An interventional study of Virtual coach with NAO robot and Virtual coach with Google Nest Hub (2e generation) group in Older Adults and Quality of Life, sponsored by Istituto Nazionale di Ricovero e Cura per Anziani. Active, not recruiting at 4 sites in 4 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Istituto Nazionale di Ricovero e Cura per Anziani · Not applicable, Interventional, and Other
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.
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:
These components (coaches, sensors, chatbot and social platform) together with a main software named Use Cases Configurator (UCC) constitute the Virtual Coach.
Istituto Nazionale di Ricovero e Cura per Anziani is the lead sponsor of 41 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Virtual coach with NAO robot
Device: Virtual coach with Google Nest Hub (2e generation) group
Device: Virtual coach with Gatebox device
Device: virtual coach with CelesTE robot
Other: booklet
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.
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.
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.
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.
Participant in the control group will receive a booklet containing information and activities on well-being
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.
Time frame: baseline and 6 months later
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'.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: baseline and 6 months later
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Istituto Nazionale di Ricovero e Cura per Anziani