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Study Evaluating the Parent-child Relationship During the Hospitalisation of a Parent in Long-term Protective Isolation (VIK-e2)

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ClinicalTrials.gov Identifier: NCT04856332
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Brief Summary:
The intensive treatments of certain cancers and haemopathies require the implementation of a protective isolation from external micro-organisms for a period of several weeks. This isolation implies a limitation of visitors and sometimes prohibits access to young children. This raises questions concerning the maintenance of family links, and in particular the parent-child relationship as well as the psychological and emotional isolation of hospitalised patients and the resulting psychological effects.

Condition or disease Intervention/treatment
Cancer Other: Telepresence robot installed at child's home during parent's hospitalisation

Detailed Description:

Telepresence robots are increasingly used as a means of remote communications, especially for teleconsultations and/or access to various public services (cultural events, education, etc.). In the context of long-term hospitalisation, they can be used for various purposes, such as access to cultural events, university activities, contact with patient's home and maintenance of family links. Some studies have analyzed the use of these robots and their effects in academic settings or the suitability of their use with elderly populations for continuing care.

To our knowledge, no study has evaluated the interest for the parent-child relationship of the use of a telepresence robot during the hospitalisation in protective isolation for a long period of a patient with young child(ren).

We propose to conduct this observational, multi-center prospective study aiming at evaluating the parent-child relationship following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: VIK-e2 - Observational, Multicenter Prospective Study Evaluating Parent-child Relationship With the Setting up of a Mobile Telepresence Robot for Patients With Children Aged 15 Years or Less and Hospitalised in Long-term Protective Isolation
Actual Study Start Date : February 24, 2021
Estimated Primary Completion Date : June 24, 2023
Estimated Study Completion Date : November 30, 2023

Intervention Details:
  • Other: Telepresence robot installed at child's home during parent's hospitalisation
    Telepresence robot installed at child's home during parent's hospitalisation in long term protective isolation for maintaining parent-child ink (only children aged 15 years or less are concerned)


Primary Outcome Measures :
  1. Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation [ Time Frame: Through study completion, an average of 3 months ]
    Observation of communications between the hospitalised patient and his/her chid(children) by a specialist in human and social sciences

  2. Evaluation of the use of a telepresence robot on the parent-child relationship in maintaining parenthood during parent's hospitalisation in long-term protective isolation [ Time Frame: Through study completion, an average of 3 months ]
    Interview with the hospitalised patient (parent) by a specialist in human and social sciences


Secondary Outcome Measures :
  1. Evaluation of the experience linked to the robot availability on the concerned persons (patient, children, person on charge of children) [ Time Frame: Through study completion, an average of 3 months ]
    Interview with the hospitalised patient (parent) and the person in charge of children by a specialist in human and social sciences

  2. Evaluation of patient's satisfaction [ Time Frame: Through study completion, an average of 3 months ]
    Interview with the hospitalised patient (parent) and the person in charge of children by a specialist in human and social sciences

  3. Evaluation of the impact of robot use on patient's coping strategies (adaptation and adjustment to illness and hospitalisation) [ Time Frame: Through study completion, an average of 3 months ]
    Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences

  4. Evaluation of patient's experience of hospitalisation [ Time Frame: Through study completion, an average of 3 months ]
    Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences

  5. Evaluation of the impact of the robot's presence at home on the children and the person in charge of the children during patient's hospitalisation [ Time Frame: Through study completion, an average of 3 months ]
    Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Observational prospective study, multicenter of parent-child relationship assessment following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation. This study is based on semi-directed interviews and observations made during patient's hospitalisation and when patient returns at home.
Criteria

Inclusion Criteria:

  • Age≥ 18
  • Patient with at least one child aged 15 or under
  • Pathology requiring a prolonged hospitalization in protective isolation
  • Consent dated and signed

Exclusion Criteria:

  • Impaired cognitive functions
  • Performance Status -Eastern Cooperative Oncology Group (PS-ECOG) = 4
  • Difficulties in speaking and understanding French
  • Patient under guardianship or curatorship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856332


Contacts
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Contact: METZGER Séverine +33 4.78.78.27.86 severine.metzger@lyon.unicancer.fr
Contact: GUILLERMIN Yann, MD +33 4.78.78.28.07 yann.guillermin@lyon.unicancer.fr

Locations
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France
Centre Leon Berard Recruiting
Lyon, France, 69008
Contact: GUILLERMIN Yann, MD       yann.guillermin@lyon.unicancer.fr   
Centre Hospitalier Lyon Sud Not yet recruiting
Lyon, France
Contact: GILIS Lila, MD       lila.gilis@chu-lyon.fr   
Institut Paoli Calmettes Not yet recruiting
Marseille, France, 13000
Contact: HOSPITAL Marie-Anne, MD    +33 4.91.22.37.54    hospitalm@ipc.unicancer.fr   
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: GUILLERMIN Yann, MD Centre Leon Berard
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT04856332    
Other Study ID Numbers: ET19-193 - VIK-e2
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Leon Berard:
Cancer
Long-term protective isolation
Patient-child relationship