Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT06761105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Anonymous Data from a Digital Tool for Medical History-Taking to Improve Healthcare Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2033-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2025-01-04', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use patterns', 'timeFrame': 'From enrollment to the end of app use, up to 8 years', 'description': 'Evaluation of the use patterns and frequencies of the medical history tool'}], 'secondaryOutcomes': [{'measure': 'Data quality', 'timeFrame': 'From enrollment to the end of app use, up to 8 years', 'description': 'Investigation of the consistency and completeness of the medical history data collected by the medical history tool'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['digital medical history', 'anonymized usage data', 'general practice', 'GP consultations', 'GP', 'health services research'], 'conditions': ['Health Services Research']}, 'descriptionModule': {'briefSummary': "This study aims to understand how people use a mobile app that helps them record their symptoms before going to the doctor. Patients use the app on a tablet or other digital device. The app guides patients through a series of structured questions tailored to their symptoms. The data collected is then transferred to the practice's electronic record and is available to the treating doctor before and during the consultation.\n\nIn this project, anonymized usage data will be analyzed to contribute to the further development of the tool and to provide valuable insights for health services research.", 'detailedDescription': 'In several studies the usability of digital medical history tools has been demonstrated. These tools allow acute complaints to be recorded using an app before a medical consultation and the data collected to be transferred to the electronic medical record.\n\nThe aim of the study is to investigate the effectiveness and use of a digital medical history tool that is becoming increasingly popular in general practice. To this end, it is aimed to evaluate anonymized usage data provided by the company that distributes the app, aidminutes gUG, as part of an observational study with the aim of identifying potential for further development and for questions of health services research (e.g. on the frequency of GP consultations, morbidity and frequency of complaints). This is a retrospective data analysis of anonymous routine data in a cross-sectional design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lower Saxony, Germany', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients that use the app in a general practice that agreed to provide data\n* all ages (including children if the app is used by parent or legal guardian)\n* all complaints chosen in the app\n\nExclusion Criteria:\n\n* patients that use the app in a general practice that did not agree to provide data\n* patients that use the app in a general practice outside of the federal state Lower Saxony'}, 'identificationModule': {'nctId': 'NCT06761105', 'briefTitle': 'Using Anonymous Data from a Digital Tool for Medical History-Taking to Improve Healthcare Services', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Goettingen'}, 'officialTitle': 'Observation of the Use of Digital Tools for Medical History-Taking in Primary Care and Utilization of Anonymous Routine Data for Health Services Research', 'orgStudyIdInfo': {'id': '4/8/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients who have used the digital medical history tool in one of the participating general practices'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37073', 'city': 'Göttingen', 'state': 'Lower Saxony', 'country': 'Germany', 'contacts': [{'name': 'Frank Müller, MD PhD', 'role': 'CONTACT', 'email': 'frank.mueller@med.uni-goettingen.de', 'phone': '+495513965663'}], 'facility': 'Department of General Practice', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}], 'centralContacts': [{'name': 'Frank Müller, MD PhD', 'role': 'CONTACT', 'email': 'frank.mueller@med.uni-goettingen.de', 'phone': '+495513965663'}, {'name': 'Eva Maria Noack', 'role': 'CONTACT', 'email': 'evamaria.noack@med.uni-goettingen.de', 'phone': '+495513965745'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Needs to be discussed with responsible data officer'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Goettingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Frank Müller, MD, PhD, MSc', 'investigatorAffiliation': 'University Hospital Goettingen'}}}}