Status:
COMPLETED
Atrial Fibrillation Health Literacy and Information Technology Trial
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 common, morbid condition with increasing prevalence. Poor health-related quality of life is common in AF. Patients experience debilitating symptoms and challenging adhere...
Detailed Description
This is a randomized clinical trial to evaluate the effect of a smartphone-based intervention called a relational agent on health outcomes in people with atrial fibrillation. The study will enroll 240...
Eligibility Criteria
Inclusion
- Adult, age ≥21;
- Diagnosis of AF, identified from the electronic health record problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (electrocardiogram, Holter or event monitor);
- CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke or transient ischemic attack, coronary heart disease, female sex)≥2;
- Prescribed use of warfarin or direct-acting oral anticoagulant 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 nodal ablation or foreseen atrioventricular 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 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT04075994
Start Date
January 2 2020
End Date
August 1 2023
Last Update
May 30 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213