Older AdultsNCT05835856
e-VITA: European-Japanese Virtual Coach for Smart Ageing (WAVE II)
A study testing Virtual coach with NAO robot, Virtual coach with Google Nest Hub (2e generation) group and Virtual coach with Gatebox device in people with Older Adults and Quality of Life, run by Istituto Nazionale di Ricovero e Cura per Anziani at 4 sites in 4 countries.
Trial summary
The study is a multicentre Proof-of-Concept. The general objective of the e-VITA project is to develop a personalized virtual coach capable of interacting with its elderly interlocutor. The experimentation will be carried out in 4 sites: Italy, France, Germany and Japan. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults, Quality of Life
- What is being tested?
- Virtual coach with NAO robot, Virtual coach with Google Nest Hub (2e generation) group and Virtual coach with Gatebox device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 24 Jul 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Able to stand and walk unaided;
- No acute or untreated medical problems;
- Montreal Cognitive Assessement test (MOCA) ≥ 22;
- Geriatric Depression Scale (GDS) < 9;
- Short performance physical battery (SPPB) ≥ 7
- Clinical Frailty Scale score between 2 and 4.
Who cannot join
- Use of active implant or not-implant medical devices;
- Allergy to nichel;
- A myocardial infarction or stroke within 6 months;
- Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility;
- Uncontrolled hypertension;
- Pacemaker or implantable cardioverter defibrillator;
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Germany1 site
Diocesan Caritas Association for the Archdiocese of Cologne
Cologne
About this study
The study is a multicentre Proof-of-Concept. The general objective of the e-VITA project is to develop a personalized virtual coach capable of interacting with its elderly interlocutor. The experimentation will be carried out in 4 sites: Italy, France, Germany and Japan.
Read the detailed description
The general objective of the e-VITA project is to improve well-being for older adults and thereby promote active and healthy ageing, contribute to independent living, and reduce risks of social exclusion of older adults by making use a virtual coach by 240 healthy older adults recruited from Europe (France, Germany and Italy) and Japan. The study is a multicenter Proof-of-Concept study with a duration of the intervention of six months.
The multidisciplinary consortium collaborating in this project will develop an innovative ICT-based virtual coaching system to detect subtle changes in physical, cognitive, psychological and social domains of older adult's daily life. The e-VITA virtual coach will thus provide personalized recommendations and interventions, for sustainable wellbeing in a smart living environment at home.
The different 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).
These components (coaches, sensors, chatbot and social platform) together with a main software named Use Cases Configurator (UCC) constitute the Virtual Coach.
- Conditions
- Older Adults, Quality of Life
- Being tested
- Virtual coach with NAO robot, Virtual coach with Google Nest Hub (2e generation) group, Virtual coach with Gatebox device, virtual coach with CelesTE robot, booklet
- Keywords
- virtual coach, older adults, technological system, quality of life, usability, well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual coach with NAO robotDevice
The coaching device used is the softbank NAO 5 and NAO 6 humanoid interactive mobile robot. These robot platform allows multimodal natural language interaction and robot autonomous movement.
Virtual coach with Google Nest Hub (2e generation) groupDevice
The coaching device used is Google Nest Hub (2e generation). This is a connected speaker enriched with a 7-chip touch screen. It has a loudspeaker and 3 microphones, making interaction possible.
Virtual coach with Gatebox deviceDevice
The coaching device used is the Gatebox, a hologram like device which the user can interact. There are 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 be connected to household appliances and other devices.
virtual coach with CelesTE robotDevice
The coaching device used is the CelesTE robot, a prayer companion designed for Christian Catholic users.The intended main function of CelesTE is to be a "guardian angel", especially thought for elderly people. It can be a 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.
The coaching device CelesTE will be substituted by DarumaTO for the Japanese centers.
bookletOther
Participant in the control group will receive a booklet containing information and activities on well-being
| Study group | Role | What they receive |
|---|---|---|
| NAO robot group | Experimental | Not described Receives: Device: Virtual coach with NAO robot |
| Google Nest Hub (2e generation) group | Experimental | Not described Receives: Device: Virtual coach with Google Nest Hub (2e generation) group |
| Gatebox group | Experimental | Not described Receives: Device: Virtual coach with Gatebox device |
| CelesTE robot group | Experimental | Not described Receives: Device: virtual coach with CelesTE robot |
| Control group | Other | Not described Receives: Other: booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Quality of Life
The EQ-5D-5L scale consists of five dimensions: mobility, independence, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 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 be combined into a 5-digit number that describes the health status of the participant.
Measured: baseline and 6 months later
Secondary outcomes (8)
Change in usability
The System Usability Scale (SUS) is a reliable tool for measuring usability. It consists of a10 item questionnaire with five response options for respondents from 'Strongly agree' to 'Strongly disagree'.
Measured: At 3 and 6 months from baseline
Change in frailty status
The Clinical Frailty Scale (CFS) divides the older participants into 9 classes based on the information provided by them and their relatives: between 1 and 3 the patient is non-frail, pre-frail if 4, he is frail from 5 to 9.
Measured: baseline and 6 months later
Change in nutritional capacity
The Short Food frequency questionnaires scale (FFQ) is used to estimate the frequency of daily food intake over a period of time. The FFQ asks for the frequency of certain food intake (once daily, once or twice a week, once or twice a month), and the approximate serving size. The questionnaire asks for information on the habitual intake of the food and is not to quantify the actual amount of nutrients ingested.
Measured: baseline and 6 months later
Change in affinity with technology
The Affinity for Technology Interaction (ATI) measures a person's interaction-related affinity with technology. It consists of a total of nine items and uses a six-point Likert scale from 1 = completely disagree to 6 = completely agree.
Measured: baseline and 6 months later
Change in cognitive status
Montreal Cognitive Assessment (MoCA) is a cognitive test validated as a highly sensitive tool for early detection of mild cognitive impairment (MCI). Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.
Measured: baseline and 6 months later
Change in psychological mood
The Geriatric Depression scale 5-items version (GDS-5 items) questionnaire assesses the current condition of the patient's mood. Scores >1 are indicative for depression.
Measured: baseline and 6 months later
Change in performance status
Short Physical Performance Battery (SPPB) is a short battery of tests designed to assess the function of the lower limbs. This scale consists of 3 different sections: balance assessment, evaluation of walking on 4 linear meters, evaluation of the ability to perform, for 5 consecutive times, the sit to stand from a chair, without using the upper limbs. The total scale score therefore has a range from 0 to 12. A total score below 10 indicates frailty and a high risk of disability and falls.
Measured: baseline and 6 months later
Change in person's need for technology
The Assistive Technology Device Predisposition Assessment (ATDPA-5 - scales B and E) 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. These first 20 items are to be filled in on a Likert scale of 5, ranging from 1: poor/not satisfied to 5: excellent/very satisfied. Finally, this last part also assesses personal and psychosocial characteristics. There is no threshold value for these last items. The second part deals with technological tools with 12 items highlighting their expectations in terms of benefits towards three technological tools. There is no threshold for this scale, but the scores range from 0 to 60 (sum of the statements).
Measured: baseline and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start24 Jul 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Roberta Bevilacqua, Study director, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835856
- Sponsor's protocol ID
- INRCA_005_2023
- Status last verified
- Oct 2023
- First submitted
- 18 Apr 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-VITA: European-Japanese Virtual Coach for Smart Ageing (WAVE II)
- ClinicalTrials.gov ID
- NCT05835856
- Acronym / sponsor ID
- INRCA_005_2023
- Conditions
- Older Adults, Quality of Life
- Keywords
- virtual coach, older adults, technological system, quality of life, usability, well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a multicentre Proof-of-Concept. The general objective of the e-VITA project is to develop a personalized virtual coach capable of interacting with its elderly interlocutor. The experimentation will be carried out in 4 sites: Italy, France, Germany and Japan.
Detailed description
The general objective of the e-VITA project is to improve well-being for older adults and thereby promote active and healthy ageing, contribute to independent living, and reduce risks of social exclusion of older adults by making use a virtual coach by 240 healthy older adults recruited from Europe (France, Germany and Italy) and Japan. The study is a multicenter Proof-of-Concept study with a duration of the intervention of six months.
The multidisciplinary consortium collaborating in this project will develop an innovative ICT-based virtual coaching system to detect subtle changes in physical, cognitive, psychological and social domains of older adult's daily life. The e-VITA virtual coach will thus provide personalized recommendations and interventions, for sustainable wellbeing in a smart living environment at home.
The different 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).
These components (coaches, sensors, chatbot and social platform) together with a main software named Use Cases Configurator (UCC) constitute the Virtual Coach.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NAO robot group | Experimental | Device: Virtual coach with NAO robot |
| Google Nest Hub (2e generation) group | Experimental | Device: Virtual coach with Google Nest Hub (2e generation) group |
| Gatebox group | Experimental | Device: Virtual coach with Gatebox device |
| CelesTE robot group | Experimental | Device: virtual coach with CelesTE robot |
| Control group | Other | Other: booklet |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Able to stand and walk unaided;
- No acute or untreated medical problems;
- Montreal Cognitive Assessement test (MOCA) ≥ 22;
- Geriatric Depression Scale (GDS) < 9;
- Short performance physical battery (SPPB) ≥ 7
Key exclusion criteria (6 listed)
- Use of active implant or not-implant medical devices;
- Allergy to nichel;
- A myocardial infarction or stroke within 6 months;
- Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility;
- Uncontrolled hypertension;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual coach with NAO robotThe coaching device used is the softbank NAO 5 and NAO 6 humanoid interactive mobile robot. These robot platform allows multimodal natural language interaction and robot autonomous movement. | Device | NAO robot group |
| Virtual coach with Google Nest Hub (2e generation) groupThe coaching device used is Google Nest Hub (2e generation). This is a connected speaker enriched with a 7-chip touch screen. It has a loudspeaker and 3 microphones, making interaction possible. | Device | Google Nest Hub (2e generation) group |
| Virtual coach with Gatebox deviceThe coaching device used is the Gatebox, a hologram like device which the user can interact. There are 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 be connected to household appliances and other devices. | Device | Gatebox group |
| virtual coach with CelesTE robotThe coaching device used is the CelesTE robot, a prayer companion designed for Christian Catholic users.The intended main function of CelesTE is to be a "guardian angel", especially thought for elderly people. It can be a 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. The coaching device CelesTE will be substituted by DarumaTO for the Japanese centers. | Device | CelesTE robot group |
| bookletParticipant in the control group will receive a booklet containing information and activities on well-being | Other | Control group |
Primary outcome
Change in the Quality of Life
Time frame: baseline and 6 months later
The EQ-5D-5L scale consists of five dimensions: mobility, independence, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 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 be combined into a 5-digit number that describes the health status of the participant.
8 secondary outcomes
Change in usability
Time frame: At 3 and 6 months from baseline
Change in frailty status
Time frame: baseline and 6 months later
Change in nutritional capacity
Time frame: baseline and 6 months later
Change in affinity with technology
Time frame: baseline and 6 months later
Change in cognitive status
Time frame: baseline and 6 months later
Change in psychological mood
Time frame: baseline and 6 months later
Change in performance status
Time frame: baseline and 6 months later
Change in person's need for technology
Time frame: baseline and 6 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta Bevilacqua study director
IRCCS INRCA, Ancona, Italy
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual coach with NAO robot, Virtual coach with Google Nest Hub (2e generation) group and Virtual coach with Gatebox device in people with Older Adults and Quality of Life, run by Istituto Nazionale di Ricovero e Cura per Anziani at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Italy, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Quality of Life (time frame: baseline and 6 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.