Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-22 @ 10:23 AM
Study NCT ID:
NCT03901495
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2019-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DD Assessment With Diaana #2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The first 50 eligible patients of the emergency outpatient unit in Geneva University Hospital are recruited into the control group (without access to "Diaana"). The next 50 eligible patients are recruited into the intervention group (with access to "Diaana").'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-07', 'studyFirstSubmitDate': '2019-03-02', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differential diagnosis established by the resident physician', 'timeFrame': 'At day 0', 'description': "The resident physician will select up to 5 diagnose in an exhaustive list. The senior physician will do the same in order to establish the gold-standard differential diagnosis.\n\nThe accuracy of the resident's differential diagnosis will be measured as the percentage of correct diagnose selected by the resident compared to the gold standard."}], 'secondaryOutcomes': [{'measure': 'Consultation time', 'timeFrame': 'At day 0', 'description': "The resident's consultation (with and without the patient) will be measured by the research coordinator. Consultation time will be compared between groups. A shorter consultation time will be considered as a better outcome."}, {'measure': 'Patient satisfaction', 'timeFrame': 'At day 0', 'description': "Into the experimental group, the patient's satisfaction will be evalued on a Lickert 1-4 scale. 1= fully dissatisfied; 2 = partially dissatisfied; 3 = partially satisfied; 4 = fully satisfied"}, {'measure': 'Differential diagnosis estabished by Diaana', 'timeFrame': 'At day 0', 'description': 'The Diaana system will select diagnoses in an exhaustive list. The senior physician will select up to 5 diagnose in an exhaustive list in order to establish the gold-standard differential diagnosis.\n\nThe accuracy of the differential diagnosis established by the Diaana system will be measured as the percentage of correct diagnose selected compared to the gold standard.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['differential diagnosis', 'hospital outpatient clinics', 'clinical applications software'], 'conditions': ['Decision Making', 'Computer-assisted', 'General Practitioners', 'Patient Engagement']}, 'referencesModule': {'references': [{'pmid': '40205939', 'type': 'DERIVED', 'citation': 'Healey B, Schwitzguebel A, Spechbach H. Differential Diagnosis Assessment in Ambulatory Care With a Digital Health History Device: Pseudorandomized Study. JMIR Form Res. 2025 Oct 1;9:e56384. doi: 10.2196/56384.'}]}, 'descriptionModule': {'briefSummary': 'Single-center, unblinded, 1:1 parallel pseudo-randomized efficacy trial.\n\nIn the intervention group only, resident physicians will be assisted by the automated medical history-taking device "Diaana" during their consultations in outpatient ambulatory unit of the Geneva University Hospital.\n\nIn both groups, the differential diagnosis of the resident physician will be compared to the gold-standard differential diagnosis of the senior physician.', 'detailedDescription': 'Automated medical history-taking devices (AMHTD) are emerging tools with the potential to increase the quality of medical consultations by providing physicians with an exhaustive, high-quality, standardized anamnesis and differential diagnosis. In this study, the investigators aimed to establish whether an AMHTD of interest, "Diaana", allowed the physician to establish a more precise differential diagnosis.\n\nA single-center, unblinded, 1:1 parallel pseudo-randomized efficacy trial will be performed. No follow-up is necessary, because patients are seen once and all data are collected on this time. The study will take place in the emergency outpatient unit of Geneva University Hospital and include patients suffering from symptoms covered by Diaana.\n\nPatients in the intervention group will fullfil Dianna. Then, the resident physician will read Diaana summary, perform his consultation, and fullfil case report form, including his differential diagnosis. Then, the senior physician will see the patient and establish the gold-standard differential diagnosis. In the control group, the residents will directely establish a differential diagnosis, without the help of Diaana.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting to the emergency outpatient unit of Geneva University Hospital\n* Patients suffering from symptoms localized to the superior or inferior member, the back, hand the chest wall.\n\nExclusion Criteria:\n\n* Strictly dermatologic concerns\n* Toes and inversion ankle trauma (because the diagnosis of those conditions is generally obvious)\n* Medical condition considered as urgent\n* Inability to complete de digilatized Diaana form (sight problems, language, inability to use a tablet computer)'}, 'identificationModule': {'nctId': 'NCT03901495', 'acronym': 'DiaanaRCT#2', 'briefTitle': 'DD Assessment With Diaana #2', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Differential Diagnosis Assessment in Ambulatory Care With an Automated Medical History-Taking Device: A Confirmatory Pseudo-Randomized Study', 'orgStudyIdInfo': {'id': 'UNIGE_Diaana'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diaana', 'description': '1. The patient fullfill Diaana\n2. The resident physician takes connaissance of the Diaana summary\n3. The resident physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)\n4. The senior physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)', 'interventionNames': ['Other: Diaana']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '1. The resident physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)\n2. The senior physician see the patient in consultation. He establishes his DD without having access to the complementay exams (blood tests, x-ray, ...)'}], 'interventions': [{'name': 'Diaana', 'type': 'OTHER', 'otherNames': ['Automated medical history-taking device (AMHTD)'], 'description': 'Diaana, the AMHTD used, functions as follows: on the basis of an interactive questionnaire completed by the patient before the consultation, it performs an exhaustive anamnesis focused on the problem and proposes a panel of DDs with a high sensitivity. The artificial reasoning system of "Diaana" mimics how a specialist physician would reason to establish a DD. The information transmitted is in an easy-to-use form for the physician that includes a summary of the anamnesis centered on relevant elements from the questionnaire and a list of possible diagnoses with their emergency level, potential contributing factors, and first-line management proposals.', 'armGroupLabels': ['Diaana']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospital', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Hervé Spechbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be avaliable within 3 months of the study completion', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcomes measures will be made avaliable', 'accessCriteria': 'Under request to the sponsor.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adrien Schwitzguebel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Independant physician', 'investigatorFullName': 'Adrien Schwitzguebel', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}