Clinical trial NCT05835856: e-VITA: European-Japanese Virtual Coach for Smart Ageing (WAVE II)
Official title: e-VITA: European-Japanese Virtual Coach for Smart Ageing (WAVE II)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Older Adults
Quality of Life
Keywords: virtual coach
older adults
technological system
quality of life
usability
well-being
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2023-04-28
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Change in the Quality of Life
timeFrame: baseline and 6 months later
Secondary outcomes:
measure: Change in usability
timeFrame: At 3 and 6 months from baseline
measure: Change in frailty status
timeFrame: baseline and 6 months later
measure: Change in nutritional capacity
timeFrame: baseline and 6 months later
measure: Change in affinity with technology
timeFrame: baseline and 6 months later
measure: Change in cognitive status
timeFrame: baseline and 6 months later
measure: Change in psychological mood
timeFrame: baseline and 6 months later
measure: Change in performance status
timeFrame: baseline and 6 months later
measure: Change in person's need for technology
timeFrame: baseline and 6 months later
Other outcomes:
Locations:
city: Paris
country: France
facility: Broca Hospital
city: Cologne
country: Germany
facility: Diocesan Caritas Association for the Archdiocese of Cologne
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
city: Miyagi
country: Japan
facility: Tohoku University -Smart Ageing Research Center
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Roberta Bevilacqua
role: STUDY_DIRECTOR
References: