Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-03-01 @ 12:17 AM
Study NCT ID:
NCT03871569
Status:
TERMINATED
Last Update Posted:
2020-08-27
First Post:
2019-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014076', 'term': 'Tooth Diseases'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'whyStopped': 'Difficulty recruiting and follow-up due to the epidemic context of COVID19', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-03-11', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost-Utility ratio of buccodental telemedicine in nursing home as compared to usual care', 'timeFrame': 'At month 6', 'description': 'Costs include telemedicine and medical costs related to oral health care. Utility correspond to the Quality Adjusted Life-Years (QALY) score measured using the EQ5D-3L questionnaire (EuroQol 3 levels of 5 dimensions).'}], 'secondaryOutcomes': [{'measure': 'Cost/Efficacity ratio of buccodental telemedicine in nursing home as compared to usual care', 'timeFrame': 'At month 6', 'description': 'Costs include telemedicine and medical costs related to oral health care.\n\nThe clinical efficacy criteria correspond to the proportion of patients with a zero dental emergency score. The score of Emergency is measured according to WHO classification:\n\nScore "0" correspond to "unnecessary care"\n\nScore "1" correspond to "descaling required"\n\nScore "2" correspond to "Low urgency: need for restoration and/or crown but not immediately (superficial damage to the tooth). Includes patients requiring fixed and/or removable prostheses".\n\nScore "3" correspond to: "Advanced emergency: need for restorations and/or crowns quickly (within 7 to 14 days) to avoid pulp damage and/or infection"\n\nScore "4" correspond to: "High urgency: urgent need for care due to pain and/or infection. Includes patients requiring endodontic treatment or extraction"'}, {'measure': 'Quality of life comparison: EQ5D-3L questionnaire', 'timeFrame': 'At month 6', 'description': "The Quality of Life measured using the EQ5D-3L (EuroQol 3 levels of 5 dimensions) questionnaire. EQ-5D-3L questionnaire comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Levels of perceived problems are coded as follows: Level 1 (no problems) is coded as a '1' - Level 2 (some problems) is coded as a '2' - Level 3 (extreme problems) is coded as a '3'. The best score for the 5 dimensions is coded by '11111' and the worst state is coded by '33333'. In addition a EQ visual analogue scale (EQ VAS) help people say how good or bad a health state is, on which the best state is marked 100 and the worst state is marked 0."}, {'measure': 'Economic impact of teleexpertise on dental treatment', 'timeFrame': 'At month 6', 'description': 'Budgetary impact of the new coverage expressed in annual cash flows'}, {'measure': 'Evaluate satisfaction rate of use of teleexpertise of nursing home staff', 'timeFrame': 'At month 6', 'description': 'Satisfaction of nursing home staff measured by an ad hoc Likert scale'}, {'measure': 'Compare the emergency score', 'timeFrame': 'At month 0 and at month 6', 'description': 'The emergency score measured by the Oral Health Assessment Tool (OHAT) questionnaire. The OHAT comprises eight categories of screening tool to assess oral health : Lips, Tongue, Gums and tissues, Saliva, Natural teeth, Dentures, Oral cleanliness, Dental pain. After a dental examination by telemedicine, the dentist will evaluate each category as following : Score "0" correspond to "healthy", score "1" corresponds to "changes" or score "3" correspond to "unhealthy".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'dentistry', 'long-term-care-home'], 'conditions': ['Tooth Diseases']}, 'descriptionModule': {'briefSummary': 'Oral care in medical and social institutions is a real public health problem. The impact of poor oral health on the general state of residents but also on their overall quality of life is significant.\n\nThe development of a precise regulatory framework for telemedicine in France aims to transform experiments into sustainable medical activities. Odontology often set aside in this reflection, must be reintegrated. The use of tele-expertise for the oral care of nursing home residents should make it possible to replace oral health in medico-social institutions. The investigators will assess in a cluster randomized controlled study whether the buccodental telemedicine has a viable economic model and a significant impact on the overall health of facility for dependent elderly persons residents.\n\nThe medico-economic impact of the buccodental telexpertise is fundamental for the development of this innovative activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be resident of a facility for dependent elderly persons involved in the study\n* Have given their Free, informed and signed consent\n* Beneficiary or member of a social security scheme\n\nExclusion Criteria:\n\n* incapacity to open the mouth\n* contrary opinion of the medical team (end of life)\n* Change of nursing home planned within 6 months\n* Subject in a period of relative exclusion from another protocol\n* Subject's participation in another study\n* Subject deprived of liberty by judicial or administrative decision"}, 'identificationModule': {'nctId': 'NCT03871569', 'acronym': 'e-DENT-EHPAD', 'briefTitle': 'Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home', 'orgStudyIdInfo': {'id': 'RECHMPL18_0079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'telemedecine nursing home', 'description': 'One buccodental teleexpertise at the completion day and a second buccodental teleexpertise at the end of study', 'interventionNames': ['Other: bucco-dental teleexpertise']}, {'type': 'NO_INTERVENTION', 'label': 'control nursing home', 'description': 'Only one buccodental teleexpertise at the end of study'}], 'interventions': [{'name': 'bucco-dental teleexpertise', 'type': 'OTHER', 'description': 'A bucco-dental consultation remotely using telemedicine system', 'armGroupLabels': ['telemedecine nursing home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12370', 'city': 'Belmont-sur-Rance', 'country': 'France', 'facility': 'EHPAD Le Sherpa', 'geoPoint': {'lat': 43.81812, 'lon': 2.7543}}, {'zip': '34170', 'city': 'Castelnau-le-Lez', 'country': 'France', 'facility': 'EHPAD Via Domitia', 'geoPoint': {'lat': 43.63605, 'lon': 3.90137}}, {'zip': '34770', 'city': 'Gigean', 'country': 'France', 'facility': 'EHPAD Korian La Colombe', 'geoPoint': {'lat': 43.50028, 'lon': 3.71167}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'EHPAD Korian Perier', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34590', 'city': 'Marsillargues', 'country': 'France', 'facility': 'EHPAD La Roselière', 'geoPoint': {'lat': 43.66478, 'lon': 4.1767}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'EHPAD Françoise Gauffier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'EHPAD Korian La Pompignane', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'EHPAD La Carriera', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'EHPAD Montpellieret', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'EHPAD Pierre Laroque', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '66370', 'city': 'Pezilla La Rivière', 'country': 'France', 'facility': 'Résidence mutualiste de Pezilla'}, {'zip': '12460', 'city': 'Saint-Amans-des-Cots', 'country': 'France', 'facility': 'EHPAD Saint Jean', 'geoPoint': {'lat': 44.68931, 'lon': 2.65855}}, {'zip': '66490', 'city': 'St. Jean-Pla-de-Corts', 'country': 'France', 'facility': 'EHPAD Saint Jean Pla de Corts', 'geoPoint': {'lat': 42.51069, 'lon': 2.79091}}], 'overallOfficials': [{'name': 'Nicolas Giraudeau, DDS, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}