Living lab smartQare, Sensire and NAAST

Due to the aging population in the Netherlands, the group of people of 65+ will
grow very quickly in the coming decade. The share of people with an age over 65
in the Netherlands is expected to increase from 18.5% in 2017 to almost 24% in
2030, an increase of more than 1 million elderly people. In 2030, there will be
26% more people with an age of 75+ than today (Van Duin & Stoeldraijer, 2017)
(CBS, 2014). In contrast, the working population will decrease in absolute
numbers. Currently, 1 out of 7 people in the Dutch workforce works in
healthcare. Given the growing demand for care, without any actions, this will
need to increase to 1 out of 4 people by 2040 (Van Duin & Stoeldraijer, 2017)
(CBS, 2014).

Healthcare needs innovative solutions to be able to continue to guarantee
quality, affordability and accessibility of care, in a situation where the
shortage of personnel is increasing (125,000 vacancies in elderly care are
expected by the end of 2022) and the demand for care will only increase due to
an aging population (Vermeeren, 2019).

Most elderly people wish to stay at home as long as possible, but often
physical disabilities and cognitive impairment make this difficult (Roy et al.,
2018). Dutch government policy focuses on supporting elderly people to continue
to live their life independently at home as long as possible (Ministerie van
Algemene Zaken, 2021). Given the vulnerability of this population, it is
important to monitor their well-being, while living independently, in order to
prevent deterioration of health conditions. In the Netherlands in 2020, per day
14 people died as a consequence of a fall, of which 12 were elderly people
(Letsel Informatie Systeem 2011- 2020, VeiligheidNL; Bevolkingsstatistiek 2011-
2020, Centraal Bureau voor de Statistiek; Doodsoorzakenstatistiek 2019,
Centraal Bureau voor de Statistiek). Often, these deaths were the result of a
deterioration of the health condition, due to the fact that the fall remained
unnoticed and people were laying on the floor for a long period of time.

Continuous monitoring of vital signs using wearable devices has been found to
allow for early detection of clinical health deterioration in intensive care
units (Leenen et al., 2020). There is a growing interest in using remotely
continuous monitoring as a common practice with the objective to allow timely
intervention from health professionals (Askarian et al., 2019 & Pataranutaporn
et al., 2019). These findings may be transferable to the homecare setting, but
have not been sufficiently investigated yet. Moreover, with progress in
medicine and healthcare systems, the average life expectancy of human beings
has increased to more than 80 years of age, which results in more falls among
the elderly population (Ramachandran & Karuppiah, 2020). The health
consequences of a serious fall have a great impact on someone's mood and
independence and can even result in death (Kannus et al., 2015). The effect of
using continuous fall detection for elderly people in a home setting has yet to
be established, but could possibly contribute to a more confident, independent
and longer life.

The viQtor solution can play an important role in remote monitoring of people
living at home. The viQtor solution consists of a medical wearable (viQtor), to
be worn in an armband around the upper arm and a cloud platform (monitoring
system). viQtor continuously (24/7) measures skin temperature, heart rate,
oxygen saturation and activity. The system transfers these measurements every
five minutes to the cloud platform (via the narrow band internet of things).
viQtor also contains fall detection and a personal help button. In case of a
detected fall, the activation of the help button or a deviating measurement of
a vital function, the solution transmits an alert and the location of the
primary participant is also transmitted. Via the cloud platform the monitoring
information is selectively shared with professional and informal caregivers.
The viQtor solution is intended to monitor people with one or more chronic
conditions (in particular COPD and heart failure patients) and/or an increased
risk of falling, in order to early identify (and possibly predict) a
deterioration of the health situation, so that timely action can be taken
and/or the treatment can be adjusted. viQtor is not meant for the monitoring of
acute problems based on vital functions.

As the viQtor solution offers continuous remote monitoring of people*s health
situation, it could possibly contribute to people*s quality of life and quality
of care. Furthermore, based on literature research and analysis, in case of
national implementation of the viQtor solution, the potential financial impact
in the first year is a cost reduction between ¤730 and ¤830 million*. The
rationale for this estimate can be found in attachment *C1c Business case
viQtor solution*.

To further investigate the full potential of the viQtor solution, it is
important to test the usability of the viQtor solution and to examine to what
extent it fulfils its intended purpose in clinical practice.

Primary objective
1) To evaluate the usability of the total viQtor solution applied and used 24/7
in clinical practice.
This includes the ease of use and/or usability of:
the wearable, charger and armband by the primary participants/users
the *care circle app* by the informal caregivers and the primary
participants/users
the *healthcare professional app* by the healthcare professionals
the portal by the healthcare professionals
the portal by employees of the medical service centre

The study is a single arm usability mixed methods study in which 20 target
users will test the viQtor solution for four weeks. From here on, they will be
referred to as the *primary participants*of the study. The target users are
all patients who receive homecare from Sensire The medical service centre,
NAAST, will do the 24/7 monitoring of the primary participants via the
monitoring portal. Healthcare professionals will get access to the health data
of the primary participants via the portal and the app. Informal caregivers
will get access to the app, to be involved in the care process and assist the
primary participants in the use of the viQtor solution. Employees of medical
service centre NAAST, healthcare professionals of Sensire and informal
caregivers of the patients will be the secondary participants of this study.

During the study, primary participants will be asked to wear viQtor 24/7 for 4
weeks. Primary participants are asked to continue with their normal life while
wearing viQtor. Additional actions for primary participants, associated to the
participation in this usability study are: charging viQtor for 2 hours every
day, washing the viQtor armband every now and then and keeping a diary to note
any noteworthy feedback regarding their experiences with viQtor. Primary
participants will be asked to press the personal help button when they need
help immediately, in addition to (and never instead of) their current personal
alarm system, if applicable. The primary participants will be called, once
every two days for 5 minutes, to check if they are experiencing any
inconveniences and if everything is working according to its intended purpose.

The monitoring portal will be used 24/7 by employees of NAAST for the
monitoring of primary participants. In case an alert is received by NAAST, due
to the activation of the personal help button, the detection of a fall or an
abnormality of measured vital functions, NAAST will contact the primary
participant and will execute their existing protocol. In case needed, the care
team of Sensire of the primary participant will be contacted to support the
follow up, according to the existing protocols of NAAST and Sensire. NAAST will
call the primary participants, once every two days for 5 minutes, to check if
the primary participant is experiencing any inconveniences and if the viQtor
solution is working according to its intended purpose.

At the end of the test period, primary participants, informal caregivers,
healthcare professionals of Sensire and employees of the medical service
centre, NAAST, are asked to complete a questionnaire or participate in an
interview, regarding the ease of use and usability of the viQtor solution. The
questionnaire for the primary participants will be administered in person.

The primary participant's existing home care remains unchanged. Where
applicable, based on the measurements and alerts that are generated by the
viQtor solution, additional checks of primary participants will be performed,
according to an established protocol.

Burden:
The subjects are involved in the study in such a way that they will wear and
test viQtor as much as possible for 4 weeks. They will not have to make any
changes to their daily activities while testing viQtor. The care of the subject
remains as contracted and additional checks may be performed on the subjects
based on the measurements of viQtor. Existing care will not be adjusted based
on viQtor's measurements.

The subjects will be interviewed during the course of the study regarding the
wearing comfort and ease of use of viQtor and asked to keep a logbook if they
notice any particulars regarding the use of viQtor. ViQtor will measure skin
temperature, heart rate, oxygen saturation and activity during the wearing
period and provide an alert if a subject should fall or press the personal help
button. The test subject does not have to do or not do anything for these
measurements.

Risks:
1. Subjects with extremely sensitive or fragile skin may experience minor skin
irritation or minor skin damage as a result of wearing viQtor on the upper arm.

Consequence (1-5): 3
Probability (1- 5): 2
General risk (1-25): 6/25

Risk mitigation measures:
The viQtor carrying strap is adjustable and can be tightened to fit any arm.
The following measures are taken to prevent minor skin irritation or minor
damage to the skin:
A. Extremely sensitive skin is an exclusion criterion for participation
B. The researchers instruct the user, caregiver and healthcare professional to
tighten the sling so that two fingers still fit between the sling and the arm.
C. The subjects will be regularly checked by healthcare professionals for
negative effects / damage on the skin beyond the expected normal skin
impression of viQtor and measures will be taken if necessary (possibly
discontinuing participation).
D. Subjects are instructed to remove the strap immediately if they suspect skin
damage.
E. The viQtor strap is designed with a medically approved fabric and with the
aim of being as comfortable as possible for the wearer


2. Risks of bacteria and skin infections from wearing

Consequence (1-5): 3
Probability (1- 5): 2
General risk (1-25): 6/25

Risk mitigation measures:
A. viQtor has a smooth surface and the band is hyperallergenic.
B. The user information includes cleaning instructions for the device and for
the sling.
C. The sling strap is easy to replace and washable.

3. The subjects of the participating care organization in the study (the
intended users of the portable aid) mainly consist of elderly people (not in
life-threatening situations) with care provided at home by the care
organization. Due to the vulnerability of the intended users, it cannot be
ruled out that life-threatening situations may arise during the investigation,
with critical or fatal injuries as a possible outcome. The viQtor solution is
not intended to detect acutely life-threatening situations in a timely manner -
to the extent that such situations are detected, the urgency of such a
measurement / notification has not been taken into account in the design and
the timeliness of the becoming available these measured values **/ messages are
not made a statement and a guarantee is issued.

Consequence (1-5): 5
Probability (1- 5): 1
General risk (1-25): 5/25

Risk mitigation measures:
In the event of a life-threatening situation, the normal functioning of viQtor
may not contribute (either positively or negatively) to addressing the user's
situation. Although viQtor may not be able to make a positive contribution to
the treatment of the life-threatening situation in such a situation, the use of
viQtor will not worsen the situation. viQtor is a device that is not intended
as a medical device in life-threatening situations. This is also included as
such in user information.

From a risk/benefit perspective, smartQare (the device manufacturer) believes
that there will be no negative impact of viQtor on the user, but in most
situations will have a positive impact on the care provided and actions during
and after situations where help and/or medical assistance is required,
especially when compared to a situation where the wearer does not use a
monitoring solution. There is no service associated with this study, but a
healthcare professional from the healthcare center will periodically analyze
the data 24/7 and perform an extra check on test subjects, if the received
measurements give reason to do so.