Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-09 @ 3:27 AM
Study NCT ID:
NCT03641261
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2018-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Education Using an Internet Application in Hereditary Ichthyosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007057', 'term': 'Ichthyosis'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global use', 'timeFrame': '6 months', 'description': 'percentage of patients who have used the "WebIchtyose" application for at least 8 hours during 6 months'}], 'secondaryOutcomes': [{'measure': 'Fractional use in each domain (educational sessions)', 'timeFrame': '6 months', 'description': '"WebIchtyose" application use time by the patient for group and individual educational sessions'}, {'measure': 'Fractional use in each domain (continuous educational follow-up)', 'timeFrame': '6 months', 'description': '"WebIchtyose" application use time by the patient for the continuous educational follow-up'}, {'measure': 'Fractional use in each domain (consultation)', 'timeFrame': '6 months', 'description': '"WebIchtyose" application use time by the patient for the consultation of the "Frequently Asked Questions" area and of patient information documents made available on the application'}, {'measure': 'Fractional use in each domain (questionnaires)', 'timeFrame': '6 months', 'description': '"WebIchtyose" application use time by the patient for the filling of the questionnaires'}, {'measure': 'Fractional use in each domain', 'timeFrame': '6 months', 'description': '"WebIchtyose" application use time by the patient for group and individual educational sessions, the continuous educational follow-up, the consultation of the "Frequently Asked Questions" area and of patient information documents made available on the application'}, {'measure': 'Difficulty of individual application registration', 'timeFrame': 'Baseline', 'description': 'Difficulty of registration questionnaire completed for each patient jointly by the patient and the educational team at the end of the face-to-face inclusion visit'}, {'measure': 'Difficulties of use in everyday life by the patient', 'timeFrame': '6 months', 'description': 'Questionnaire completed for each patient jointly by the patient at the end of the program'}, {'measure': 'Number of exchanges', 'timeFrame': '3 months and 5 months', 'description': 'Number of exchanges necessary between the educational team and the patient to set a date for the conduct of the individual educational sessions'}, {'measure': 'Response time', 'timeFrame': '6 months', 'description': 'Response time of the educational team following a request from the patient as part of the educational follow-up'}, {'measure': 'Number of relaunches', 'timeFrame': '2 months, 4 months and 6 months', 'description': 'How many times the nurse relaunches the patient to obtain the assessment questionnaires'}, {'measure': 'Number of non-received questionnaires', 'timeFrame': '2 months, 4 months and 6 months', 'description': 'Number of non-received questionnaires after relaunch'}, {'measure': 'Number of lost to follow-up patients', 'timeFrame': '9 months', 'description': 'Number of lost to follow-up patients'}, {'measure': 'Patient acceptability', 'timeFrame': '6 months', 'description': 'Acceptability questionnaire to be completed by the patient'}, {'measure': 'Educational team acceptability', 'timeFrame': '6 months', 'description': 'Acceptability questionnaire to be completed by each member of the educational team'}, {'measure': 'Attractiveness', 'timeFrame': '6 months', 'description': 'Application attractiveness questionnaire completed by the patient'}, {'measure': 'Quality of life before and after treatment', 'timeFrame': 'Inclusion, 6 months and 9 months', 'description': 'Quality of life questionnaire for hereditary ichthyosis (IQoL-32)'}, {'measure': 'Self-assessment of cutaneous severity', 'timeFrame': 'Inclusion and 6 months', 'description': 'Self-assessment of cutaneous severity according to an analogic visual scale for pain, pruritus, erythema, squama'}, {'measure': 'Knowledge about disease and treatments', 'timeFrame': 'Inclusion and 6 months', 'description': 'Questionnaire of knowledge about disease and treatments'}, {'measure': 'Self-care skills', 'timeFrame': 'Inclusion and 6 months', 'description': 'Questionnaire of self-care skills'}, {'measure': 'Self-esteem', 'timeFrame': 'Inclusion and 6 months', 'description': 'Questionnaire about self-esteem: Rosenberg scale. For each item of the questionnaire, the modality answers are : 1 (totally disagree), 2 (quite disagree), 3 (quite agree) and 4 (totally disagree). The total score (/ 40) is calculated by adding the scores obtained for each item.'}, {'measure': 'Coping scale', 'timeFrame': 'Inclusion and 6 months', 'description': 'Coping with health injuries and problem (Endler 1998). For each item of the questionnaire, the modality answers are: 1 (not at all), 2 (a little), 3 (moderately), 4 (often) and 5 (a lot).The total score (/ 160) is calculated by adding the scores obtained for each item.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hereditary ichthyosis'], 'conditions': ['Ichthyosis']}, 'descriptionModule': {'briefSummary': 'The main purpose is to evaluate the feasibility (global use) of a therapeutic patient education program using a specific web application in patients with hereditary ichthyosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with hereditary ichthyosis, according to the classification established during the 2009 consensus conference\n* Who has given his informed consent form\n* Who is affiliated to a social security system\n\nExclusion Criteria:\n\n* Patient who has already participated in a therapeutic patient education program for the hereditary ichthyosis\n* Unable to connect or use a computer tool\n* Impossibility to be present at the only face-to-face session\n* Patient who is not available for the collective educational session\n* Patient with little or no motivation to follow a therapeutic patient education program (motivation evaluated by the educational team by phone call before inclusion)\n* Patient not mastering the French language\n* Person under legal protection (guardianship, curators or safeguard of justice)'}, 'identificationModule': {'nctId': 'NCT03641261', 'acronym': 'e-ETPichtyose', 'briefTitle': 'Therapeutic Education Using an Internet Application in Hereditary Ichthyosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Evaluation of the Feasibility and Effect of Therapeutic Education Sessions Using an Internet Application in Hereditary Ichthyosis', 'orgStudyIdInfo': {'id': 'RC31/16/8765'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Patient Education program', 'description': 'All included patients will follow a Therapeutic Patient Education program dedicated to the hereditary ichthyosis and using a web application, WebIchtyose', 'interventionNames': ['Other: Therapeutic patient education program']}], 'interventions': [{'name': 'Therapeutic patient education program', 'type': 'OTHER', 'otherNames': ['WebIchtyose'], 'description': 'WebIchtyose is a specific therapeutic patient education program for patients with hereditary Ichthyosis targeting the problems of each patient by means of a personalized follow-up and a constant interaction between the patient and the educational team', 'armGroupLabels': ['Therapeutic Patient Education program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse, Hôpital Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Juliette Mazereeuw-Hautier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}