NCT04899830

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.).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2024

Completed
Last Updated

March 6, 2026

Status Verified

February 1, 2020

Enrollment Period

3.2 years

First QC Date

May 10, 2021

Last Update Submit

March 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Evaluation of the a priori acceptability of robotic tele-interaction

    Day 0

  • Evaluation of the short-term acceptance of robotic tele-interaction

    At 1 month

  • Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.

    Day 0

  • Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.

    Day 0

  • Measure the effects of the use of the telepresence device on the patient's perception of his environment and his psycho-thymic state.

    Day 0

  • +7 more secondary outcomes

Study Arms (1)

Installation of a telepresence robot in the home of a disabled person hospitalized in a PRM center

EXPERIMENTAL

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,…)

Device: Telepresence robot

Interventions

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,…)

Installation of a telepresence robot in the home of a disabled person hospitalized in a PRM center

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CR Mulhouse

Mulhouse, Alsace, 68100, France

Location

IUR Clémenceau

Strasbourg, Alsace, 67000, France

Location

CMRRF de Kerpape

Ploemeur, Brittany Region, 56270, France

Location

CMPR Côte d'Amour

Saint-Nazaire, Pays de la Loire Region, 44600, France

Location

MeSH Terms

Conditions

Motor Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Thibaud Honoré, Doctor

    CMRRF de Kerpape

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 25, 2021

Study Start

October 24, 2020

Primary Completion

January 18, 2024

Study Completion

April 18, 2024

Last Updated

March 6, 2026

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations