Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients

Motor Disorders Clinical Trial

— ROBOLINK-e  

Official title:

Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899830
• Other study ID #: 2019-A02088-49
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2023
• Source: Association APPROCHE
• Contact: Marie-Caroline Delebecque, CRA
• Phone: 0297826174
• Email: approche[@]mutualite29-56.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Disability
• Motor Disorders

Intervention

Device:
• Telepresence robot
From the application installed on a tablet, the patient hospitalized in a center for a period of at least 2 months can start from the center where he is hospitalized the mobile robotic telepresence assistance device installed at home to communicate with his family, his friends, his neighbors,…)

Locations

Country	Name	City	State
France	CR Mulhouse	Mulhouse	Alsace
France	CMRRF de Kerpape	Ploemeur	Bretagne
France	CMPR Côte d'Amour	Saint-Nazaire	Pays De La Loire
France	IUR Clémenceau	Strasbourg	Alsace

Sponsors (3)

Lead Sponsor	Collaborator
Association APPROCHE	COVEA, LP3C, University of Rennes 2

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the medium-term acceptance of robotic tele-interaction	Measured with hospitalized patients using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication)	At 2 months
Secondary	Evaluation of the a priori acceptability of robotic tele-interaction	Measured with hospitalized patients using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication). Measure of the a priori acceptability on Day 0. A priori acceptability corresponds to the study of representations of the user upstream of any use of the technology.	Day 0
Secondary	Evaluation of the short-term acceptance of robotic tele-interaction	Measured with hospitalized patients using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication). Measurement of acceptance at Day 30. The acceptance phase studies the user's judgment and impressions after the user's first interactions with the system	At 1 month
Secondary	Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.	This assessment is done using validated measurement scale relating to depression and anxiety: HAD scale (Hospital Anxiety and Depression). The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items graded from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21 ).To screen for anxiety and depressive symptoms, the following interpretation is used for each of the scores (A and D): - 7 or less: no symptoms - 8 to 10: doubtful symptomatology - 11 and over: definite symptomatology.	Day 0
Secondary	Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.	This assessment is done using validated measurement scale relating to psychological well-being: EBEP (Psychological Well-Being Scale). The Ryff scale of psychological well-being "is constructed from six key dimensions: autonomy, mastery of the environment, personal development, positive relationships, giving meaning to one's life and acceptance of life. self. It consists of 18 items sides 1 to 6, where 6 indicating strongly agree. A high total score indicates psychological well-being.	Day 0
Secondary	Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.	This assessment is done using validated measurement scale relating to quality of life: questionnaire general SF-36 (Short Form 36 Healt Survey). The SF-36 questionnaire is a multidimensional questionnaire that assesses quality of life in relation to health status, regardless of causal pathology, gender, age and treatment. It assesses functioning and overall well-being using a questionnaire using 36 questions divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality, functioning or social well-being, role limitations related to mental health, mental health).	Day 0
Secondary	Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.	This assessment is done using validated measurement scale relating to level of social participation: LHS scale (London Handicap Scale). This scale questions everyday life by assessing mobility, physical independence, occupation (work, hobbies, vacations, etc.), social integration, perception of the outside world and economic independence.; It takes the form of a questionnaire comprising 6 items rated from 0 to 1: - 1 = no handicap - 0 = maximum handicap.	Day 0
Secondary	Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.	This assessment is done using validated measurement scale relating to depression and anxiety: HAD scale (Hospital Anxiety and Depression). The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items graded from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21 ).To screen for anxiety and depressive symptoms, the following interpretation is used for each of the scores (A and D): - 7 or less: no symptoms - 8 to 10: doubtful symptomatology - 11 and over: definite symptomatology.	At 2 months
Secondary	Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.	This assessment is done using validated measurement scale relating to psychological well-being: EBEP (Psychological Well-Being Scale). The Ryff scale of psychological well-being "is constructed from six key dimensions: autonomy, mastery of the environment, personal development, positive relationships, giving meaning to one's life and acceptance of life. self. It consists of 18 items sides 1 to 6, where 6 indicating strongly agree. A high total score indicates psychological well-being.	At 2 months
Secondary	Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.	This assessment is done using validated measurement scale relating to quality of life: questionnaire general SF-36 (Short Form 36 Healt Survey). The SF-36 questionnaire is a multidimensional questionnaire that assesses quality of life in relation to health status, regardless of causal pathology, gender, age and treatment. It assesses functioning and overall well-being using a questionnaire using 36 questions divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality, functioning or social well-being, role limitations related to mental health, mental health).	At 2 months
Secondary	Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.	This assessment is done using validated measurement scale relating to level of social participation: LHS scale (London Handicap Scale). This scale questions everyday life by assessing mobility, physical independence, occupation (work, hobbies, vacations, etc.), social integration, perception of the outside world and economic independence.; It takes the form of a questionnaire comprising 6 items rated from 0 to 1: - 1 = no handicap - 0 = maximum handicap.	At 2 months
Secondary	Evaluation of the a priori acceptability of robotic tele-interaction for users, relatives and members of the multidisciplinary team	Measurement with categories of users around the patient and members of the multidisciplinary team, using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication). Measurement of a priori acceptability on Day 0. A priori acceptability corresponds to the study of representations of the user upstream of any use of the technology.	Day 0
Secondary	Evaluation of the medium-term acceptance of robotic tele-interaction for users, relatives and members of the multidisciplinary team	Measurement with categories of users around the patient and members of the multidisciplinary team, using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication). Measurement of acceptance at Day 60. The acceptance phase studies the user's judgment and impressions after the user's first interactions with the system.	At 2 months