" Socially Pertinent Robot in Gerontological Healthcare "

Patient Participation Clinical Trial

— Spring  

Official title:

" Socially Pertinent Robot in Gerontological Healthcare "

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05089799
• Other study ID #: APHP201352
• Status: Recruiting
• Start date: October 20, 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: PINO Maribel, PhD, Research Engineer
• Phone: 00 33 1 44 08 33 51
• Email: maribel.pino[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patient Participation
• Patient Relations, Nurse
• Professional Role

Intervention

Behavioral:
• Exposure and interaction with a socially assistive robot
Description of scenarios involving robot and users welcoming patients and family members l: the robot explains its own functionalities and answers persons 'questions. providing a reminder about sanitary gestures (prevention of virus transmission). In addition, it could mediate a conversation between two or more people so that they keep the appropriate physical distance between them. providing patients with an assistance to prepare the medical consultations : the robot helps patients to fill in paper forms for professionals. The robot also provides information on the course of consultations and the users 'rights in the hospital. providing orientation and guidance to the consultation rooms and the available services : the robot helps people to find their way around the hospital. Providing entertainment to patients and families during the waiting time: the robot offers activities to patients and caregivers

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit	Paris	Ile De France

Sponsors (7)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ceske Vysoke Uceni Technicke V Praze (CVUT), ERM Automatismes Industriels (ERM), Heriot-Watt University, Institut National de Recherche en Informatique et en Automatique, Pal Robotics SL (PAL), Università degli Studi di Trento

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability E-Scale (AE-S)	This criterion will be evaluated with patients, informal or family caregivers and professionals, on the basis of the French version of the "Acceptability E-Scale" (AE-S), a six items questionnaire rated with a Likert scale from 1 to 5 (Micoulaud-Franchi et al., 2016). The items have been adapted for a use with a robot.; On the day of the appointment at the day care hospital for patients and their informal or family caregivers. During the experiment for professionals. One session, approximatively 10 minutes length.	Inclusion visit
Secondary	System Usability Scale (SUS)	The SUS is a 10 items questionnaire rated with a Likert scale from 1 to 5 (Brooke, 1996). Usability will also be evaluated with observations during interactions between participants and the robot.; On the day of the appointment at the day care hospital for patients and their carers. During the experiment for professionals. On session, approximatively, 15 minutes length.	Inclusion visit
Secondary	Semi-structured interview (10 questions) based on the USUS model (Hebesberger et al., 2017)	The organisational impactwill be evaluated with the professionals at the end of the experiment using a semi-structured interview (10 questions) based on the USUS model (Hebesberger et al., 2017).; During the experiment for professionals. One session, approximatively 15 minutes length.	Inclusion visit
Secondary	Semi-structured interview (6 questions)	Ethical aspects will be assessed by means of a semi-structured interview (6 questions) with day care hospital's users based on the ethical questions included in the acceptability questionnaire based on the UTAUT model (Alaiad & Zhou, 2014) and through an adaptation of some items of the "Ethical Acceptability Scale" (Peca, 2016).; On the day of the appointment at the day care hospital for patients and their carers. During the experiment for professionals. One session, approximatively 15 minutes length.	Inclusion visit

External Links

•   The page presents the SPRING project and all the contributors of the project.