Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-01 @ 11:03 AM
Study NCT ID:
NCT02122432
Status:
COMPLETED
Last Update Posted:
2015-06-22
First Post:
2014-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Teledermatology Versus Usual Care on Delay Before Diagnosis and Treatment of Dermatologic Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-19', 'studyFirstSubmitDate': '2014-04-22', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physicians satisfaction with teledermatology', 'timeFrame': '3 months', 'description': 'questionnaire at the end of the study using simple rating scales ranging from "Not satisfied" (1) to "very satisfied" (4)'}, {'measure': 'Number of non usable photographs in teledermatology group', 'timeFrame': '3 months', 'description': 'Number of non usable photographs in teledermatology group. Assessment by dermatologists who received the photograph. Reasons for non usability'}], 'primaryOutcomes': [{'measure': 'Delay before expertise by a dermatologist', 'timeFrame': '3 months', 'description': "Delay, in days, between a patient's consultation with his general practitioner and expertise by a dermatologist (teledermatology or classic consultation) that allows either diagnostic and/or initiation of treatment.\n\nFor example: in the teledermatology group, if the specialist needs to see the patient because the photographs cannot be analyzed correctly, date of expertise is the date of the consultation with the dermatologist.\n\nData is censured after 3 months."}], 'secondaryOutcomes': [{'measure': "Patient's satisfaction", 'timeFrame': '1 month after expertise by dermatologist', 'description': 'An investigator will call patients by telephone and assess their satisfaction with their care for the dermatologic condition using a simple rating scale with 4 items ranging from "Not satisfied" (1) to "very satisfied" (4).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['teledermatology', 'dermatology', 'general practice', 'organization of care'], 'conditions': ['Dermatologic Conditions']}, 'referencesModule': {'references': [{'pmid': '27496852', 'type': 'DERIVED', 'citation': 'Piette E, Nougairede M, Vuong V, Crickx B, Tran VT. Impact of a store-and-forward teledermatology intervention versus usual care on delay before beginning treatment: A pragmatic cluster-randomized trial in ambulatory care. J Telemed Telecare. 2017 Sep;23(8):725-732. doi: 10.1177/1357633X16663328. Epub 2016 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'In France, there is usually a long delay (approximately 6 weeks) before a general practitioner can obtain a specialized advice by dermatologists for diagnosis of "unusual" dermatologic conditions of their patients.\n\nPrevious studies have shown that teledermatology is a reliable way for diagnosis in dermatology.\n\nWe hypothesize that a teledermatology advice could reduce delay before diagnosis and therefore treatment for patients.', 'detailedDescription': 'In France, there is usually a long delay (approximately 6 weeks) before a general practitioner can obtain a specialized advice by dermatologists for diagnosis of "unusual" dermatologic conditions of their patients.\n\nPrevious studies have shown that teledermatology is a reliable way for diagnosis in dermatology.\n\nWe hypothesize that a teledermatology advice could reduce delay before diagnosis and therefore treatment for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consultation with a general practitioner for any motive during which, the general practitioner deems necessary to obtain a dermatologic expertise for a skin lesion (for diagnosis or treatment)\n\nExclusion Criteria:\n\n* Emergency, assessed by the general practitioner (needs care or quick telephonic advice in the next 24 hours)\n* Patients for which diagnosis and/or treatment are known by the general practitioner (the GP needs a dermatologic advice for a specific treatment (for example= laser, instrumental treatment...))\n* Patient cannot go the dermatologic consultation by himself (for example: dependant patients...)\n* Cognitive or psychiatric impairment (cannot give informed consent)'}, 'identificationModule': {'nctId': 'NCT02122432', 'acronym': 'TELEDERMATO', 'briefTitle': 'Teledermatology Versus Usual Care on Delay Before Diagnosis and Treatment of Dermatologic Conditions', 'organization': {'class': 'OTHER', 'fullName': 'University Paris 7 - Denis Diderot'}, 'officialTitle': 'Impact of Teledermatology Versus Usual Care on Delay Before Diagnosis and/or Treatment of Dermatologic Conditions in General Practice', 'orgStudyIdInfo': {'id': 'DMG002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teledermatology', 'description': 'General practitioner takes 3 photographs per dermatologic lesion using either a telephone with a 3Mega Pixel minimum camera or a standard camera following recommendations of the practice guidelines for teledermatology (2007) of the American Telemedicine Association and sends them to the dermatologist using a secured email server.\n\nDermatologist answer is standardized.', 'interventionNames': ['Other: Teledermatology']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care for dermatologic conditions requiring an expertise from a dermatologist involves the general practitioner 1) giving the patient a paper letter containing at least the following information: date of symptoms, symptomatology, topography of lesions, description of lesions, extension, recent drug intakes) and 2) telling him to see the dermatologist of his choice (patient manages his appointments alone).'}], 'interventions': [{'name': 'Teledermatology', 'type': 'OTHER', 'description': 'General practitioner takes 3 photographs per dermatologic lesion using either a telephone with a 3Mega Pixel minimum camera or a standard camera following recommendations of the practice guidelines for teledermatology (2007) of the American Telemedicine Association.\n\nPhotographs are sent by email using a secured mail server with at least the following information=date of symptoms, symptomatology, topography of lesions, description of lesions, extension, recent drug intakes)\n\nPhotographs are read and analyzed by a single dermatologist who gives an expert answer (diagnosis and/or treatment). Answer is sent back to the general practitioner by email (using a secured mail server). Answer contains at least the following information= are photographs usable? What is the diagnosis? If necessary, which treatment should the general practitioner begin ? If necessary, does the patient need a consultation with a dermatologist ?', 'armGroupLabels': ['Teledermatology']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'University paris Diderot', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Viet Thi Tran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University paris Diderot'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Paris 7 - Denis Diderot', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'TRAN Viet thi', 'investigatorAffiliation': 'University Paris 7 - Denis Diderot'}}}}