approved the
final manuscript.
9.
10.
Funding
This work was supported by a grant provided through CW+ (the official
charity of Chelsea and Westminster Hospital). The funding body played no
role in the design of the study and collection, analysis, and interpretation of
data and in writing this manuscript.
Availability of data and materials
The datasets generated during and/or analysed during the current study are
available from the corresponding author on reasonable request.
Declarations
Ethics approval and consent to participate
Ethical approval was obtained by the London – Queen Square Research
Ethics Committee (IRAS: 281757). All participants provided informed consent
to participate. The trial was performed in accordance with Good Clinical
Practice guidelines and the Declaration of Helsinki. Patient data was
anonymised to ensure privacy. Storage and handling of personal data
complied with the General Data Protection Regulation.
Consent for publication
Informed consent for publication was taken from all participants involved in
the study.
Competing interests
The authors report no competing interests.
Author details
Division of Surgery & Cancer, 10th Floor Queen Elizabeth the Queen Mother
Wing (QEQM) St Mary’s Campus, London W2 1NY, UK. 2West Middlesex
University Hospital, Twickenham Road, London TW7 6AF, UK.
11.
12.
13.
14.
15.
16.
17.
18.
1
19.
Received: 1 December 2020 Accepted: 18 March 2021
20.
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