NCT05089799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

October 11, 2021

Last Update Submit

September 5, 2025

Conditions

Keywords

Socially Assistive RobotsGerontological Healthcareacceptanceusabilityorganizational and ethic impact

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • System Usability Scale (SUS)

    Inclusion visit

  • Semi-structured interview (10 questions) based on the USUS model (Hebesberger et al., 2017)

    Inclusion visit

  • Semi-structured interview (6 questions)

    Inclusion visit

Study Arms (3)

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).

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).

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.

Behavioral: Exposure and interaction with a socially assistive robot

Interventions

Description 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

Informal carers or family caregiversPatientsProfessionals

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit

Paris, Île-de-France Region, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 40750072BACKGROUND

Related Links

MeSH Terms

Conditions

Patient Participation

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • RIGAUD Anne-Sophie

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 22, 2021

Study Start

October 20, 2022

Primary Completion

July 25, 2024

Study Completion

July 25, 2024

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The IPD collected by the robot will be available from the start of the study and kept for up to two years after the first publications.
Access Criteria
The data collected by the robot will be stored on a server at the AP-HP at BLL and then transmitted to INRIA engineers according to a secure transfer protocol with cryptographic method: End to end encryption (https, SSH, key/certificate authentication). The data will be transmitted to the SPRING project partners according to secure transfer and storage protocols, validated by the INRIA Defence Security Officer, to ensure the best conditions of confidentiality and security.

Locations