Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-31 @ 12:06 AM
Study NCT ID:
NCT05032495
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2021-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Engagement Study to Evaluate the Use of Biological Therapies for Cardiac Arrhythmias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D017144', 'term': 'Focus Groups'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2021-09-01', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants that would accept a biological therapy for a cardiac arrhythmia as assessed using a survey', 'timeFrame': '2 years', 'description': 'accept a biological therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient engagement'], 'conditions': ['Arrythmia']}, 'referencesModule': {'references': [{'pmid': '39026620', 'type': 'DERIVED', 'citation': 'Smith C, Lalu MM, Davis DR. Exploring Patient Viewpoints to Optimize Implementation of a Biological Therapy for Atrial Fibrillation Prevention. CJC Open. 2024 Apr 16;6(7):893-900. doi: 10.1016/j.cjco.2024.04.003. eCollection 2024 Jul.'}]}, 'descriptionModule': {'briefSummary': 'In this patient engagement study, patients and partners will attend a presentation, group meeting and responding to the survey to help the research team gage the acceptability of using a biological therapy to prevent cardiac arrhythmia. Patient Partners will also help to clarify which outcomes are important to patients, to ensure the selected outcomes align with patient interests.', 'detailedDescription': 'There will be four study groups:\n\n1. Heart patients who experienced a cardiac arrhythmia while in hospital,\n2. Heart patients who did not experience a cardiac arrhythmia while in hospital,\n3. Heart patients with an upcoming procedure that have not had a cardiac arrhythmia,\n4. Members of the general public.\n\nThere will be a presentation, two surveys and a team meeting. Results will be compiled and analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from in house databases after confirming patients have agreed to participate in research.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Upcoming or previous cardiac procedure.\n\nExclusion Criteria:\n\n* Inability to complete an electronic survey or participate in a small group meeting.'}, 'identificationModule': {'nctId': 'NCT05032495', 'briefTitle': 'Patient Engagement Study to Evaluate the Use of Biological Therapies for Cardiac Arrhythmias', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Patient Directed Strategies for Cardiac Arrhythmia', 'orgStudyIdInfo': {'id': '3174'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart patients who experienced a cardiac arrhythmia while in hospital', 'description': 'Heart patients who experienced a cardiac arrhythmia while in hospital', 'interventionNames': ['Other: Surveys', 'Other: Focus group']}, {'label': 'Heart patients who did not experience a cardiac arrhythmia while in hospital', 'description': 'Heart patients who did not experience a cardiac arrhythmia while in hospital', 'interventionNames': ['Other: Surveys', 'Other: Focus group']}, {'label': 'Heart patients with an upcoming procedure that have not had a cardiac arrhythmia', 'description': 'Heart patients with an upcoming procedure that have not had a cardiac arrhythmia', 'interventionNames': ['Other: Surveys', 'Other: Focus group']}, {'label': 'Members of the general public', 'description': 'Members of the general public', 'interventionNames': ['Other: Surveys', 'Other: Focus group']}], 'interventions': [{'name': 'Surveys', 'type': 'OTHER', 'description': 'Surveys to evaluate prior experience, opinions and intervention acceptability.', 'armGroupLabels': ['Heart patients who did not experience a cardiac arrhythmia while in hospital', 'Heart patients who experienced a cardiac arrhythmia while in hospital', 'Heart patients with an upcoming procedure that have not had a cardiac arrhythmia', 'Members of the general public']}, {'name': 'Focus group', 'type': 'OTHER', 'description': 'To answer any questions and discuss topics covered in the standard presentation.', 'armGroupLabels': ['Heart patients who did not experience a cardiac arrhythmia while in hospital', 'Heart patients who experienced a cardiac arrhythmia while in hospital', 'Heart patients with an upcoming procedure that have not had a cardiac arrhythmia', 'Members of the general public']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Insitute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Darryl Davis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Darryl Davis', 'investigatorAffiliation': 'Ottawa Heart Institute Research Corporation'}}}}