Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-05 @ 6:19 PM
Study NCT ID:
NCT04788966
Status:
COMPLETED
Last Update Posted:
2021-03-09
First Post:
2021-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Innovative Speech-enabled Translator in Emergency Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction evaluation through a 4-point scale survey', 'timeFrame': 'During the consultation', 'description': "Are patients' and doctors' satisfied with the use of BabelDr?"}, {'measure': 'Efficacy evaluation through a 2-point scale survey', 'timeFrame': 'During the consultation', 'description': "Can BabelDr be efficient tool in an emergency context: are doctors' able to reach a diagnostic with the tool?"}, {'measure': 'Technical features evaluation through a 4-point scale survey', 'timeFrame': 'During the consultation', 'description': "Are the technical features appreciated by the doctors'?"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Translation tool', 'Anamnesis'], 'conditions': ['Diagnoses Disease']}, 'descriptionModule': {'briefSummary': 'Survey-based satisfaction, performance and technical features evaluation of a speech-enabled fixed-phrase translation tool (BabelDR) in an emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 patients were recruited with an average age of M=38.2 (SD=16.49) of which 53.33% were males. The distribution between the different languages was the following: Spanish (11), Arabic (4), Farsi (7), Tigrinya (7) and Albanian (1).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* As per inclusion criteria, patients were required to have no understanding of French, thus making a diagnostic interview by the doctors impossible.\n\nExclusion Criteria:\n\n* Exclusion criteria concerned patients who shared a common language with the doctor and/or were not able to read in their native language.'}, 'identificationModule': {'nctId': 'NCT04788966', 'briefTitle': 'Evaluation of an Innovative Speech-enabled Translator in Emergency Settings', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Evaluation of an Innovative Speech-enabled Translator in Emergency Settings', 'orgStudyIdInfo': {'id': 'Réq 2017-00996'}}, 'armsInterventionsModule': {'interventions': [{'name': 'the translation tool BabelDr', 'type': 'DEVICE', 'description': 'Doctors use a speech-enabled fixed-phrase translation tool to help communicate with an allophone patient.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University Hospitals of Geneva (HUG)', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Geneva, Switzerland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Antony Janakiram', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}