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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Centre Leon Berard
  • Lyon, France
    • Centre Hospitalier Lyon Sud
  • Marseille, France, 13000
    • Institut Paoli Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Observation of communications between the hospitalised patient and his/her chid(children) by a specialist in human and social sciences	Through study completion, an average of 3 months
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	Interview with the hospitalised patient (parent) by a specialist in human and social sciences	Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the experience linked to the robot availability on the concerned persons (patient, children, person on charge of children)	Interview with the hospitalised patient (parent) and the person in charge of children by a specialist in human and social sciences	Through study completion, an average of 3 months
Evaluation of patient's satisfaction	Interview with the hospitalised patient (parent) and the person in charge of children by a specialist in human and social sciences	Through study completion, an average of 3 months
Evaluation of the impact of robot use on patient's coping strategies (adaptation and adjustment to illness and hospitalisation)	Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences	Through study completion, an average of 3 months
Evaluation of patient's experience of hospitalisation	Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences	Through study completion, an average of 3 months
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	Interview with the hospitalised patient and the person in charge of children by a specialist in human and social sciences	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: GUILLERMIN Yann, MD, Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): June 3, 2023
• Study Completion (Actual): June 3, 2023

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Long-term protective isolation; Patient-child relationship
• Other Study ID Numbers: ET19-193 - VIK-e2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No