Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT02455102
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Warning System for Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1707}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2015-05-22', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of initiation of adequate measures to prevent stroke (oral anticoagulant prescription) by physician in charge', 'timeFrame': 'End of hospital stay (expected average duration of 1 week)', 'description': 'Reviewed from discharge letter'}], 'secondaryOutcomes': [{'measure': 'Use of the CHA2DS2VASc score calculation tool by the physician in charge', 'timeFrame': 'During hospital stay (expected average duration of 1 week)'}, {'measure': 'Rate of correct evaluation of the CHA2DS2VASC Score through the calculation tool by physician in charge', 'timeFrame': 'End of hospital stay (expected average duration of 1 week)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prevention', 'Anticoagulation', 'Electronic warning system'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '27451467', 'type': 'DERIVED', 'citation': 'Silbernagel G, Spirk D, Hager A, Baumgartner I, Kucher N. Electronic Alert System for Improving Stroke Prevention Among Hospitalized Oral-Anticoagulation-Naive Patients With Atrial Fibrillation: A Randomized Trial. J Am Heart Assoc. 2016 Jul 22;5(7):e003776. doi: 10.1161/JAHA.116.003776.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled study is to evaluate whether a newly designed electronic warning system will increase the initiation rate of adequate stroke preventive measures in patients with atrial fibrillation.', 'detailedDescription': 'A large proportion of patients with atrial fibrillation do not receive stroke prevention therapy in line with the guidelines, in spite of the presence of an increased risk of stroke. It will be investigated whether an electronic alert to physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will increase the rate of adequate stroke preventive measures as compared to a control group of patients without an electronic alert. The electronic alerts will be sent if patients with atrial fibrillation but without adequate stroke preventive measures receive in-patient treatment at the University Hospital Bern. The electronic alert system includes a feature that helps the physicians in charge to evaluate the CHA2DS2VASC Score. At the end of the hospital stay medical discharge letters will be reviewed for initiation of adequate stroke preventive measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All in-patients with atrial fibrillation\n\nExclusion Criteria:\n\n* Ongoing anticoagulant therapy'}, 'identificationModule': {'nctId': 'NCT02455102', 'briefTitle': 'Electronic Warning System for Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Electronic Warning System to Improve Stroke Prevention in Atrial Fibrillation - A Quality Improvement Initiative at the University Hospital Bern', 'orgStudyIdInfo': {'id': '022/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Electronic alert', 'description': 'Physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will receive an electronic warning alert.', 'interventionNames': ['Other: Electronic warning alert']}, {'type': 'NO_INTERVENTION', 'label': 'No electronic alert', 'description': 'Physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will receive no electronic warning alert.'}], 'interventions': [{'name': 'Electronic warning alert', 'type': 'OTHER', 'description': 'A newly-installed warning system for stroke prevention in atrial fibrillation.', 'armGroupLabels': ['Electronic alert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3012', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'Swiss Cardiovascular Center, Inselspital, University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Nils Kucher, Prof. M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Angiology, Swiss Cardiovascular Center, University of Berne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}