Status:
COMPLETED
Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Northeastern University
Conditions:
Atrial Fibrillation
Familial Atrial Fibrillation
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Atrial fibrillation (AF) is a highly prevalent, morbid condition. Anticoagulation to prevent thromboembolic strokes is a foremost priority in AF but adherence is challenging for patients and lapses in...
Detailed Description
This is a randomized clinical trial to evaluate the effect of an embodied conversational agent (ECA) on health outcomes in people with atrial fibrillation. The study will enroll 264 patients who resid...
Eligibility Criteria
Inclusion
- Adult, age ≥21;
- Diagnosis of AF, identified from the electronic health record (EHR) problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (CG, Holter or event monitor);
- Prescribed use of warfarin or direct-acting oral anticoagulant (DOAC) for AF stroke prevention;
- English-speaking well enough to participate in informed consent and this study;
- No plans to relocate from the area within 12 months of enrollment.
Exclusion
- Conditions other than AF that require anticoagulation, such as mechanical prosthetic valve, deep vein thrombosis, or pulmonary embolism;
- History of pulmonary vein isolation or foreseen pulmonary vein isolation;
- History of atrioventricular (AV) nodal ablation or foreseen AV nodal ablation;
- Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
- Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion;
- Untreated hyperthyroidism or ≤3 months euthyroidism before inclusion;
- Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy;
- Cardiac surgery ≤3 months before inclusion;
- Planned cardiac surgery;
- Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
- Inability to comprehend the study protocol, defined as failing to answer correctly a set of questions on orientation and short-term memory during the consent process.
Key Trial Info
Start Date :
January 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2023
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04076020
Start Date
January 8 2020
End Date
August 2 2023
Last Update
May 30 2024
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213