e-VITA: European-Japanese Virtual Coach for Smart Ageing (WAVE II)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Active, not recruiting

Conditions: Quality of Life; Older Adults

Treatments: Device: Virtual coach with Google Nest Hub (2e generation) group; Other: booklet; Device: Virtual coach with Gatebox device; Device: virtual coach with CelesTE robot; Device: Virtual coach with NAO robot

Study type: Interventional

Funder types: Other

Identifiers

NCT05835856

INRCA_005_2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 5 patient groups

NAO robot group

Experimental group

Treatment:

Device: Virtual coach with NAO robot

Google Nest Hub (2e generation) group

Experimental group

Treatment:

Device: Virtual coach with Google Nest Hub (2e generation) group

Gatebox group

Experimental group

Treatment:

Device: Virtual coach with Gatebox device

CelesTE robot group

Experimental group

Treatment:

Device: virtual coach with CelesTE robot

Control group

Other group

Treatment:

Other: booklet