Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-03 @ 2:19 PM
Study NCT ID:
NCT02904018
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study of Oral Teleconsultation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019114', 'term': 'Remote Consultation'}], 'ancestors': [{'id': 'D012017', 'term': 'Referral and Consultation'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic of caries', 'timeFrame': '1 day', 'description': 'Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon'}], 'secondaryOutcomes': [{'measure': 'Diagnostic of caries', 'timeFrame': '6 months', 'description': 'Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dental Care']}, 'descriptionModule': {'briefSummary': 'In this study we want to evaluate the oral care pathway after an oral teleconsultation.', 'detailedDescription': "An oral teleconsultation was proposed to the 461 residents of the public hospital of Uzès. A specifically trained nurse recorded 4 videos (1 per quadrant) per mouth with an intra-oral camera using fluorescent light (Soprocare®) and keyed in information about the resident (general state, identification,…). These data were recorded and sent onto a central secured server, through a specific piece of software (e-DENT®). The dentists from the University Hospital of Montpellier were then able to analyse the videos remotely, make a diagnosis and organise each resident's oral care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People who are in long-term care home with oral telemedicine activity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject is aged at least 18 years\n* Patients cared for in their host institution\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT02904018', 'acronym': 'EDENT2', 'briefTitle': 'Validation Study of Oral Teleconsultation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Validation Study of Oral Teleconsultation - Study EDENT2', 'orgStudyIdInfo': {'id': '9370'}}, 'armsInterventionsModule': {'interventions': [{'name': 'teleconsultation', 'type': 'OTHER', 'description': 'Patients performing oral care required as a result of their diagnosis by teleconsultation in vulnerable populations (elderly, disabled adults).'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}