Clinical trial NCT04899830: Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients
Official title: Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motor Disorders
Cognitive Disability
Lead sponsor: Association APPROCHE
Sponsor class: OTHER
Collaborators: name: LP3C, University of Rennes 2
name: COVEA
First posted: 2021-05-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study focuses on the mobile robot assist device for tele-interaction: the "COVEALINK 2" robot. This telepresence robot is designed for remote use inside the home. It works with an Internet connection (Wifi or 4G). It consists of a control interface (an application installed on the smartphone or tablet of the hospitalized patient) and a mobile robot placed in the home of the hospitalized patient (composed of a mobile platform, a visualization screen whose tilt is adjustable remotely for better adaptation to the interlocutors and an audio communication system). From the app installed on his smartphone or tablet, the patient hospitalized in the center for a long time (2 months minimum) will be able to start remotely (from the center where he is hospitalized) the robot and have it move within his home to communicate with the people present at the time of use (family, friends, neighbors etc.).


Eligibility criteria: Inclusion Criteria:

* Age ≧ 18 years old
* Affiliation to a social security scheme or beneficiary of such a scheme
* Having signed a free informed consent in writing
* Hospitalized in PRM for a foreseeable period of at least 60 days
* Living space compatible with the movement of the robot (verified by a home visit by the center's occupational therapist) and equipped with wifi
* Cognitive and motor functions compatible with the use of the tablet or phone independently, with learning capabilities to use the robot and the completion of questionnaires and interviews remotely
* Medically stable

Exclusion Criteria:

* Subject being in a period of exclusion from another protocol
* Mood and behavior disorders not stabilized
* Insufficient command of the French language
* Protected adults (guardianship / curatorship)
* Pregnant or breastfeeding women
* Persons deprived of their liberty
* Being unable to issue their consent
* Person who has already presented a form of addiction to technologies and / or video games

Primary outcomes:
measure: Evaluation of the medium-term acceptance of robotic tele-interaction
timeFrame: At 2 months
Secondary outcomes:
measure: Evaluation of the a priori acceptability of robotic tele-interaction
timeFrame: Day 0
measure: Evaluation of the short-term acceptance of robotic tele-interaction
timeFrame: At 1 month
measure: Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
timeFrame: Day 0
measure: Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
timeFrame: Day 0
measure: Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
timeFrame: Day 0
measure: Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
timeFrame: Day 0
measure: Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
timeFrame: At 2 months
measure: Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
timeFrame: At 2 months
measure: Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
timeFrame: At 2 months
measure: Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
timeFrame: At 2 months
measure: Evaluation of the a priori acceptability of robotic tele-interaction for users, relatives and members of the multidisciplinary team
timeFrame: Day 0
measure: Evaluation of the medium-term acceptance of robotic tele-interaction for users, relatives and members of the multidisciplinary team
timeFrame: At 2 months
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: CR Mulhouse
state: Alsace
city: Strasbourg
country: France
facility: IUR Clémenceau
state: Alsace
city: Ploemeur
country: France
facility: CMRRF de Kerpape
state: Bretagne
city: Saint-Nazaire
country: France
facility: CMPR Côte d'Amour
state: Pays De La Loire
Study officials:
affiliation: CMRRF de Kerpape
name: Thibaud Honoré, Doctor
role: PRINCIPAL_INVESTIGATOR
References: