NCT05378958

Brief Summary

Therapeutic patient education (TPE) is one of the mechanisms that make patients with chronic disease as competent as possible to manage illness and treatment by helping them to be autonomous and responsible for their decision-making. The COVID-19 pandemic has changed the organization of care, prioritizing the emergency fight against the epidemic. The French High Authority of Health (HAS) has recommended maintaining individual TPE sessions by videoconference or telephone, based on the usual stages of the educational process. Several working groups have looked into remote TPE and recommendations have been issued in the form of practical advice but without questioning the participants, who did not participate in the reflection. No consensus, including health authorities, has been reached on this subject. At Necker Hospital, ETPs were carried out remotely, by videoconference. Understanding remote therapeutic education by videoconference through lived experience, by means of a one-hour interview, of the caregivers who deliver it and the parents of patients or the patients who receive it, will make it possible to better understand the effects of remote mode on therapeutic education sessions but also on professional practices and on participants. The benefit will be twofold: for caregivers: to facilitate the deployment of this new educational offer. For patients and their carers: give priority access to TPE to families who are far from the healthcare system or to patients who are too fragile to travel and thus reduce inequalities and geographical barriers.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

December 20, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

September 25, 2025

Status Verified

March 1, 2024

Enrollment Period

Same day

First QC Date

May 2, 2022

Last Update Submit

September 22, 2025

Conditions

Keywords

Chronic diseaseTherapeutic patient educationPediatric therapeutic educationVideotherapeutic conferencing educationUnderstanding videoconferencing therapeutic education through lived experienceRecommendations on videoconferencing therapeutic educationPromotion of videoconferencing therapeutic education

Outcome Measures

Primary Outcomes (1)

  • Understanding of remote therapeutic education by videoconference

    Exploratory qualitative research of the lived experience of remote therapeutic education sessions by videoconference (phenomena) by interviewing participants and caregivers. Verbatim analysis of interviews by phenomenological qualitative method : collection, organization, and interpretation of textual material derived from talk or conversation to understand the phenomena and its meaning. The purpose of this approach is to bring out the categories of the phenomenon studied, each category representing a dimension of the phenomenon studied.

    18 months

Secondary Outcomes (2)

  • Identify the particularities of distance therapeutic education and its success factors

    18 months

  • Develop recommendations levers for videoconferencing therapeutic education

    24 months

Study Arms (2)

Caregivers

Any health professional (medical or paramedical profession) practicing therapeutic education in distance mode by videoconferencing, regardless of the programs concerned

Other: Individual interview

Participants

* Patient's caregivers or parents who have taken part in a therapeutic education session by videoconference (individual or collective) as part of a program, regardless of their age, sex or the pathology concerned by education program * Patients: from 10 years old and only if the therapeutic education session was intended for them, regardless of gender or pathology

Other: Individual interview

Interventions

Individual semi-directed explication interview with phenomenological questioning centered on lived experience. The individual interview aims to collect data by questioning the participants using interview communication techniques, essentially on the "reformulation" technique. The interview is structured using an interview guide containing the list of open questions with prompts to be answered during the discussion.

CaregiversParticipants

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Caregivers and participants practicing/have beneficiating of videoconferencing therapeutic education at Necker-Enfants Malades hospital.

You may qualify if:

  • Understanding of the French language (oral and written) for all participants.
  • Information and non-opposition of the subjects and of holders of parental authority of minor subjects.
  • Caregivers: any health professional practicing videoconferencing therapeutic education can be included without age limit, regardless of gender, profession exercised (medical or paramedical) or the program concerned as long as the program is authorized (or declared) to authorized by the Ile-de-France Regional Health Agency (ARS).
  • Participants: depending on the age of the patients, parents can be the exclusive target of therapeutic education (especially for young patients) or be present with their child during the sessions. The participants are the beneficiaries of therapeutic education either:
  • Parents/caregivers who have taken part in a videoconferencing TPE session (individual or collective) as part of a program authorized by the Ile-de-France ARS, regardless of their age, sex or the pathology concerned in the education program.
  • Patients: from 10 years old and only if the videoconferencing therapeutic education session was intended for them, regardless of gender or pathology.

You may not qualify if:

  • Lack of training (40 hours) in TPE for caregivers.
  • ETP program not authorized or not declared to the Ile-de-France ARS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cécile Godot, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Radhia Dahmane

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR
  • Théo TENG

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 18, 2022

Study Start

December 20, 2022

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

September 25, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations