Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT06706635
Status:
RECRUITING
Last Update Posted:
2024-11-26
First Post:
2024-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective information level (EORTC QOL-INFO 25 questionnaire)', 'timeFrame': 'From enrollment to the end of FU at 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aortic stenosis', 'mobile app'], 'conditions': ['Aortic Stenosis Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to evaluate if an enhanced information by using a mobile App can increase subjective information level in patients with severe aortic stenosis and may therefore improve patient-reported outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe aortic valve stenosis\n* planned aortic valve replacement (TAVI)\n* Patient is willing and able to complete the surveys in German language\n* Written informed consent by the trial subject\n\nExclusion Criteria:\n\n\\- Language barrier'}, 'identificationModule': {'nctId': 'NCT06706635', 'acronym': 'TAVI-SDM-APP', 'briefTitle': 'Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Heart and Diabetes Center North-Rhine Westfalia'}, 'officialTitle': 'Impact of Enhanced Information Provision by Using a Mobile App on Subjective Information Level As the Basis for Shared-decision Making and Patient-reported Outcome Measures (PROMs) in Patients with Aortic Stenosis', 'orgStudyIdInfo': {'id': 'HDZ-KA_023_TR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full access to a mobile App', 'description': 'Study patients will receive full access to a mobile App', 'interventionNames': ['Device: Application of App']}, {'type': 'OTHER', 'label': 'Restricted access to a mobile App', 'description': 'Study patients will receive restricted access to a mobile App', 'interventionNames': ['Device: Application of App']}], 'interventions': [{'name': 'Application of App', 'type': 'DEVICE', 'description': 'Full Access to Mobile App', 'armGroupLabels': ['Full access to a mobile App', 'Restricted access to a mobile App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32545', 'city': 'Bad Oeynhausen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Astrid Kleemeyer', 'role': 'CONTACT', 'email': 'akleemeyer@hdz-nrw.de', 'phone': '+49 5731 971258'}, {'name': 'Tanja K. Rudolph, MD', 'role': 'CONTACT'}, {'name': 'Sara Waezsada, MD', 'role': 'CONTACT'}], 'facility': 'Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}], 'centralContacts': [{'name': 'Astrid Kleemeyer', 'role': 'CONTACT', 'email': 'akleemeyer@hdz-nrw.de', 'phone': '49 5731 971258'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart and Diabetes Center North-Rhine Westfalia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}