Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2025-12-28 @ 7:29 AM
Study NCT ID:
NCT04815161
Status:
UNKNOWN
Last Update Posted:
2022-05-24
First Post:
2021-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2021-03-10', 'studyFirstSubmitQcDate': '2021-03-21', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of adherence', 'timeFrame': '2 years', 'description': 'The rate of adherence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Persistence rate', 'timeFrame': '2 years', 'description': 'Rate of persistence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed'}, {'measure': 'Rates of risk factors', 'timeFrame': '2 years', 'description': 'Risk factors for non-adherence and non-persistence in these patients will be evaluated'}, {'measure': 'Rates of different patient experiences', 'timeFrame': '2 years', 'description': 'Patient experiences with the Pilloxa box and application will be evaluated using questionnaires and quality intervjues'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adherence, Patient', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The ASTORIA study is a prospective cohort single-armed multicenter observational study that aims to assess adherence to rivaroxaban using a high technological electronical pillbox connected to a phone application in a group of atrial fibrillation patients with indication of long term anticoagulation treatment in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male patient with age \\> 18 years\n* Patients with atrial fibrillation\n* Patients initiated, continued on or switched to rivaroxaban for the indication atrial fibrillation with intended lifelong treatment (CHA2 DS2-VASc score ≥ 1).\n* The patient must agree to the use of the electronic medication adherence monitoring device, the so-called Pilloxa box and need to have a sufficient understanding of the app and functionality in conjunction with the use of the Pilloxa box.\n* Signed informed consent\n* No participation in an investigational program with interventions outside of routine clinical practice\n* No contra-indications according to the local marketing authorization\n\nExclusion Criteria:\n\n* Participation in an investigational program with interventions outside of routine clinical practice\n* Contra-indications according to the local marketing authorization'}, 'identificationModule': {'nctId': 'NCT04815161', 'acronym': 'ASTORIA', 'briefTitle': 'ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study', 'orgStudyIdInfo': {'id': '171965'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pilloxa pillbox', 'description': 'Patients receiving the Pilloxa pillbox for drug administration', 'interventionNames': ['Behavioral: Adherence']}], 'interventions': [{'name': 'Adherence', 'type': 'BEHAVIORAL', 'description': 'Adherence to medication using an electronic pillbox', 'armGroupLabels': ['Pilloxa pillbox']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dan Atar, MD, PhD', 'role': 'CONTACT', 'email': 'dan.atar@medisin.uio.no', 'phone': '+47 22119100'}, {'name': 'Marita Knudsen Pope, MD', 'role': 'CONTACT', 'email': 'marita.knudsen.pope@gmail.com', 'phone': '+47 92482991'}], 'overallOfficials': [{'name': 'Dan Atar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univerity of Oslo, Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not plan to share IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pilloxa', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dan Atar', 'investigatorAffiliation': 'Oslo University Hospital'}}}}