Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-02-25 @ 4:39 PM
Study NCT ID:
NCT02309905
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2014-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Tele-expertise for Inmates With a Dermatological Lesion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-14', 'studyFirstSubmitDate': '2014-11-27', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of a dermatological expertise among those required', 'timeFrame': '1 month after the end of the study'}], 'secondaryOutcomes': [{'measure': 'Number of hospitalizations for a dermatological reason', 'timeFrame': '1 month after the end of the study'}, {'measure': 'Overall costs', 'timeFrame': '6 months after the end of the study'}, {'measure': 'Time to a dermatological expertise', 'timeFrame': '1 month after the end of the study'}, {'measure': 'Number of usual consultations needed after Tele-expertise', 'timeFrame': '1 month after the end of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inmates', 'skin lesion', 'telemedicine'], 'conditions': ['Skin Disease']}, 'referencesModule': {'references': [{'pmid': '22617736', 'type': 'BACKGROUND', 'citation': 'Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.'}, {'pmid': '30248151', 'type': 'DERIVED', 'citation': 'Zarca K, Charrier N, Mahe E, Guibal F, Carton B, Moreau F, Durand-Zaleski I. Tele-expertise for diagnosis of skin lesions is cost-effective in a prison setting: A retrospective cohort study of 450 patients. PLoS One. 2018 Sep 24;13(9):e0204545. doi: 10.1371/journal.pone.0204545. eCollection 2018.'}, {'pmid': '26857558', 'type': 'DERIVED', 'citation': 'Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.'}], 'seeAlsoLinks': [{'url': 'http://www.renewinghealth.eu/assessment-method', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Tele-expertise would be effective and cost-effective by reducing the number of secure transportations for inmates in need of a dermatological consultation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inmates', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dermatological expertise required\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02309905', 'acronym': 'TLM-Inmates', 'briefTitle': 'Evaluation of Tele-expertise for Inmates With a Dermatological Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of Tele-expertise for Inmates With a Dermatological Lesion', 'orgStudyIdInfo': {'id': 'Teledermatology for Inmates'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group before telemedicine', 'description': 'Inmates of prisons not having telemedicine before implementation of telemedicine in prisons having telemedicine'}, {'label': 'Control group after telemedicine', 'description': 'Inmates of prisons not having telemedicine after implementation of telemedicine in prisons having telemedicine'}, {'label': 'Exposed group, before telemedicine', 'description': 'Inmates of prisons having telemedicine before implementation of telemedicine'}, {'label': 'Exposed group, after telemedicine', 'description': 'Inmates of prisons having telemedicine after implementation of telemedicine', 'interventionNames': ['Device: Telemedicine']}], 'interventions': [{'name': 'Telemedicine', 'type': 'DEVICE', 'description': 'Inmates of prisons having telemedicine after implementation of telemedicine', 'armGroupLabels': ['Exposed group, after telemedicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95524', 'city': 'Cergy-Pontoise', 'country': 'France', 'facility': 'UCSA Osny', 'geoPoint': {'lat': 49.03894, 'lon': 2.07805}}, {'zip': '77351', 'city': 'Meaux', 'country': 'France', 'facility': 'UCSA Meaux', 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}, {'zip': '92014', 'city': 'Nanterre', 'country': 'France', 'facility': 'UCSA Nanterre', 'geoPoint': {'lat': 48.89198, 'lon': 2.20675}}, {'zip': '77550', 'city': 'Réau', 'country': 'France', 'facility': 'UCSA Réau', 'geoPoint': {'lat': 48.61022, 'lon': 2.62399}}, {'zip': '93420', 'city': 'Villepinte', 'country': 'France', 'facility': 'UCSA Villepinte', 'geoPoint': {'lat': 48.96203, 'lon': 2.53253}}], 'overallOfficials': [{'name': 'François Moreau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Versailles Hospital'}, {'name': 'Isabelle Durand-Zaleski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DRCD URC Eco. Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Agence Regionale de Sante d'Ile de France", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}