Chronic DiseaseVisio ETPNCT05378958
Qualitative Phenomenological Study on Videoconferencing Therapeutic Education
An observational study of Chronic Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Individual interview
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2022to 20 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Caregivers and participants practicing/have beneficiating of videoconferencing therapeutic education at Necker-Enfants Malades hospital.
Who may be able to join
- 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.
Who cannot join
- Lack of training (40 hours) in TPE for caregivers.
- ETP program not authorized or not declared to the Ile-de-France ARS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Phenomenological Study on Remote Therapeutic Education by Videoconferencing Crossing the Participant and Caregiver View
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.
Read more
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.
Read the detailed description
Chronic disease onset, due to its lasting and progressive nature, generates significant personal, family and socio-professional disabilities and difficulties. This situation requires active participation on the part of the patient, who must adopt protective behaviors in order to live better as much as possible.
Therapeutic patient education (TPE) is one of the mechanisms that will make patients 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 TPE programs were also impacted by the pandemic.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, without however defining clear recommendations for remote TPE. Several working groups have looked into remote TPE and recommendations have been issued in the form of practical advice 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. This new way of providing training required upstream preparation, reflection on the content, the use of digital tools and their mastery on the part of participants and speakers. The purpose of this qualitative study is to understand 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. The interviews will make it possible to better understand the effects of distant mode on therapeutic education sessions on participants but also on professional's practices. 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.
- Conditions
- Chronic Disease
- Being tested
- Individual interview
- Keywords
- Chronic disease, Therapeutic patient education, Pediatric therapeutic education, Videotherapeutic conferencing education, Understanding videoconferencing therapeutic education through lived experience, Recommendations on videoconferencing therapeutic education, Promotion of videoconferencing therapeutic education
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Any health professional (medical or paramedical profession) practicing therapeutic education in distance mode by videoconferencing, regardless of the programs concerned Receives: 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 Receives: Other: Individual interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (2)
Identify the particularities of distance therapeutic education and its success factors
Exploratory qualitative research of the lived experience of remote therapeutic education sessions by videoconference of participants and caregivers. Verbatim analysis of all the interviews, by the semio pragmatic phenomenology method, for identification of recurrences of theme to constitute a referencing of brakes and levers.
Measured: 18 months
Develop recommendations levers for videoconferencing therapeutic education
From the synthesis of all the data analyzed (verbatim interview analysed with semio pragmatic phenomelogy method, by answering the question : what will you advice a person who will provide remote therapeutic education ?) collect a framework of recommendations (practices from the field) to carry out a remote therapeutic education session intended for caregivers and taking into account the expectations and needs of the participants.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start20 Dec 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Why it stopped: Investigators were unable to begin and conduct the research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Cécile Godot, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisRadhia Dahmane, Study director, Assistance Publique - Hôpitaux de ParisThéo TENG, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378958
- Sponsor's protocol ID
- APHP220260
- Other IDs
- 2022-A00093-40
- Acronym
- Visio ETP
- Status last verified
- Mar 2024
- First submitted
- 2 May 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Phenomenological Study on Remote Therapeutic Education by Videoconferencing Crossing the Participant and Caregiver View
- ClinicalTrials.gov ID
- NCT05378958
- Acronym / sponsor ID
- Visio ETP / APHP220260
- Conditions
- Chronic Disease
- Keywords
- Chronic disease, Therapeutic patient education, Pediatric therapeutic education, Videotherapeutic conferencing education, Understanding videoconferencing therapeutic education through lived experience, Recommendations on videoconferencing therapeutic education, Promotion of videoconferencing therapeutic education
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigators were unable to begin and conduct the research.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic disease onset, due to its lasting and progressive nature, generates significant personal, family and socio-professional disabilities and difficulties. This situation requires active participation on the part of the patient, who must adopt protective behaviors in order to live better as much as possible.
Therapeutic patient education (TPE) is one of the mechanisms that will make patients 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 TPE programs were also impacted by the pandemic.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, without however defining clear recommendations for remote TPE. Several working groups have looked into remote TPE and recommendations have been issued in the form of practical advice 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. This new way of providing training required upstream preparation, reflection on the content, the use of digital tools and their mastery on the part of participants and speakers. The purpose of this qualitative study is to understand 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. The interviews will make it possible to better understand the effects of distant mode on therapeutic education sessions on participants but also on professional's practices. 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Other: Individual interviewAny health professional (medical or paramedical profession) practicing therapeutic education in distance mode by videoconferencing, regardless of the programs concerned |
| Participants | – | Other: Individual interview* 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 |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Caregivers and participants practicing/have beneficiating of videoconferencing therapeutic education at Necker-Enfants Malades hospital.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (2 listed)
- Lack of training (40 hours) in TPE for caregivers.
- ETP program not authorized or not declared to the Ile-de-France ARS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual interviewIndividual 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. | Other | Caregivers, Participants |
Primary outcome
Understanding of remote therapeutic education by videoconference
Time frame: 18 months
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.
2 secondary outcomes
Identify the particularities of distance therapeutic education and its success factors
Time frame: 18 months
Develop recommendations levers for videoconferencing therapeutic education
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Godot, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Radhia Dahmane study director
Assistance Publique - Hôpitaux de Paris
Théo TENG study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding of remote therapeutic education by videoconference (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.