Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients (ROBOLINK-e)
Primary Purpose
Motor Disorders, Cognitive Disability
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Telepresence robot
Sponsored by
About this trial
This is an interventional other trial for Motor Disorders
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
Sites / Locations
- CR MulhouseRecruiting
- IUR Clémenceau
- CMRRF de KerpapeRecruiting
- CMPR Côte d'AmourRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Installation of a telepresence robot in the home of a disabled person hospitalized in a PRM center
Arm Description
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,…)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
Full Information
NCT ID
NCT04899830
First Posted
May 10, 2021
Last Updated
February 7, 2023
Sponsor
Association APPROCHE
Collaborators
LP3C, University of Rennes 2, COVEA
1. Study Identification
Unique Protocol Identification Number
NCT04899830
Brief Title
Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients
Acronym
ROBOLINK-e
Official Title
Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2020 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association APPROCHE
Collaborators
LP3C, University of Rennes 2, COVEA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Disorders, Cognitive Disability
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Installation of a telepresence robot in the home of a disabled person hospitalized in a PRM center
Arm Type
Experimental
Arm Description
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,…)
Intervention Type
Device
Intervention Name(s)
Telepresence robot
Intervention Description
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,…)
Primary Outcome Measure Information:
Title
Evaluation of the medium-term acceptance of robotic tele-interaction
Description
Measured with hospitalized patients using questionnaires developed by the LP3C (Laboratory of Psychology, Cognition, Behavior, Communication)
Time Frame
At 2 months
Secondary Outcome Measure Information:
Title
Evaluation of the a priori acceptability of robotic tele-interaction
Description
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.
Time Frame
Day 0
Title
Evaluation of the short-term acceptance of robotic tele-interaction
Description
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
Time Frame
At 1 month
Title
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Description
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.
Time Frame
Day 0
Title
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Description
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.
Time Frame
Day 0
Title
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Description
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).
Time Frame
Day 0
Title
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Description
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.
Time Frame
Day 0
Title
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Description
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.
Time Frame
At 2 months
Title
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Description
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.
Time Frame
At 2 months
Title
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Description
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).
Time Frame
At 2 months
Title
Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.
Description
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.
Time Frame
At 2 months
Title
Evaluation of the a priori acceptability of robotic tele-interaction for users, relatives and members of the multidisciplinary team
Description
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.
Time Frame
Day 0
Title
Evaluation of the medium-term acceptance of robotic tele-interaction for users, relatives and members of the multidisciplinary team
Description
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.
Time Frame
At 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Caroline Delebecque, CRA
Phone
0297826174
Ext
+33
Email
approche@mutualite29-56.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Coignard, Doctor
Phone
0297826060
Ext
+33
Email
pauline.coignard@mutualite29-56.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thibaud Honoré, Doctor
Organizational Affiliation
CMRRF de Kerpape
Official's Role
Principal Investigator
Facility Information:
Facility Name
CR Mulhouse
City
Mulhouse
State/Province
Alsace
ZIP/Postal Code
68100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mélanie Fimbel
Phone
03 89 32 4646
Email
mfimbel@arfp.asso.fr
First Name & Middle Initial & Last Name & Degree
Anne Passadori, Doctor
Facility Name
IUR Clémenceau
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CMRRF de Kerpape
City
Ploemeur
State/Province
Bretagne
ZIP/Postal Code
56270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Caroline Delebecque, CRA
Phone
0297826174
Email
approche@mutualite29-56.fr
First Name & Middle Initial & Last Name & Degree
Thibaud Honoré, Doctor
First Name & Middle Initial & Last Name & Degree
Jean-Luc Le Guiet, Doctor
Facility Name
CMPR Côte d'Amour
City
Saint-Nazaire
State/Province
Pays De La Loire
ZIP/Postal Code
44600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine Mathieu
Phone
02 40 00 01 00
Email
cmpr-ergo@association-penbron.fr
First Name & Middle Initial & Last Name & Degree
Hélène Joly Jehenne
Phone
02 40 00 01 00
Email
cmpr-ergo@association-penbron.fr
First Name & Middle Initial & Last Name & Degree
Matthieu Gahier, Doctor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients
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