Clinical trial NCT05089799: " Socially Pertinent Robot in Gerontological Healthcare "
Official title: " Socially Pertinent Robot in Gerontological Healthcare "
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Participation
Patient Relations, Nurse
Professional Role
Keywords: Socially Assistive Robots
Gerontological Healthcare
acceptance
usability
organizational and ethic impact
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche en Informatique et en Automatique
name: Università degli Studi di Trento
name: Czech Technical University in Prague
name: Heriot-Watt University
name: ERM Automatismes Industriels (ERM)
name: Pal Robotics SL (PAL)
First posted: 2021-10-22
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population includes the 3 categories of actors attending the day care hospital: patients, their carers (family or close carers) and professionals. The investigators will consider all the actors who are likely to interact with the ARI social robot, including people who are not formally part of the patients' care pathway, but whose presence is important to their care.

The individuals included will have various profiles, from a demographic, sociological and clinical point of view. The patients and their carers mainly live in the Paris region.

Patients mainly consult the day care hospital for memory problems, but are likely to display associated cognitive, behavioural or physical problems.

Brief summary: The SPRING project intends to develop a social assistance robot, called ARI, capable of interacting with several users (patients, families) in noisy and busy hospital environments to inform, guide and entertain them and to support care workers in these environments. The AP-HP researchers participating in the SPRING project wish to evaluate human-robot interactions in a day care hospital and in particular the acceptability and the uses of the robot.

Detailed description: Elderly people suffering from neurocognitive disorders require multimodal support (social, medical, associative) in which Socially Assistive Robots (SARs) could intervene in order to improve the physical and psychological well-being of elderly people and maintain their quality of life. SARs are social entities capable of interacting with their users in a variety of contexts (informational, recreational, educational). These robots also offer promising possibilities for accompanying care workers in their support of people with neurodegenerative diseases. However, up to date, these robots are not sufficiently sophisticated to engage in satisfactory social interactions with human beings and lead to their adoption.

The SPRING study is a non-interventional study that does not include objectives for improving health or patient care. It is an exploratory study targeting five use cases with a social robot and three populations of care hospital users (patients, informal or family caregivers and professionals). No follow-up of the participants is necessary.

The main objective of SPRING is to study the acceptability of socially assistive robots among three actors in a hospital service: patients, informal or family caregivers and professionals. The secondary objectives are to study a) the usability of the ARI robot among day care hospital's users which is necessary to understand the efficiency of using the robot in this context; b) the organisational impact of the robot on the operation of the service among day care hospital's professionals ; c) the ethical questions generated by the presence of the robot with the participants that will allow us to extend our understanding of the determinants of the rejection or adoption of new technologies in the hospital context.

During this non-interventional and exploratory research, the ARI robot will be tested in the waiting room of a day care hospital in a geriatric hospital regarding five use cases (1/welcoming patients and family members to the hospital, 2/ providing a reminder how to follow sanitary gestures for the prevention of virus transmission, 3/providing patients an assistance to prepare for the medical consultation that will follow during the day, 4/ providing orientation and guidance in relation to the location (hospital) and the services available (toilets, cafeteria, elevators, etc.) and 5/Providing entertainment to patients and families during the waiting time.

Patients and their family caregivers meet the robot only once. They answer questionnaires and participate in semi-structured interviews after interacting with the robot. Evaluations target the acceptability, usability and ethical issues raised by the presence of a robotic agent in support of care teams.

The professionals included in the study meet the robot several times according to their professional obligations (hospital practitioners are not present every day at the day care hospital and can choose when to interact with the robot). They will be invited to participate in two focus groups, one before the introduction of the robot and the other one at the end of the study. At the end of the study, the investigators will offer them to fill in questionnaires and participate in semi-structured interviews. The evaluations proposed to the professionals deal with questions of acceptability, usability, organisational impact of the robot's presence, and ethical issues related to its presence in the day care hospital.

Eligibility criteria: Inclusion Criteria:

* PATIENTS
* Age 60 and over
* Enough knowledge in French language
* Without distinction of gender, socio-professional categories or ethnic origin
* MMSE \> 10
* No symptoms of altered reality (delirium, hallucination, frontal disinhibition, etc.).
* Having expressed his/her non-opposition to his/her participation in the study or to being in the presence of the robot
* If the persons are protected adults under guardianship, the tutor or legal guardian has expressed his/her non-opposition to participate in the study or to be in the presence of the robot for the person concerned.
* ACCOMPANYING PERSONS
* They are all adults who have enough knowledge in French language.
* They are enrolled without distinction of gender, socio-professional categories or ethnic origin
* They have expressed his/her non-opposition to participate in the study
* PROFESSIONALS:
* Age 18 and over.
* Has expressed his/her non-opposition to participate in the study

Exclusion Criteria:

* PATIENTS
* They have expressed, or where applicable, their family, guardian or legal representative, their opposition to participate in the study or their opposition to be in the presence of the robot.
* PAtients benefiying of Medical State Aid (French AME)
* ACCOMPANYING PERSONS They are under 18. They do not have enough knowledge in French language to understand simple instructions. They have expressed their opposition to participate in the study or their opposition to be in the presence of the robot.
* PROFESSIONNALS They have expressed their opposition to participate in the study or their opposition to be in the presence of the robot.

Primary outcomes:
measure: Acceptability E-Scale (AE-S)
timeFrame: Inclusion visit
Secondary outcomes:
measure: System Usability Scale (SUS)
timeFrame: Inclusion visit
measure: Semi-structured interview (10 questions) based on the USUS model (Hebesberger et al., 2017)
timeFrame: Inclusion visit
measure: Semi-structured interview (6 questions)
timeFrame: Inclusion visit
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: RIGAUD Anne-Sophie
role: PRINCIPAL_INVESTIGATOR
References: