Patient ParticipationSpringNCT05089799
" Socially Pertinent Robot in Gerontological Healthcare "
An observational study of Patient Participation and Patient Relations, Nurse, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Participation, Patient Relations, Nurse, Professional Role
- What is being tested?
- Exposure and interaction with a socially assistive robot
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2022to 25 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.).
Show all 15Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit
Paris, Île-de-France Region, 75013
About this study
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.
Read the 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.
- Being tested
- Exposure and interaction with a socially assistive robot
- Keywords
- Socially Assistive Robots, Gerontological Healthcare, acceptance, usability, organizational and ethic impact
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure and interaction with a socially assistive robotBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Patients | Older adults 60 years old or older They are referred to the day care hospital for memory problems or frailty and may present with various cognitive, behavioural, mental and physical disorders.
Persons in this group are diverse in socio-cultural levels. The investigators expect to include 100 patients (N = 100). Each patient will test 1 out of the 5 use cases, so 20 patients will test the same use case (n = 20). Receives: Behavioral: Exposure and interaction with a socially assistive robot | |
| Informal carers or family caregivers | This group includes persons who accompany patients during the hospital visit, such as family members (spouses or children) and friends.
They provide support to the patient with various frequency and intensity (occasional / regular / continuous).
Persons in this group are diverse in age and socio-cultural levels. They may also suffer from physical and/or psychological disorders.
The investigators expect to include 100 informal or family caregivers (N = 100). Each one will test 1 out of the 5 use cases, so 20 informal or family caregivers will test the same use case (n= 20). Receives: Behavioral: Exposure and interaction with a socially assistive robot | |
| Professionals | All categories of professionals working in the day care hospital. Persons in this group belong to different professional categories (administrative, health, technical). They have different levels of proximity with the public and have various positions in the hospital.
The investigators expect to include 50 professionals. Receives: Behavioral: Exposure and interaction with a socially assistive robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Inclusion visit
Secondary outcomes (3)
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.
Measured: Inclusion visit
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.
Measured: Inclusion visit
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.
Measured: Inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start20 Oct 2022
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient ParticipationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, Università degli Studi di Trento, Czech Technical University in Prague, Heriot-Watt University, ERM Automatismes Industriels (ERM), Pal Robotics SL (PAL), URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- RIGAUD Anne-Sophie, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089799
- Sponsor's protocol ID
- APHP201352
- Acronym
- Spring
- Status last verified
- Sep 2025
- First submitted
- 11 Oct 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The robot will process audio-visual data, using object, body and face localisation technologies as well as multi-microphone sound localisation to track objects and people and map the dynamics of its environment. The robot will also analyse facial features in order to decipher the emotional states of participants and trigger appropriate behaviour. However, the robot will not perform any profiling as defined by General Data Protection Regulation (GDPR): it will not process the data it collects in order to individualise or categorise a person. Furthermore, the robot's memory will be erased every night.
Publications
Blavette L, Dacunha S, Alameda-Pineda X, Hernandez Garcia D, Gannot S, Gras F, Gunson N, Lemaignan S, Polic M, Tandeitnik P, Tonini F, Rigaud AS, Pino M. Acceptability and Usability of a Socially Assistive Robot Integrated With a Large Language Model for Enhanced Human-Robot Interaction in a Geriatric Care Institution: Mixed Methods Evaluation. JMIR Hum Factors. 2025 Aug 1;12:e76496. doi: 10.2196/76496.
PubMed 40750072
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Socially Pertinent Robot in Gerontological Healthcare "
- ClinicalTrials.gov ID
- NCT05089799
- Acronym / sponsor ID
- Spring / APHP201352
- Keywords
- Socially Assistive Robots, Gerontological Healthcare, acceptance, usability, organizational and ethic impact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, Università degli Studi di Trento, Czech Technical University in Prague, Heriot-Watt University, ERM Automatismes Industriels (ERM), Pal Robotics SL (PAL), URC-CIC Paris Descartes Necker Cochin
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: Exposure and interaction with a socially assistive robotOlder adults 60 years old or older They are referred to the day care hospital for memory problems or frailty and may present with various cognitive, behavioural, mental and physical disorders. Persons in this group are diverse in socio-cultural levels. The investigators expect to include 100 patients (N = 100). Each patient will test 1 out of the 5 use cases, so 20 patients will test the same use case (n = 20). |
| Informal carers or family caregivers | – | Behavioral: Exposure and interaction with a socially assistive robotThis group includes persons who accompany patients during the hospital visit, such as family members (spouses or children) and friends. They provide support to the patient with various frequency and intensity (occasional / regular / continuous). Persons in this group are diverse in age and socio-cultural levels. They may also suffer from physical and/or psychological disorders. The investigators expect to include 100 informal or family caregivers (N = 100). Each one will test 1 out of the 5 use cases, so 20 informal or family caregivers will test the same use case (n= 20). |
| Professionals | – | Behavioral: Exposure and interaction with a socially assistive robotAll categories of professionals working in the day care hospital. Persons in this group belong to different professional categories (administrative, health, technical). They have different levels of proximity with the public and have various positions in the hospital. The investigators expect to include 50 professionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- PATIENTS
- Age 60 and over
- Enough knowledge in French language
- Without distinction of gender, socio-professional categories or ethnic origin
- MMSE > 10
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure and interaction with a socially assistive robotDescription of scenarios involving robot and users 1. welcoming patients and family members l: the robot explains its own functionalities and answers persons 'questions. 2. 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. 3. 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. 4. providing orientation and guidance to the consultation rooms and the available services : the robot helps people to find their way around the hospital. 5. Providing entertainment to patients and families during the waiting time: the robot offers activities to patients and caregivers | Behavioural | Informal carers or family caregivers, Patients, Professionals |
Primary outcome
Acceptability E-Scale (AE-S)
Time frame: Inclusion visit
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.
3 secondary outcomes
System Usability Scale (SUS)
Time frame: Inclusion visit
Semi-structured interview (10 questions) based on the USUS model (Hebesberger et al., 2017)
Time frame: Inclusion visit
Semi-structured interview (6 questions)
Time frame: Inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 40750072Blavette L, Dacunha S, Alameda-Pineda X, Hernandez Garcia D, Gannot S, Gras F, Gunson N, Lemaignan S, Polic M, Tandeitnik P, Tonini F, Rigaud AS, Pino M. Acceptability and Usability of a Socially Assistive Robot Integrated With a Large Language Model for Enhanced Human-Robot Interaction in a Geriatric Care Institution: Mixed Methods Evaluation. JMIR Hum Factors. 2025 Aug 1;12:e76496. doi: 10.2196/76496.
- The page presents the SPRING project and all the contributors of the project.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The robot will process audio-visual data, using object, body and face localisation technologies as well as multi-microphone sound localisation to track objects and people and map the dynamics of its environment. The robot will also analyse facial features in order to decipher the emotional states of participants and trigger appropriate behaviour. However, the robot will not perform any profiling as defined by General Data Protection Regulation (GDPR): it will not process the data it collects in order to individualise or categorise a person. Furthermore, the robot's memory will be erased every night.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RIGAUD Anne-Sophie principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Participation and Patient Relations, Nurse, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability E-Scale (AE-S) (time frame: Inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05089799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.