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

February 26, 2025 updated by: Centre Leon Berard

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Lyon, France
        • Centre Hospitalier Lyon Sud
      • Marseille, France, 13000
        • Institut Paoli Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
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
Time Frame: Through study completion, an average of 3 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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
Through study completion, an average of 3 months
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
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)
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
Through study completion, an average of 3 months
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
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
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
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Leon Berard

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: GUILLERMIN Yann, MD, Centre Léon Bérard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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