Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT06322004
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2023-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Video-Interpreting in Prehospital Emergency Medicine - Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Feasibility', 'timeFrame': 'Immediately after use of video-interpreting', 'description': 'The technical feasibility endpoint evaluates the possibility of video-interpreting.\n\nThe occurrence of technical problems will be reported.'}, {'measure': 'Usability of video-interpreting', 'timeFrame': 'Immediately after use of video-interpreting', 'description': 'The usability will be evaluated after the rescue mission by the prehospital emergency doctor using a questionnaire including following items on a 7-point Likert scale (strongly disagree to strongly agree):\n\n* Video-translation was easy to use.\n* I feel comfortable to use video-translation during the situation.\n* The amount of time involved to use video-translation has been fitting for me.\n* I would use video-translation again.\n* Video-translation was useful for my healthcare practice in this situation.'}, {'measure': "Impact on emergency physician's decisions", 'timeFrame': 'Immediately after use of video-interpreting', 'description': 'The impact of video-translation will be evaluated regarding alteration of medical history, treatment or target hospital.'}], 'secondaryOutcomes': [{'measure': 'Demographic parameters', 'timeFrame': 'Immediately after use of video-interpreting', 'description': 'Following characteristics of the patients will be recorded:\n\nAge, Gender, primary diagnosis of the prehospital emergency physician'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Communication barriers', 'Prehospital emergency medicine', 'Emergency medicine', 'Emergency physician'], 'conditions': ['Communication Barriers']}, 'descriptionModule': {'briefSummary': '50 responsive patients with language barriers will be included in this study. The prehospital emergency physician will start video-interpreting via a tablet. Feasibility, quality of communication, usability as well as changes in diagnosis and treatment will be gathered and analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 responsive patients treated by prehospital emergency doctors of the Department of Anaesthesia, Intensive Care and Pain Management (Medical University of Vienna/ General Hospital of Vienna) with language barrier (14 languages Albanian, Dari, Romanian, Turkish, Modern Standard Arabic, Arabic, Farsi, Russian, Hungarian, Bosnian-Croatian-Serbian, Kurdish (Kurmanci), Slovakian, Bulgarian, Polish, and Czech) will be included regarding inclusion and exclusion criteria mentioned above.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, at least 18 years old\n* awake, responsive patients\n* language barrier (Albanian, Dari, Romanian, Turkish, Modern Standard Arabic, Arabic, Farsi, Russian, Hungarian, Bosnian-Croatian-Serbian, Kurdish (Kurmanci), Slovakian, Bulgarian, Polish, and Czech)\n\nExclusion Criteria:\n\n* unconscious patients\n* out-of-hospital cardiac arrest patients\n* delay of treatment or transportation due to e-interpreting\n* refusal of video-interpreting by the patient'}, 'identificationModule': {'nctId': 'NCT06322004', 'briefTitle': 'Video-Interpreting in Prehospital Emergency Medicine - Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Video-Interpreting in Prehospital Emergency Medicine - Feasibility Study', 'orgStudyIdInfo': {'id': '1718/2022'}}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christina Hafner, DDr.', 'role': 'CONTACT', 'email': 'christina.hafner@meduniwien.ac.at'}, {'name': 'Maike Fink, Dr.med.univ.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christina Hafner, DDr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Maike Fink, Dr.med.univ.', 'role': 'CONTACT', 'email': 'maike.fink@meduniwien.ac.at', 'phone': '01/40400 41000'}, {'name': 'Christina Hafner', 'role': 'CONTACT', 'email': 'christina.hafner@meduniwien.ac.at'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christina Hafner', 'investigatorAffiliation': 'Medical University of Vienna'}}}}