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Frontiers in Public Health 01 frontiersin.org
e-VITA study protocol: EU-Japan
virtual coach for smart aging
RobertaBevilacqua
1, VeraStara
1, GiulioAmabili
1,
AriannaMargaritini
1, MarcoBenadduci
1, FedericoBarbarossa
1,
ElviraMaranesi
1
*, Anne-SophieRigaud
2,3, SebastianDaChuna
2,3,
CeciliaPalmier
2,3, JohannaMoller
4, RyanBrowne
5,
ToshimiOgawa
5 and RainerWieching
6
1 Scientific Direction, IRCCS INRCA, Ancona, Italy, 2 Université de Paris, Maladie d’Alzheimer, Paris,
France, 3 Services de Gériatrie 1 & 2, AP-HP, Hôpital Broca, Paris, France, 4 Diocesan Caritas Assosiation
of the Archdiocese of Cologne e.V., Cologne, Italy, 5 Smart-Aging Research Center, Tohoku University,
Sendai, Japan, 6 Institute for New Media & Information Systems, University Siegen, Siegen, Germany
Aim: The aim of this study is to report a trial protocol for assessing the
improvement of older adults’ well-being, promoting active and healthy aging,
and reducing the risks of social exclusion, using a virtual coach.
Background: Increased longevity brings with it reduced autonomy and
independence, and it is therefore necessary to act with preventive measures that
can promote active and healthy aging. With the development of technology,
new tools have appeared, including virtual coaches, which can enable people
to lead a healthy lifestyle by identifying individual needs and goals and providing
personalized recommendations and advice. However, it is important that
these coaches take into consideration the inter-individual and cross-cultural
dierences of each person.
Design: A randomized controlled trial is proposed.
Methods: This study will recruit 240 healthy subjects aged 65 years and older.
Participants will be assigned to an experimental group that will receive the
e-VITA system or to the control group that will receive an information booklet
only. The primary outcome measure is the person's quality of life (QoL). Data
will becollected at baseline, 3 months after the trial, and at the end of the trial,
after 6 months.
Discussion: This study will evaluate the eectiveness of the e-VITA system,
consisting of a virtual coach, several sensors for monitoring, a smartphone for
use at home, and a booklet, in improving the older person's quality of life. The
increased perceived well-being will also be linked to improvements in other
areas of the person's life, psychological and cognitive status, the area of sociality,
nutrition, and eHealth literacy.
KEYWORDS
older adults, virtual coach, protocol, intrinsic capacity, well-being, physical activity,
frailty
OPEN ACCESS
EDITED BY
Constantinos S. Pattichis,
University of Cyprus, Cyprus
REVIEWED BY
Elena Carrillo-Alvarez,
Blanquerna Ramon Llull University, Spain
Bayram Akdemir,
Konya Technical University, Türkiye
*CORRESPONDENCE
Elvira Maranesi
e.maranesi@inrca.it
RECEIVED 11 July 2023
ACCEPTED 16 February 2024
PUBLISHED 12 March 2024
CITATION
Bevilacqua R, Stara V, Amabili G, Margaritini A,
Benadduci M, Barbarossa F, Maranesi E,
Rigaud A-S, Da Chuna S, Palmier C, Moller J,
Browne R, Ogawa T and Wieching R (2024)
e-VITA study protocol: EU-Japan virtual
coach for smart aging.
Front. Public Health 12:1256734.
doi: 10.3389/fpubh.2024.1256734
COPYRIGHT
© 2024 Bevilacqua, Stara, Amabili, Margaritini,
Benadduci, Barbarossa, Maranesi, Rigaud, Da
Chuna, Palmier, Moller, Browne, Ogawa and
Wieching. This is an open-access article
distributed under the terms of the Creative
Commons Attribution License (CC BY). The
use, distribution or reproduction in other
forums is permitted, provided the original
author(s) and the copyright owner(s) are
credited and that the original publication in
this journal is cited, in accordance with
accepted academic practice. No use,
distribution or reproduction is permitted
which does not comply with these terms.
TYPE Study Protocol
PUBLISHED 12 March 2024
DOI 10.3389/fpubh.2024.1256734
Bevilacqua et al. 10.3389/fpubh.2024.1256734
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Introduction
Aging brings with it some chronic conditions, along with the
reduction of some functions, (1–3) which can lead to a loss of
autonomy and frailty. e care of older adults with a loss of autonomy
is therefore becoming a major social, medical, and economic issue due
to the insucient number of family or professional carers, enabling
older adults to live at home as long as possible and delay entry to
institutionalization (4). However, aging is not the same for all
individuals. It is dependent on many factors such as genetic factors
that cannot bemodied and environmental factors including lifestyle
(5). It is on the latter that preventive actions can be carried out
throughout life (1). In addition to preventive action, the development
of new care solutions is important (6), to reduce or minimize the
consequences of these age-related diseases, support the health system,
and promote active and healthy aging.
Background
Europeans are living longer and longer. According to INED (7)
the life expectancy of a European woman is 83.7 years and 78.3 years
for a man in 2018. Japan is the country with the highest life expectancy.
Women live on average 88.1 years and men live on average 81.9 years
(7). However, the increase in life expectancy is not necessarily
accompanied by an increase in healthy life expectancy. In Europe, a
woman can expect to live in good health for an average of 64.5 years
and a man can expect to live in good health for an average of
63.4 years (8).
As people age, some of their cognitive functions deteriorate (9),
and they experience psychological and physical (10–12) diculties.
ese changes generate an increase in the workload required by both
family and health professionals (13, 14). For these reasons, it is
necessary to act with a view to prevention, starting with the concept
of active aging. Active and healthy aging refers to the maintenance and
development of functional abilities that enable older adults to live well
(World Health Organization, n.d) in terms of physical, mental, and
social health while actively participating in society.
With the emergence of the concept of healthy and active aging and
the identication of factors that contribute to the development of
age-related diseases and loss of autonomy, health organizations have
tried to improve their strategies to prevent these risk factors and
diseases (15). Dierent structures, organizations, or professionals oer
prevention services such as physical, cognitive, emotional, or social
activities. However, access to private professionals for prevention
targeted to individual needs and preferences is expensive, whereas the
oer of public organizations is only slightly customizable and may not
beaccessible to all seniors. is inequality of access is reinforced by
the current health context linked to the COVID-19 crisis, which has
led to the cessation or postponement of workshops or face-to-face
activities in sports and intergenerational or cultural clubs. A number
of videoconference activities have been developed over the past years.
However, this remote format does not facilitate the personalization of
interventions. With the development of technology, new tools have
appeared, including virtual coaches, which seem to beof interest in
supporting the behavior of individuals. A virtual coach is dened by
Siewiorek et al. (16) as a personalized system that continuously
monitors the activities and environment of its users. Virtual coaches
detect situations where an intervention would be desirable and
proposed to the user. To this end, coaches take the form of activity
sensors combined with a coaching application located on the Internet,
a smartphone, a sensor (17), or a social assistance robot (SAR) (18).
Technology plays an important role in the aging process, impacting
both individuals and society as a whole. On a personal level, wearable
gadgets and health applications keep track of one’s well-being, and
telemedicine oerings enhance the availability of healthcare services.
At the societal level, health eciency, data-driven policies, and the
development of social platforms connecting users have a positive
inuence. However, challenges such as equitable digitization and
accessibility require attention to ensure a benecial and inclusive
impact, especially considering the skill level of the users of older than
65 years with technology, not only from a user skills perspective but
also from a tool acceptance perspective (19, 20). In this regard, several
studies have been conducted that quantitatively and qualitatively
assess access to the Internet of ings (IoT) among the older adult
population (21, 22).
rough a personalized approach, the virtual coaching system can
enable people to live a healthy lifestyle, identifying personal needs and
goals and providing appropriate risk predictions and individualized
recommendations (23, 24). ese devices cover a variety of domains
and audiences (25). ere are a multitude of virtual coaches and apps
for the promotion of nutrition (26), physical activity (27), mood, sleep
(28), and even more clinical applications, such as rehabilitation (29)
or monitoring of cardiovascular pathologies (30).
ere are virtual coaches for adults, children with autistic
disorders, and older adults. ese tools have attracted interest from
healthcare organizations and consumers for promoting health,
wellness, physical activity, and lifestyle improvement (31). e use of
these virtual coaches and apps has great potential to help older adults
improve their quality of life by addressing age-related issues and the
physical and social implications of aging (32). Moreover, embracing
these proactive measures with the assistance of a virtual coach
empowers older adults to maintain independence and comfortable
living in their homes for an extended period (33). is reduces the
need for constant monitoring by health professionals, limits the costs
that would otherwise beincurred (32), and helps mitigate the wider
impact of demographic aging on healthcare (4).
However, the technologies developed for healthy and active aging
have some limitations. Indeed, they are mainly used for short period
of time and are poorly integrated into the daily lives of older adults,
thus limiting their benets (6). Moreover, interactions with these
technologies are not ideal since they do not lead to realistic and
satisfying social interactions due to technologies that are not yet
advanced enough (34). It is therefore necessary to design and evaluate
new products that consider the needs and preferences of seniors and
their relatives for a sustainable and optimal use of these devices (35).
e aim is to enable seniors to live independently in their own homes
for as long as possible, preventing social isolation and encouraging
active participation in social and group activities.
In this context, the creation of an intercultural and customizable
virtual coach may represent an eective solution. rough cooperation
between European (Italy, France, and Germany) and Japanese
partners, the e-VITA project proposes dierent technological tools
that are adapted to older adults and their daily lives, investigating the
eect of cultural aspects in accepting technology and how this aects
the outcome. In tackling the task of craing these technological tools,
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the e-VITA project takes on a comprehensive approach. is involves
seeking input from all stakeholders at both the personal and societal
levels. By engaging older adults, their informal and professional health
caregivers, community members, and policymakers, the project aims
to foster collaboration. e insights gained from these consultations
are then mapped and utilized to comprehend the contextual use and
identify potential users of the system (36, 37). e inclusion of
dierent types of beneciaries in all the countries could support local
governments to adopt and adapt cross-national policies for AHA that
fulll the real needs of older adults, respecting dierent cultural
perspectives. erefore, the functionalities and services available and
proposed are in response to the needs of older adults and concern
social relations, physical activities, skills, autonomy, stimulation,
communication, and safety.
The study
Study setting
e study will beconducted at the Center for Cognitive Disorders
and Dementia (CDCD) of the Neurology Unit of the Istituto Nazionale
Ricovero e Cura per Anziani IRCCS INRCA, Ancona, Italy. In
Germany, the study will becarried out by the Diözesan-Caritasverband
für das Erzbistum Köln e.V. (Diocesan Caritas Association for the
Archdiocese of Cologne e.V.). In France, the study will beconducted
by Hôpital Broca, Paris. In Japan, three institutes will carry out the
study, namely, Tohoku University –Smart Ageing Research Center,
J.F. Oberlin University, and Misawa Homes Institute of Research and
Development Co. Ltd.
Aim
e research is structured as a randomized controlled trial with
the objective of enhancing well-being in older adults, promoting
active and healthy aging, contributing to independent living, and
mitigating the risks of social exclusion through the utilization of a
virtual coach. Participants will be divided into two groups: the
experimental group (EG), receiving a virtual coach, a smartphone, and
a booklet, and the control group (CG), receiving only a booklet.
Assessments will be conducted at the baseline (T0), midway
through the intervention (aer 3 months—T1), and at the conclusion
of the intervention (aer 6 months—T2). e primary aim of the
study is to gauge the enhancement of participants’ quality of life (QoL)
using EQ5D 5 L. Additionally, the research will assess the usability,
user experience, acceptability, and fulllment of needs aer using the
e-VITA system. It will also explore potential changes in various
health-related aspects, such as nutrition, loneliness, and health literacy.
Objectives
e general objective is to improve the well-being of older adults,
promote active and healthy aging, contribute to independent living,
and reduce risks of social exclusion of 240 healthy older adults
recruited from Europe (France, Germany, and Italy) and Japan by
making use of a digital tool for personalized virtual coaching support.
Design/methodology
Recruitment
Patients are selected by the Neurology Operating Unit and
Rehabilitation Medicine Operating Unit of IRCCS INRCA in the
Ancona branch. Aer a reection period of 2 weeks followed by
reading the information letter and the consent form received by email,
the participants who conrmed their wish to participate in the
research by writing or orally will beinvited by the investigator to
consult a doctor during 3 months, preceding the start of the research.
e doctor, volunteering to carry out the inclusion visits, will bethe
rst to give the participants an information letter and two consent
forms. Once the consent forms have undergone thorough
proofreading and received signatures from both the participant and
the doctor, the doctor will assess the participant’s eligibility for the
research using an anamnesis Clinical Frailty Scale (CFS) (38),
Montreal Cognitive Assessment (MOCA) (39), Geriatric Depression
Scale (GDS) (40), and Short Physical Performance Battery (SPPB)
(41). is comprehensive medical examination, conducted before the
commencement of the experiment, will determine whether
participants meet the inclusion criteria. ose who have signed the
consent form but do not meet the inclusion criteria as conrmed by
the doctor will beexcluded from the research. e trial is scheduled
to commence in May 2023 and is anticipated to conclude in
December 2023.
Participants
Each European country will enroll 40 subjects.
e inclusion criteria are:
• Age ≥ 65 years;
• Ability to provide informed consent;
• Able to stand and walk unaided;
• No acute or untreated medical problems;
• MoCA ≥22;
• GDS < 9;
• SPPB ≥7;
• Clinical Frailty Scale score between 2 and 4;
For patients with MoCA scores between 22 and 25, an informal
caregiver is required to bepresent during the explanation of the
project and the administration of the assessment scales.
e exclusion criteria are:
• Failure to meet the inclusion criteria;
• Use of active implant or non-implant medical devices;
• Allergy to nickel;
• Simultaneous participation in other studies;
• Absence of written informed consent;
• Occurrence of a myocardial infarction or stroke within the past
6 months;
• Presence of painful arthritis, spinal stenosis, amputation, painful
foot lesions, or neuropathy that signicantly limits balance
and mobility;
• Uncontrolled hypertension;
• Presence of a pacemaker or implantable cardioverter-
debrillator;
• Advanced Parkinson’s disease or other neuromuscular disorders;
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• Diagnosis of metastatic cancer or undergoing immunosuppressive
therapy;
• Signicant visual or hearing impairment.
Sample size determination
In the study by Summers etal. (42), the EuroQol 5 dimensions
(EQ5D) was evaluated in two groups of older adults with physical
pre-frailty conditions. EQ5D, a test widely used to measure health
status-related quality of life, was used to calculate the sample size.
Assuming an overall sample size of 220 subjects (110 cases and 110
controls), 2 repeated assessments (baseline and follow-up), a
signicance level of 0.05, power of 90%, a correlation among
repeated measures of 0.5, and a non-sphericity correction ε of 1in
an ANOVA model within-between interactions, the achieved eect
size for this study is 11% (corresponding to a small eect size in a
coherent way with the literature). Even factoring in a dropout rate
of 10%, the total number needed would be240 subjects, evenly
divided into 120 cases and 120 controls. e hypothesis is that this
sample size is more than adequate to detect variations in secondary
outcomes. For these secondary outcomes, a treatment eect size is
assumed to besimilar to or even greater than the one identied for
the primary outcome.
Intervention
e interventions are oriented toward the model of intrinsic
capacity (43), and an improvement of the general well-being is to
beachieved through the promotion of the dierent areas. For this
study, 240 healthy older adults will beenrolled. Figure1 illustrates the
owchart, detailing the process of patient selection.
In total, 120 subjects will beenrolled in the experimental
group and will receive the e-VITA platform composed of a virtual
coach, several sensors for monitoring, and a smartphone to use
at home.
e control group will receive only the booklet with nutritional,
cognitive, and physical suggestions.
FIGURE1
Flowchart of the patient selection.
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Equipment
An innovative Information and Communication Technology
(ICT)-based virtual coaching system has been created to identify
subtle changes in the physical, cognitive, psychological, and social
domains of older adults. e e-VITA virtual coach is designed to oer
personalized recommendations and interventions, fostering
sustainable well-being within a smart living environment at home. All
the devices will besupplied by the researchers.
e dierent components of the system are:
• Coaches, consisting of social robots, that will interact with the
users and are guided by apps;
• Sensors (both wearable and domestic) to detect physiological
parameters, physical activities, and behavior of the users; these
sensors are the Huawei smart band (wearable), the NeU device
(wearable), and the DeltaDore system (domestic).
• Smartphones (the chatbot to provide insights, suggestion, and
stimulation about healthy nutrition and physical exercise; the
social platform to encourage users to share their interests).
ese components (coaches, sensors, chatbot, and social platform)
together with the main soware named Digital Enabler (DE)
constitute the Virtual Coach. e DE takes into account dierent types
of data (both from the literature and dierent devices described above
together with the user’s personal data), to make choices in order to
customize the user experience. Choices are made both on the basis of
the data received and the use case considered. e DE operates
directly on the sensors, robots, and chatbots.
Categorizing sensing technologies and coaching devices based on
their inputs is integral to establishing a cohesive and integrated sensor
network. is network possesses the ability to recognize user behaviors,
physiological states, and emotions, ultimately pinpointing a coaching
device that resonates with the user’s preferences and acceptance.
ree categories of sensors could bedistinguished: (1) those
which are worn by the user and aim to sense physiological and
actimetric parameters (user-related devices); (2) those which measure
physical quantities useful for assessing the level of comfort and quality
of the indoor environment and localization of the user (environmental
devices); (3) those installed in the home to monitor user behavior and
activities (home-based devices). For the e-VITA system, all these types
of sensors are combined to make inferences about simple situations of
the users (posture, activity level) in their environment and for
localization in the home and the users’ physiological states. Contextual
information is exploited by the interactive voice-based coaching
system, the virtual coach. Each domain requires the integration of
specic sensors to acquire heterogeneous data, and a coaching device
is selected based on the user’s information, preferences, and technical
characteristics and functionalities performed. is task is performed
by the Use Cases Congurator, a tool that aims at identifying the
optimal conguration of the sensor network and coaching devices to
beused based on the user’s needs and requirements. e coaching
devices can take four forms, namely, Gatebox, Nao, Google Nest Hub,
and Celeste (or DarumaTO for Japan). e specic mobile applications
for the usage scenarios are available on the Android smartphone,
which is provided to the user as a support device.
Technological description of coaches
e coaching devices used in the study are Nao Robot, Gatebox,
and Celeste, substituted by DarumaTO for the Japanese centers
(Table1).
• Nao is a humanoid Robot exhibiting a friendly appearance with
eyes and movements reminiscent of a human being. Nao is
equipped with an array of sensors, cameras, and microphones,
enabling it to perceive and interact with its surrounding
environment and human beings. It is powered by advanced
articial intelligence soware, enabling capabilities, such as
facial recognition, natural language understanding, and learning
from user interactions (44–50).
• Gatebox is an intelligent home assistance device developed that
appears as a holographic projector embedded in a cylindrical
container, housing a virtual editable characteristic. is
characteristic is a virtual assistant equipped with articial
intelligence, designed to interact with users akin to a personal
assistant. From a technical standpoint, Gatebox utilizes
holographic projection technologies to display coach
characteristics within a three-dimensional environment. It is
equipped with microphones and speakers to recognize and
reproduce sound, allowing users to communicate with the
virtual assistant through voice recognition and audio responses.
Gatebox can perform a variety of tasks, such as providing
information related to physical activity recommendations and
giving dietary advice. Moreover, it is designed to provide a more
intimate and personal interactive experience compared with
other virtual assistants, incorporating elements of relationship
and aection in its behavior (51–55).
• CelesTE (56–58) and DarumaTO (59–61) are social robots that
have religion as a principal theme. CelesTE resembles an angelic
statue atop a column inspired by sacred Christianity art and
neoclassical architecture. is social robot incorporates the
golden ratio to transcend its robotic nature and evoke a sense of
holiness. Primarily designed as a “guardian angel” for older
adults, CelesTE serves as a prayer companion and repository of
religious teaching, including the Bible. AI enables short
conversations on sensitive topics and can print selected content.
DarumaTO is inspired by the traditional Buddhist and Shinto
doll called Daruma. It can communicate through visual tracking
and voice and facial expression. Its functionalities are similar to
those of CelesTE, but in the case of design, it results in a device
that has a familiar appearance to a Buddhist or Shinto
older adults.
Such devices are in charge of interacting with the user, exploiting
the dialog features provided by the platform.
e randomization technique, performed by the statistician,
relies on a singular sequence of random assignments. A computer-
generated list of random numbers is employed, and each subject is
assigned a number based on their inclusion order in the study.
Following this method, subjects are randomly allocated to the
utilization of various coaching devices, maintaining an allocation
ratio of ve subjects for each branch.
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Technological description of sensors
e sensors are wearable and environmental, and they are needed
to monitor physiological and environmental parameters. Table 2
presents the sensors available for the study.
On the environmental sensors, Delta Dore motion detectors can
detect the presence of a moving person in a room, which provides
information on the occupancy of rooms and the movement of
occupants from one room to another. is information can beof
interest as a complement to the wearable sensors, especially when they
are forgotten or under load. In this case, it is possible to use
environmental sensors, especially motion sensors, to infer user
activity. e sensor network, especially the infrared-based presence
detection sensors (PIR sensors), should bestrategically installed to
eectively monitor the user, particularly in the designated areas of
interest within the smart home environment. A predetermined
selection ensures coverage of specic rooms. e primary objective of
this system is to initially recognize the resident’s movements and
potentially infer activities within a particular room of the apartment.
e Use Case Congurator aggregates all the information detected by
the environmental sensors, serving as input to feed the algorithms.
ose sensors are:
• The Wireless motion detector-Delta Dore DMB TYXAL. It is
a motion sensor and not a presence detector. It has a range of
12 m with a 90⁰ opening angle. It generally covers one room,
and detection is limited to opaque walls. Its autonomy is of
the order of 10 years. The detector is based on passive
infrared technology. The motion detection function consists
of a pyroelectric sensor, the associated electronics, which
process the signal and control the sensor power supply in an
optimized way, and finally a lens.
• The Opening magnetic sensor–Delta Dore DO TYXAL+.
DO TYXAL+ is an opening sensor developed to detect
intrusion in dwelling when doors or windows are opened.
It consists of two parts, one of which is attached to the door
or window jamb, and this is the active element. The other
part is a mechanical part that contains a magnet and is
attached to the moving part of the door or window. These
parts are attached to the doors with a double-sided tape.
The sensor consists of a reed switch on the active element
which is closed when the magnetic part is closed and opens
when the magnet moves away from it, i.e., when the door is
open. The technology is simple, robust, and energy-
efficient.
• e Tydom Home. Sensors are battery-powered and
communicate detection and maintenance information to a
central unit. e Tydom Home IP gateway will beused to collect
data from the various products and transfer them to the
e-VITA congurator.
TABLE1 Coaches.
Name Type Description Main functionalities
NAO rob ot Coaching device/Robot
Sobank NAO 5 and NAO 6
humanoid interactive mobile
robot.
Robot platform that allows
multimodal natural language
interaction and robot autonomous
movement.
Google Nest Hub (2e Generation) Coaching device/Virtual assistant Connected speaker enriched
with a 7-chip touch screen
Screen whose brightness adapts to
the room’s atmosphere. It has a
loudspeaker and 3 microphones,
making interaction possible.
Gatebox Coaching device/Hologram
Hologram like device that
projects characters with
which the user can interact.
Internal sensors such as a camera and
a microphone allow the user to
converse with the projected character.
It connects to the Internet via a
wireless LAN. With infrared rays and
Bluetooth, it can also beconnected to
household appliances and other
devices.
CelesTE Coaching device/Robot Prayer companion designed
for Christian Catholic users.
e intended main function of
CelesTE is to bea “guardian angel,”
especially thought for older people. It
can bea prayer companion, and
contains a vast number of teachings,
including the whole Bible. Its AI is
capable of keeping a short
conversation, in which the user may
ask and receive an answer about a
sensitive topic (such as happiness,
death, faith, etc.). It can also printout
a selection of contents.
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Description of the end-users’ platform
e end-user’s platform is composed of a privacy dashboard,
smartphone app, Chatbot, social platform, and use case congurator.
rough those applications, the end-users will becapable of managing
his/her data and receiving information on health activities and social
events. However, the virtual coaches represent the main interface of
the system through vocal communication with the end-users.
• Privacy Dashboard: CaPe oers a privacy dashboard through the
Cape Suite, compatible with any mobile device. is system is
designed to adhere to legal requirements outlined in the GDPR. It
incorporates consent-based data management, technical
mechanisms for verifying compliance with data handling
prescriptions, the right to obtain a copy of personal data, the right
to be forgotten, and transparency tools on data usage. e
consent record maintained by CaPe details who consented, when
the consent was given, what was consented, how the consent was
granted, and any instances of withdrawn consent. CaPe supports
two types of consenting: (1) consenting to process within a
service for a specic purpose and (2) consenting to share data
from a service (source) to beprocessed in another service (sink)
for a specic purpose. e Cape Suite features two frontend
dashboards, catering to end-users (data subjects) and service
providers (data controllers), respectively. e User Self-Service
Dashboard serves as a centralized point for end-users to
overview, verify, and modify data usage settings, understand the
purpose of data processing, view event logs, and adjust linked
services and consents previously granted. On the other hand, the
Data Controller Dashboard is the entry point for service
providers, allowing them to manage semantic descriptions and
registrations of their provided services and view and manage
service linking and consent status given by all users of their
registered services. Some screenshots of the dashboard are shown
in Figure2.
• Smartphone App and Chatbot: e e-VITA project provides a
smartphone app for end-users that functions as the control
center. From there, users can access all relevant apps and
interventions. Furthermore, apps that oer control over system
settings, such as the privacy dashboard, can bereached via the
control center. Specic e-VITA apps (e.g., social platform), but
also external apps, are represented on the dashboard. e app
requires a user prole to beaccessed. Aer opening the app,
users will observe an introduction to app which can beskipped
to the landing page (see Figure3A). From there, e-VITA users
can create a prole using their email address and a secure
password (see Figure 3B). Additional information is not
needed for the sign-up process. e email and password will
be used to log in and access the individual account (see
Figure3C).
Further system control tasks, such as changing the language,
password, or location, can also behandled via the smartphone app.
e language settings can either beaccessed via the landing page (see
Figure4A) or the general app settings (see Figure4B). e general app
settings are always accessible via a menu icon on the top le (see
Figure4C).
e core function of the app is a control center through which
various training interventions (e.g., cognitive training) and chatbots
can bestarted. For this, the dashboard functions as a single point of
contact (see Figure5A). From there, other components of the e-VITA
architecture can beaccessed (see Figure 5B). e dashboard will
provide links to, for instance, data analytics, prole data, performance
indicators, status of the dierent interactive devices, privacy,
and security.
Users may want to use chatbots, social platforms, privacy
dashboards, or other applications outside their home. To enable this,
components of e-VITA that can bereached via URL can beaccessed
from outside the home, given that an internet connection is available.
e dashboard consists of a grid layout with labeled tiles that link to
other components of the e-VITA architecture. It is available in all
languages of the e-VITA project. Users will observe this page aer
logging into their account. It oers a quick overview of all contents
that can beaccessed from the app.
TABLE2 Sensors.
Name / Type Description Main functionalities
DELTA DORE Tydom platform IoT Device/Sensor Set of sensors and measuring devices
and IOT platform. e sensors can
beused with a gateway connected to
any dedicated platform.
Set of smart living sensors
(motion sensors, door sensors,
metering devices) and IOT
platform.
Samsung Galaxy S20+ Smartphone IoT Device Android smartphone To access all the apps and
services
Smart band Huawei
IoT Device/Sensor Wearable smart band that tracks
physiological parameters.
Parameters monitored: activity
level, step, calories, sleep
duration, sleep quality, etc.
NEU XB-01
IoT Device/Sensor
Ultra-compact device with a buttery-
style design that bends in the middle to
conform easily to any individual’s
forehead. Data is transferred via
Bluetooth in real-time to any
smartphone, making it possible to
measure brain activity.
Brain activity is measured using
NIRS technology and the brain’s
rate of blood ow change is
measured using weak near-
infrared light.
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Chatbots are soware agents that use a dialog function, such as a
text or speech interface, and are based on natural language processing
(NLP). e chatbot can beused to extract information from a user’s
statement or input. e chatbot is also connected to the e-VITA
dashboard. e chatbot in itself is a Telegram account that can
automatically answer the text messages sent to it. To start a conversation
with these chatbots, the user can either type ‘/start’ or press the start
button on the screen. Once a piece of text is sent by the user to the
chatbot, the message, the system starts to search for the intent and
extracts entities from the user’s sentence. At the same time, the previous
messages are also taken into consideration for extracting information
that the user might have asked for before. Information is then returned
to the middleware, where the request is further processed.
• Social Platform: e social platform allows the users to register
and enroll in groups. Groups are meant to beinterest areas. Users
may either contact or create groups, based on their personal
interests (e.g., nord walking and cooking classes), and may also
get located to set up feeds, based on the country. Furthermore,
users may benotied of upcoming meetings from groups and
agenda updates of meetings. e main purpose is to establish a
bridge between youth and older adults and between individuals
and communities by creating a social platform in which dierent
types of activities (e.g., cultural, sport, cooking, repairing, sewing,
and gardening) are carried out to stimulate the users in remaining
active. To make it ecient and easy to get connected, living labs,
coaches, and those who oer their services will operate based on
their location, which will be available only for the local
community. Social platform application is maintained based on
the countries and dierent communities (more specically the
local location and helping community directly around the
primary end-users), to oer user services in the interest of the
area. Living laboratories and international study site locations
will beavailable to oer suitable activities to the users based on
their location. For this purpose, in HumHub, Google location
services will beused. Social platform operates as a website that
can beaccessed easily on any smartphone, tablet, and computer.
• Sign up: e application will ask to get permission of location to
detect the user’s country to set up feeds based on the country. e
user will enter credentials on the homepage, once registered.
• Registration: Upon registration, the user has designated roles
such as administrator, service provider, or community
organization (secondary stakeholders). Administrators are users
who have technical responsibilities for the maintenance of the
website, while service providers are users who oer either
voluntary help or coaching. Community organizers are users
who arrange local activities, such as meetups.
• Groups: ere are dierent interest areas based on groups. Users
may contact these groups or create groups based on their interests
by themselves.
• Notication: In this section, the system will notify upcoming
meetings from groups and agenda updates of meetings (update
about the new updates of the app also). Notications can
beturned o in Settings.
• Messages: Users may contact people who initiate the activities or
get contacted by the manager of those activities by getting
detailed information through the chat system. When the users
receive a message, they will benotied by message, such as email,
and it will bemarked on the top of the page. When a user clicks
on the “Message” button, he/she will get a short description of the
message, and in order to reply, users have to go to the
“Conversation.”
• Feed: On feeds, users observe a variety of group meetings in the
upcoming week. Moreover, they can review that volunteer
announcements oer dierent services. e feed page is also
considered as the main page, and users observe a review of the
last activities.
• Settings: Users will beable to change location, language, and
password and beable to log out. Furthermore, it is possible for
the user to change or delete proles on this page. Users can oer
dierent types of services and, at the same time, benet from
oered services. Types of services will beoered under dierent
categories. Users can also change their personal information on
this page. is information includes prole photo, Email, and
location. To make dierent changes to the prole directly, users
have to click on their username, which is on the top of the page.
e pop-up list will beshown, in which users choose “Settings”
to make desired changes. On these settings, user can choose their
desired language to use the application. To change the language,
users have to choose “Settings,” and a core settings list will
beshown, in which the “Language option” will belisted. Figure6
shows some screenshots of the Social Platform.
Use case configurator (UCC)
e Use Cases Congurator (UCC) stands as an independent
soware component within the e-VITA platform, which is tasked with
translating user needs, environmental requirements, and conguration
settings into technical specications for the sensing and coaching
system. is congurator prioritizes the creation of a smart living
environment that balances cost-eectiveness and sensor eciency,
ensuring accurate measurements while identifying optimal devices for
virtual coaching. e overarching goal is to deliver a service tailored
to users’ needs and preferences. e UCC features a graphical
interface, oering insights of end-users into the composition of the
e-VITA platform based on their selected information, preferences, and
goals. Inputs for the congurator include the needs and requirements
of older adults, encompassing details about the living environment
(house architecture, rooms, etc.), living situation (single or multiple
residents), sensor acceptance (wearable or stationary sensors), privacy
settings, and personal information (gender, age, and religion).
Emotion detection system (EDS) module
e e-VITA Emotion Detection System (EDS) module will serve
as one of the basic foundations for an empathic coaching system. at
is, by accurately detecting the end-users’ emotional state, the EDS
enables subsequent, high-level components to exibly adjust their
functioning and end-user interaction, in order to achieve a higher
level of acceptance, usability, and well-being. e EDS layer imports
audio samples from the current speech of the user (pseudonymized)
during the interaction with the coaching devices via speech. en, it
pre-processes these data and decomposes the audio signal into its
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statistical sub-components (anonymized, no reverse-engineering
possible). Based on this, a classication layer detects the currently
most prominent emotion from a xed set of basic emotions. Another
approach will beto add a sentiment analysis to the EDS. is means,
that in addition to the acoustic features of the audio data coming from
the participant, information is extracted that is related to the
participant’s sentiment or opinion, based on Natural Language
Processing (NLP). For this, the audio data will betranscribed to a text,
which will bethen analyzed based on keywords, that represent a basic
emotion. is information will bethen added to the results of the
acoustic analysis, leading to a nal model with labels of basic emotions
such as anger, disgust, fear, joy, neutral, and sadness. As a result,
components, directly modeling the interaction with the end-user, for
instance, dialog management, can then beaugmented to t the user’s
emotional state.
Outcome measures
All outcomes will bemeasured following a standardized operating
procedure. e primary endpoint of the study is constituted by the
improvement in the quality of life aer the use of the e-VITA system,
to bemeasured through the EQ-5D-5L, aer 6 months of training.
e secondary endpoints encompass: (1) adherence to the
coaching intervention, measured by the frequency of technological
device usage, and collected through semi-structured interviews and
technical data; (2) usability and the user experience of the overall
system assessed using the System Usability Scale (SUS) (62) at both
the midpoint and the conclusion of the experiments, along with the
User Experience Questionnaire [UEQ (63) and UEQ+ (64)] in the
middle and at the end of the experiments; (3) improvement in
eHealth literacy, to beaddressed through the eHealth Literacy Scale
(eHEALS) (65), social connectedness through the UCLA Loneliness
scale (UCLA) (66), nutritional state through the short version of
Food Frequency Questionnaire (FFQ) (67) to estimate the frequency
of daily food intake over a period, cognitive status, through Montreal
Cognitive Assessment (MoCA) (39), psychological mood through
the Geriatric Depression Scale (GDS) (40), functional status through
Short Physical Performce Battery (SPPB) (41), participation to
leisure activities through an ad-hoc checklist; meets the participant’s
objectives through ADTPA-5 (scale B and E adapted) (68). A semi-
structured interview will beused to complement the information
collected by questionnaires, focusing on acceptability, attitude,
usability, and cost–benet analysis; other questionnaires will beused
to better understand our participants’ sociodemographics
questionnaire, Clinical Frailty Scale (CFS) (38), Big Five Inventory
– 10 (BFI-10) (69), and Anity for Technology Interaction
(ATI) (70).
Table3 presents a concise overview of all collected data and their
respective collection time points.
e scales which will be used during the evaluations are
described below.
Clinical frailty scale (CFS)
is descriptive scale divides the older participants into nine
classes based on the information provided by them and their relatives:
FIGURE2
Screenshots of the privacy dashboard, where user can manage permissions and find information about data sharing.
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between 1 and 3, the patient is non-frail, pre-frail if 4, and heis frail
from 5 to 9.
Montreal cognitive assessment (MoCA)
Montreal Cognitive Assessment (MoCA) serves as a validated
cognitive test, which is recognized for its high sensitivity in the early
detection of mild cognitive impairment (MCI). MoCA eciently assesses
various cognitive domains, including short-term memory, visuospatial
abilities, executive functions, attention, concentration, working memory,
language, and orientation to time and place. e nal version of MoCA,
accessible at www.mocatest.org, is a 1-page, 30-point test that can
beadministered in just 10 min. Specic details regarding the MoCA items
are as follows: (1) Short-Term Memory Recall Task (5 points): involves
two learning trials of ve nouns and delayed recall aer approximately
5 min; (2) Visuospatial Abilities (4 points): clock-drawing task (3 points),
three-dimensional cube copy (1 point); (3) Executive Functions (4
points): alternation task adapted from the Trail Making B task (1 point),
phonemic uency task (1 point), two-item verbal abstraction task (2
points); (4) Attention, Concentration, and Working Memory (6 points):
sustained attention task (target detection using tapping; 1 point), serial
subtraction task (3 points), digits forward and backward (1 point each);
(5) Language (8 points): three-item confrontation naming task with
FIGURE3
e-VITA dashboard access page that is shown when opening the app (A) landing page, (B) login page, and (C) sign up page.
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low-familiarity animals (lion, camel, and rhinoceros; 3 points), repetition
of two syntactically complex sentences (2 points), phonemic uency task;
(6) Orientation to Time and Place (6 points): assessment of orientation
across various dimensions. e comprehensive nature of MoCA allows
for a thorough examination of cognitive abilities in a relatively short
time frame.
Geriatric depression scale (GDS) 5-item version
is questionnaire assesses the current condition of the patient’s
mood. For the screening required by our study, only the rst ve items
of the scale can be used. e answers highlighted indicate the
statements expected by a non-depressed subject.
Short physical performance battery (SPPB)
It assesses physical performance on the basis of three criteria by
testing balance, walking speed, and chair-raising abilities. is scale is
used for the inclusion of participants (40).
EQ-5D-5L
The scale consists of five dimensions: mobility, independence,
usual activities, pain/discomfort, and anxiety/depression. Each
dimension has five levels: no problems, mild problems, moderate
problems, severe problems, and extreme problems. The
participant is asked to indicate his/her health status by ticking the
box corresponding to the most appropriate statement in each of
the five dimensions. The numbers from the five dimensions can
becombined into a 5-digit number that describes the health status
of the participant.
Assistive technology device predisposition
assessment (ATDPA-5 – scales B and E)
is scale assesses the person’s need for technology. It has two
parts. A part on the individual with 9 items assessing functional
capacities and 11 items on well-being. ese rst 20 items are to
belled in on a ve-point Likert scale, ranging from 1: poor/not
satised to 5: excellent/very satised. Finally, this last part also assesses
personal and psychosocial characteristics. ere is no threshold value
for these last items. e second part deals with technological tools
with 12 items, highlighting their expectations in terms of benets
toward three technological tools. ere is no threshold for this scale,
but the scores range from 0 to 60 (sum of the statements). e tool
with the highest score is considered the most important. is scale is
used at the beginning of the experiment. Only parts B and E will
beused and adapted for the project (68).
Big five inventory – 10 (BFI-10)
e BFI-10 (69) is a concise 10-item scale designed to assess the
Big Five personality traits: extraversion, agreeableness,
conscientiousness, emotional stability, and openness. Participants rate
each item on a scale ranging from 1 (disagree strongly) to 5
(agree strongly).
Short food frequency questionnaire (FFQ)
FFQ serves as a scale to estimate the frequency of daily food
intake over a specied period. is questionnaire seeks information
on how oen certain foods are consumed (e.g., once daily, once or
twice a week, and once or twice a month) and the approximate serving
size. It is designed to capture data on habitual food intake rather than
quantifying the exact nutrient amount ingested. In Europe, partners
will utilize the scale developed by Robinson etal. (67).
eHealth scale
e eHEALS is an 8-item assessment designed to gauge eHealth
literacy, measuring consumers’ collective knowledge, comfort, and
perceived skills in nding, evaluating, and applying electronic health
information to address health-related issues.
FIGURE4
e-VITA dashboard settings control—(A) language settings, (B) settings page, and (C) dashboard lateral menu to access settings.
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Revised UCLA loneliness scale version 3
e revised UCLA Loneliness Scale Version 3 is a dependable and
consistent questionnaire-based measure designed to assess trait loneliness
(66). Comprising 20 items, respondents rate each item on a scale from 1
(never) to 4 (oen), yielding a loneliness score ranging from 20 to 80. A
higher score on the scale indicates a greater level of trait loneliness.
System usability scale (SUS)
The System Usability Scale (SUS) stands as a reliable tool for
assessing usability, featuring a 10-item questionnaire with five
response options ranging from ‘strongly agree’ to ‘strongly
disagree’. This versatile scale enables the evaluation of a diverse
range of products and services, spanning hardware, software,
FIGURE5
e-VITA dashboard homepage where all the apps and services are shown and accessible.
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mobile devices, websites, and applications. Its ease of
administration to participants, suitability for small sample sizes,
and ability to effectively distinguish between usable and unusable
systems contribute to its widespread applicability and reliability
in usability assessments.
User experience questionnaire (UEQ)
e questionnaire incorporates scales that provide a
comprehensive assessment of the user experience. It encompasses
classical usability dimensions such as eciency, perspicuity, and
dependability while also evaluating user experience aspects, such as
TABLE3 Schedule of assessment and outcome measures.
Dimension Scale R T0 T1 T2
Clinical frailty scale CFS X
Cognitive status MoCA X X
Psychological status GDS X X
Physical capacity SPPB X X
Overall health status Clinical anamnesis X
General information Socio-demographics questionnaire X
Quality of life EQ-5D-5L X X
Goals and expectation ATDPA-5 (Scale B and E) X X (Scale B)
eHealth literacy eHEALS X X
Social connectedness UCLA X X X
Personality Big Five Inventory – 10 items X
Nutrition Short FFQ X X
Adherence Collected through the system and
interview X X
Leisure activities Physical and leisure activity checklist X X X
Usability SUS X X
User experience UEQ, UEQ+ X X
Attitude, usability, acceptability and cost–
benet analysis Semi-structured interview X
Anity for technology interaction ATI X
R, recruitment; T0, rst evaluation; T1, intermediate evaluation; T2, nal evaluation; CFS, Clinical Frailty Scale; MoCA, Montreal Cognitive Assessment; GDS, Geriatric Depression Scale;
SPPB, Short Physical Performance Battery; ATDPA, Assistive Technology Device Predisposition Assessment; FFQ, Fo od frequency questionnaires; SUS, System Usability Scale; UEQ, User
Experience Questionnaire; ATI, Anity for Technology Interaction.
FIGURE6
Screenshots of social platform—(A) thematic groups of interests to which the user can subscribe and (B) view of the members of one group.
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originality and stimulation. is holistic approach ensures a well-
rounded understanding of the overall user experience, considering
both functional and experiential aspects of interaction with the system
or product.
User experience questionnaire + (UEQ+)
To measure the user experience of the voice interaction in
particular, additional scales such as response behavior or response
quality from the UEQ+ can beadded.
Anity for technology interaction (ATI)
e scale, evaluated in 2019 from the study by Franke et al.,
measures a person’s interaction-related anity with technology. It
consists of nine items and uses a six-point Likert scale ranging from
1 = completely disagree to 6 = completely agree (71).
Physical and leisure activity checklist
An ad-hoc checklist has been developed to collect information on
engagement in leisure and physical activities of the participants
during the e-VITA trial. It contains questions, which are rated on a
six-point Likert scale, about common physical and leisure activities
and a section to report the personal practices and frequency put in
place by the participants.
Scales at T0 and T2 for the control group
These two scales are necessary to better understand our
participants. The scale at T0 focuses on the dimensions of daily
life, social, and prevention. The T2 scale focuses on the
participants’ feelings, following the experiment, their experience
with the information booklet and its usability, and their
well-being.
Risk–benefit analysis
During the use of robotic platforms or, in wider terms of
technological applications, a general diculty in distinguishing
between the articial world and reality may occur. Especially, in the
case of vulnerable older adults, the interaction may generate a
general feeling of attachment and dependency. To avoid this,
e-VITA has been designed to not look like a human but to preserve
articial aesthetics, as suggested by the guidelines. In addition,
during the rst contact with the participants but also during all the
interventions, researchers will be in contact with the users,
continuously stimulating awareness about the technological
applications and monitoring the appropriateness of the use of the
solution in terms of autonomy of the users, specic needs, and
personal preferences. In particular, following the recommendations
provided by Comitato nazionale di bioetica (Cnb) of the Ministry
of Health (71) on robotics and roboethics, the exit strategy of
e-VITA will aim to:
• promote adequate experimentation of robotics in the eld
assistance in order to ensure conditions for the physical and
psychological integrity of the user, explaining the risks and
benets, which was highlighted also in the informed consent;
• ensure both equitable access to robotic and general technologies
and the use of robots to assist and not to replace humans, in order
to avoid delegating the irreplaceable human task of care and
assistance to the machine;
• the need that the introduction of robotics in medicine entails
always the real consideration of the benets, of the complexity of
the change complete with the structure of the services and the
economic burden that this entails.
ere is a risk that the older adults may wish to stop interacting
with the technological devices (for example, because they do not like
the NAO robot). In this case, the experiment will beimmediately
stopped and terminated.
e presence and use of technological devices (virtual coaches
and sensors) in participants’ homes can bea source of discomfort.
erefore, pre-studies with end-users (older adults) and stakeholders
(informal carers, health professionals, family, NGOs etc.) have been
carried out in order to propose virtual coaches that meet the needs of
older adults. In addition, safety procedures were also designed to limit
the risks as much as possible.
To protect the safety of participants:
• participants will beinformed about the appropriate use of the
virtual coach or technological device (e.g., cannot lean on the
technological device or make a movement that could
destabilize it);
• the researcher will train the participant in the use of the sensors
and beavailable in case of problems;
• the technological devices will beplaced in the participant’s home
in a conguration that allows them to beused safely.
In the case of adverse events occurring despite the precautions
described above:
• participants will beinstructed to press the “o ” button on the
device or to disconnect it, according to the instructions in the
user manual;
• participants will call the researcher, who will assist the participant
in case of problems;
• participants will beable to call the researcher, who will come and
ensure that no damage has been caused to the participants or to
any other person.
To mitigate potential technological dependency, especially with
humanoid or theomorphic robotic systems, participants will undergo
instruction and training for the appropriate and limited use of virtual
coaches. Researchers will maintain contact with participants to ensure
proper guidance. Despite the existing risk, it is crucial to acknowledge
that current technology has not reached the level of sophistication,
which is necessary for natural human–robot interaction. Presently,
there is limited progress in developing coaching devices that are
capable of minimal social interaction, involving emotional and
psychological engagement in controlled conditions. However,
precautions, including the provision of adequate training and daily
support/monitoring by researchers, are essential to safely use coaching
devices in emotional, social, and psychological terms and prevent
potential future dependency.
Finally, if aer the experimentation, the participants would ask for
a longer use of the system, they will beasked to beinvolved in similar
studies, to ensure the continued use of the technology. Moreover, aer
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the end of the study, the opportunity to receive personalized support
on everyday technology will be oered to the participants about
eHealth literacy and similar solutions for health.
Data management
e project is dedicated to upholding the anonymity and
condentiality of participants throughout all stages, encompassing
screening, recruitment, testing, evaluation, and dissemination
procedures. Data collection, usage, and storage strictly adhere to national
laws, the General Data Protection Regulation (GDPR) of EU, and
APPI. Participants retain rights, such as access, information, withdrawal,
and data erasure. Additionally, servers are situated in the European
Union and comply with the GDPR standards. Data collection follows the
principle of data minimization, ensuring that personal information
collected is directly relevant and necessary for the specic goals of testing
and evaluation. Specic soware with blocks and data entry checks is
employed to minimize entry errors. All screening data are discarded
upon project completion. During testing procedures, any visual, auditory,
and sensory data processed by the robot are discarded aer completing
the procedures, except for the number of interactions logged with each
participant, which remains anonymous. Aer the conclusion of this
project, all research data will beopenly available for secondary analysis
aer 3 years.
Data analysis
A comprehensive analysis plan will beestablished to serve as the
foundation for conducting subsequent analyses. is plan will outline
the methodologies, procedures, and criteria for conducting the
analyses, ensuring a systematic and well-organized approach to data
interpretation and result generation.
Data collected by the researchers
e rst step of the data analysis will deal with the description of the
sample. Continuous variables will be reported as either mean and
standard deviation or median and interquartile range based on their
distribution (assessed using the Kolmogorov–Smirnov test). Categorical
variables will be expressed as an absolute number and percentage.
Comparison of baseline measurements between groups will beevaluated
by unpaired t-test (for normal distribution), Mann–Whitney U tests (for
non-normal distribution), or chi-square tests (for categorical variables).
Within each group, independent and dependent variables will
becompared between the pre-conditions and post-conditions using the
same tests as appropriate. e treatment eect on the outcome variables
will be evaluated by using repeated measures ANOVA, in order to
compare the changes over time in the outcome measures between the
intervention group and control group. Moreover, a linear regression
model on the outcome variation between baseline and follow-up will
beestimated in order to evaluate the eect of the treatment adjusted for
all potential confounders. For the analysis of the results, the two types of
subjects, stratied according to the MoCA cuto (score ≥ 26 for
cognitively healthy subjects, score 22 to 25 for subjects with mild
cognitive decline), will beconsidered separately. Descriptive statistical
analyses will beperformed on the quantitative data with SPSS or R studio.
Data collected by the technological devices
One of the uses of the data collected from the sensors is to infer
the activity of the user and know his or her location so that the voice
coach carries out personalized dialogs adapted to the contexts of the
user. e environmental data will be used to identify dangerous
situations and diculties and inform the user by giving him the right
recommendation to remedy this situation. e aggregation of activity
data from several testing centers will serve to motivate users and
strengthen their adherence to the experiment. e analysis of user
activity data and their interactions at well-dened milestones in the
experiment will make it possible to detect system failures as early as
possible, in order to prevent the user from dropping out.
Ethical consideration
e study received approval from the Ethics Committee of the
Istituto Nazionale Ricovero e Cura per Anziani (IRCCS INRCA) (CE
INRCA 23005), the German Association for Nursing Science
(Deutsche Gesellscha für Pegewissenscha e.V.) for the Diocesan
Caritas Association of the Archdiocese of Cologne, and the Research
Ethics Committee (Comité Ethique de la Recherche) for Assistance
Publique – Hôpitaux de Paris. It was registered in ClinicalTrials.gov
on 28 April 2023, with the number NCT05835856.
e study will beadhered to regulatory and legal requirements,
which were initiated aer receiving evaluation and approval from an
independent ethics committee and completing administrative
requirements at the conducting institution.
Additionally, all potentially eligible participants will receive
comprehensive information about the study and must provide consent
to participate.
Participants are required to consent to the processing of personal
data in anonymous and aggregate form, aligning with EU Regulation
2016/679 (GDPR)/APPI on the protection of individuals and
concerning the processing of personal data and Legislative Decree No.
101/2018. e participant must beinformed that his or her data may
beexamined by authorized personnel or members of the competent
ethics committee and ocials of the competent regulatory authorities;
e participant is also informed and asked to provide ad-hoc
informed consent to participate in the study, including data retention
for up to 10 or 15 years (depending on the country’s rules) aer
completion of the study.
Each signature must bepersonally dated by each signatory, and
the informed consent and any additional patient information must
beretained by the investigator. A signed copy of the informed consent
and information sheet will begiven to each patient.
Participant information and consent forms are included in the
documentation attached to the request for approval by the local
ethical committee.
[Optional] e Participant has the opportunity to indicate his or
her agreement to the retention and use of his or her data long aer the
end of the project under the OPEN ACCESS TO SCIENTIFIC
PUBLICATIONS AND OPEN RESEARCH DATA as requested by the
European Commission.
In the documentation submitted for approval by the IRCCS
INRCA Ethics Committee, patient information and consent forms
are integral components. These documents play a crucial role in
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ensuring that participants receive detailed information about the
study and have the opportunity to provide informed consent
before their involvement. This approach aligns with ethical
standards and regulatory requirements to safeguard participants’
rights and well-being.
Dissemination of research findings
The study findings will beutilized for publication in peer-
reviewed scientific journals, contributing to the academic and
research community’s knowledge. Additionally, the results will
be presented in scientific meetings, fostering discussions and
knowledge sharing within the academic and professional spheres.
Summaries of the outcomes will beprovided to investigators,
enabling them to disseminate key findings within their clinics,
further promoting the practical application of the study results in
relevant healthcare settings.
Discussion
In the face of an aging population, interventions are needed to
reduce or minimize the consequences of various diseases related to
advancing age (6), support the healthcare system, and promote active
aging, in which the senior is allowed to maintain their autonomy as
long as possible. One such solution has been identied in virtual
coaches (16) which, through a personalized system that constantly
keeps the senior constantly monitored (23) identify situations in
which it would bedesirable to intervene and propose to the user
dierent solutions and activities adapted to his or her needs and
requirements, allowing the person to maintain a healthy and active
lifestyle. Despite the advantages that these technologies bring, they
also have some limitations: in fact, there are several coaches of this
type, but it is obviously necessary for them to beperfectly integrated
into the lives of the older adults so that they take into account their
real needs that are also due to belonging to dierent cultures. It is
from this premise that the e-VITA project begins, in which dierent
technological devices were proposed to consider people’s actual
needs; the present study adopts a randomized, single-blind controlled
trial design to enlist healthy older adults aged 65 years and older. Its
primary objective is to assess the eectiveness of the e-VITA platform
in this demographic. is robust research design allows for rigorous
examination and comparison of outcomes, ensuring a comprehensive
evaluation of the platform’s impact on the health and well-being of
the participants. Participants will beselected from the four sites
described above. In this study, the primary goal is to assess the
improvement in the quality of life (QoL) of older individuals, which
was measured aer 6 months. To evaluate the eectiveness of the
treatment, the study population will bestratied into two groups. e
experimental group will engage with the e-VITA platform,
comprising a virtual coach, various monitoring sensors, a smartphone
for home use, and a booklet. In contrast, the control group will
receive the booklet alone. is design enables a comparative analysis,
allowing for the examination of the impact of the e-VITA platform
on enhancing the quality of life in older adults. e virtual coaching
system will detect daily physical, cognitive, psychological, and social
changes in the older person and provide useful advice and
recommendations accordingly. In this way, although the primary goal
is to improve the person’s quality of life, the system will also act on
other dimensions, such as mood, cognitive status, nutrition, social
connectedness, and eHealth literacy. In this study, the intervention
will beregularly monitored by the research team, which will conduct
evaluations in order to ensure its quality. In addition, researchers will
beconstantly over the call for any doubts or diculties from users to
support their motivation and participation in the trial.
Limitations
Participants will beselected from the Neurology Operating
Unit and the Rehabilitation Medicine Operating Unit of IRCCS
INRCA, so the results may not begeneralizable to the general
population. In addition, the e-VITA system is composed of
several types of technological equipment, which could be a
limitation for those older adults who, while meeting the inclusion
criteria, are not particularly familiar with these types of devices.
These problems could besolved by incorporating user-friendly
interfaces with clear and intuitive navigation to enhance ease of
use. In addition, comprehensive guides and tutorials could
bedeveloped to help participants familiarizing themselves with
the system. Moreover, users could attend training sessions to
beguided through initial set-up and use, to accommodate those
who may need further assistance.
Conclusion
The study aims to introduce users to a cross-cultural and
customizable virtual coach, which was designed to address
various aspects of the older person’s well-being, including social
relationships, physical activity, autonomy, and safety. The ultimate
goal is to enhance the overall quality of life for older individuals.
To rigorously assess the true potential and identify any potential
issues with the intervention, a randomized controlled trial is
deemed essential. This research design will provide valuable
insights into the effectiveness and challenges associated with the
implementation of the virtual coach in improving the well-being
of older adults.
Author contributions
RoB: Conceptualization, Methodology, Writing – original
draft, Writing – review & editing. VS: Conceptualization, Writing
– review & editing. GA: Data curation, Formal analysis, Writing
– review & editing. AM: Data curation, Writing – review &
editing. MB: Data curation, Writing – review & editing. FB: Data
curation, Formal analysis, Writing – review & editing. EM:
Methodology, Writing – original draft, Writing – review &
editing. A-SR: Conceptualization, Writing – review & editing. SC:
Writing – review & editing. CP: Conceptualization, Writing –
review & editing. JM: Conceptualization, Writing – review &
Bevilacqua et al. 10.3389/fpubh.2024.1256734
Frontiers in Public Health 17 frontiersin.org
editing. RyB: Conceptualization, Writing – review & editing. TO:
Conceptualization, Writing – review & editing. RW:
Conceptualization, Supervision, Writing – review & editing.
Funding
e author(s) declare nancial support was received for the
research, authorship, and/or publication of this article. is research
is based on data collected for the “EU-Japan Virtual Coach for Smart
Ageing - e-Vita” project funded by the European Union H2020
Program under grant agreement no. 101016453 and the Japanese
Ministry of Internal Aairs and Communication (MIC), Grant no.
JPJ000595.
Conflict of interest
e authors declare that the research was conducted in the
absence of any commercial or nancial relationships that could
beconstrued as a potential conict of interest.
Publisher’s note
All claims expressed in this article are solely those of the authors and
do not necessarily represent those of their aliated organizations, or
those of the publisher, the editors and the reviewers. Any product that
may be evaluated in this article, or claim that may be made by its
manufacturer, is not guaranteed or endorsed by the publisher.
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