Atrial Fibrillation Health Literacy and Information Technology Trial

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 patients who reside in Pittsburgh-area with this condition and will randomize them to the intervention or control. Intervention participants will receive a smartphone with the agent, which simulates conversation. In addition they will receive an AliveCor Kardia for heart rate and rhythm monitoring, an FDA-approved, widely used instrument that pairs with the smartphone. Control participants will receive a smartphone with WebMD, a brochure published by the American Heart Association that describes AF, and an AliveCor Kardia. The intervention will last 4 months and participants will have visits at baseline, 4, 8 and 12 months. The study will evaluate the improvement in quality of life, medical adherence and health care utilization resulting from the intervention.

Inclusion criteria

• 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 criteria

• 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.