Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT05378958
Status:
WITHDRAWN
Last Update Posted:
2025-09-25
First Post:
2022-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Qualitative Phenomenological Study on Videoconferencing Therapeutic Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Investigators were unable to begin and conduct the research.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2022-05-02', 'studyFirstSubmitQcDate': '2022-05-12', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Understanding of remote therapeutic education by videoconference', 'timeFrame': '18 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Identify the particularities of distance therapeutic education and its success factors', 'timeFrame': '18 months', 'description': '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.'}, {'measure': 'Develop recommendations levers for videoconferencing therapeutic education', 'timeFrame': '24 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Chronic Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nThe COVID-19 pandemic has changed the organization of care, prioritizing the emergency fight against the epidemic.\n\nThe 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.\n\nAt 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.\n\nThe 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.', 'detailedDescription': "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.\n\nTherapeutic 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.\n\nThe 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.\n\nAt 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caregivers and participants practicing/have beneficiating of videoconferencing therapeutic education at Necker-Enfants Malades hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Understanding of the French language (oral and written) for all participants.\n* Information and non-opposition of the subjects and of holders of parental authority of minor subjects.\n* 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).\n* 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:\n\n * 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.\n * Patients: from 10 years old and only if the videoconferencing therapeutic education session was intended for them, regardless of gender or pathology.\n\nExclusion Criteria:\n\n* Lack of training (40 hours) in TPE for caregivers.\n* ETP program not authorized or not declared to the Ile-de-France ARS.'}, 'identificationModule': {'nctId': 'NCT05378958', 'acronym': 'Visio ETP', 'briefTitle': 'Qualitative Phenomenological Study on Videoconferencing Therapeutic Education', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Qualitative Phenomenological Study on Remote Therapeutic Education by Videoconferencing Crossing the Participant and Caregiver View', 'orgStudyIdInfo': {'id': 'APHP220260'}, 'secondaryIdInfos': [{'id': '2022-A00093-40', 'type': 'OTHER', 'domain': 'IDRCB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caregivers', 'description': 'Any health professional (medical or paramedical profession) practicing therapeutic education in distance mode by videoconferencing, regardless of the programs concerned', 'interventionNames': ['Other: Individual interview']}, {'label': 'Participants', 'description': "* 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\n* Patients: from 10 years old and only if the therapeutic education session was intended for them, regardless of gender or pathology", 'interventionNames': ['Other: Individual interview']}], 'interventions': [{'name': 'Individual interview', 'type': 'OTHER', 'description': 'Individual semi-directed explication interview with phenomenological questioning centered on lived experience.\n\nThe 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.', 'armGroupLabels': ['Caregivers', 'Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Cécile Godot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Radhia Dahmane', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Théo TENG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}