Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-28 @ 7:34 AM
Study NCT ID:
NCT03093558
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2017-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Atrial Fibrillation Information Technology Trial
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': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2017-03-02', 'studyFirstSubmitQcDate': '2017-03-22', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily adherence to the Embodied Conversational Agent and Kardia heart rhythm monitor', 'timeFrame': '30 days', 'description': 'Assessment of daily use of the combined ECA and Kardia heart rate/rhythm monitor'}], 'secondaryOutcomes': [{'measure': 'Participant experience of and response to using the ECA', 'timeFrame': '30 days', 'description': 'Open- and close-ended questions regarding participant experience of the ECA and response to its use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adherence', 'quality of life', 'health literacy'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '29473644', 'type': 'RESULT', 'citation': 'Magnani JW, Schlusser CL, Kimani E, Rollman BL, Paasche-Orlow MK, Bickmore TW. The Atrial Fibrillation Health Literacy Information Technology System: Pilot Assessment. JMIR Cardio. 2017 Jul-Dec;1(2):e7. doi: 10.2196/cardio.8543. Epub 2017 Dec 12.'}, {'pmid': '32886070', 'type': 'RESULT', 'citation': 'Guhl E, Althouse AD, Pusateri AM, Kimani E, Paasche-Orlow MK, Bickmore TW, Magnani JW. The Atrial Fibrillation Health Literacy Information Technology Trial: Pilot Trial of a Mobile Health App for Atrial Fibrillation. JMIR Cardio. 2020 Sep 4;4(1):e17162. doi: 10.2196/17162.'}, {'pmid': '28923492', 'type': 'DERIVED', 'citation': 'Guhl EN, Schlusser CL, Henault LE, Bickmore TW, Kimani E, Paasche-Orlow MK, Magnani JW. Rationale and design of the Atrial Fibrillation health Literacy Information Technology Trial: (AF-LITT). Contemp Clin Trials. 2017 Nov;62:153-158. doi: 10.1016/j.cct.2017.09.005. Epub 2017 Sep 18.'}]}, 'descriptionModule': {'briefSummary': "AF is associated with significant social and medical costs, including diminished quality of life (QOL) and increased health care utilization (HCU). This pilot study will enroll 200 adults with prevalent, non-valvular AF of ≤3 year's duration at University of Pittsburgh Medical Center (UPMC). The primary objective at present is to obtain extensive feasibility and pilot data in implementing the Embodied Conversational Agent (ECA) in concert with the Kardia (KAC) heart rhythm monitor.", 'detailedDescription': 'This pilot study is a single-center, two-arm randomized study that by design is unblinded. 200 total participants are planned. Each participant will be randomized in an unblocked manner to receive "usual care" or the ECA/KAC intervention. Participants will have study visits at baseline and time 30 days. Adherence to using the ECA/KAC in combination over 30 days will be quantified. Following participation study participants randomized to the ECA/KAC intervention will undergo an interview to determine their experience with the ECA/KAC. Participants and their physicians will receive a summary of ECA use and symptoms and correlated findings by KAC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CHADS2-VASc score ≥2; English-speaking (at level appropriate to provide informed consent and participate in this research protocol); no plan to relocate from the area within 12 months of enrollment\n\nExclusion Criteria:\n\n* AF that is due to non-cardiac causes (e.g., sepsis, pneumonia, thyroid disorders, and intoxication); AF within 30 days of any cardiothoracic or thoracic surgery; Inability to complete training session with the smartphone and demonstrate use of the ECA; Inability to answer specific protocol-based questions correctly during consent.'}, 'identificationModule': {'nctId': 'NCT03093558', 'briefTitle': 'Pilot Atrial Fibrillation Information Technology Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Pilot Atrial Fibrillation Information Technology Trial', 'orgStudyIdInfo': {'id': 'PRO16020290'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Receive the ECA/Kardia for 30-day use.', 'interventionNames': ['Behavioral: ECA/Kardia']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care arm', 'description': 'Receive a journal for observation of adherence and symptoms.'}], 'interventions': [{'name': 'ECA/Kardia', 'type': 'BEHAVIORAL', 'description': 'Use of the ECA and Kardia daily for 30 days.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'As this is a pilot study, IPD available by direct request to the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Jared W Magnani, MD, MSc', 'investigatorAffiliation': 'University of Pittsburgh'}}}}