Atrial Fibrillation Health Literacy and Information Technology Trial in Pittsburgh, PA

Study Overview
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Brief Summary
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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 adherence to long-term (possibly lifelong) anticoagulation. The increased risks of stroke, heart failure and mortality associated with AF persist even with optimal treatment. Morbidity in AF is further exacerbated by social factors. Limited health literacy carries challenges of learning a specialized terminology and navigating specialized treatments. In multiple cardiovascular diseases, self-care has demonstrated improvement in self-efficacy, health-related quality of life, symptom burden, and health care utilization - essential components of patient success with AF. Selfcare can provide the critical skills to navigate a challenging chronic disease and improve patient-centered outcomes. Delivery of self-care as a mobile health intervention can complement standard care with a longitudinal intervention to improve patient-centered strategies for AF. While self-care interventions for AF have focused foremost on self-monitoring of anticoagulation,self-care has demonstrated its potential to meet the triple aim of improved patient experience, reduced health care utilization, and lower costs.

Detailed Description
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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 AHA 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.

Official Title
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A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care

Conditions
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Atrial Fibrillation, Familial Atrial Fibrillation, Arrythmia, Cardiac, Heart Diseases, Pathologic Processes

Intervention / Treatment
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* Behavioral: Relational Agent and heart rate and rhythm monitor
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, age ≥21; Diagnosis of AF, identified from the 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); CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke/TIA, CD, female sex)≥2; Prescribed use of warfarin or DOAC (formerly NOAC) 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 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. | Behavioral: Relational Agent and heart rate and rhythm monitor<br>* Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.<br>|
| Active Comparator: Usual care arm<br>Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. | Behavioral: Usual Care<br>* Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Days Covered | Proportion of Days Covered (PDC) is obtained from electronic prescription and pharmacy fill data for oral anticoagulation. PDC is calculated as a percentage (0 to 100%) accounting for days of prescription and date of fill. PDC quantification accounts for days of hospitalization, switching to an alternative anticoagulant agent, and prescribing changes during 12-month follow-up. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported adherence | A three-item instrument to ascertain self-reported non-adherence. Items are scored with a Likert scale from 0 (None fo the time.) to 5 (Every time.). The score is scaled as a continuous measure (0 to 15) and dichotomous categorization. | Baseline, 4, 8 and 12 months | 
| Change from baseline Atrial Fibrillation Effect on QualiTy of life (AFEQT) at 4, 8 and 12 months | The AFEQT is a widely used measure of atrial fibrillation-specific health-related quality of life. Scores range from 0 to 100 with higher scores indicating superior health-related quality of life in AF. The AFEQT measure consists of a global score and 4 domains (symptoms, daily activities, treatment concerns, and treatment satisfaction). We prioritize the global score because of its specificity to AF, our experience with this measure in our preliminary and pilot studies, extensive validation, and ease of administration. The AFEQT subdomains (symptoms, daily activities, treatment concerns, and treatment satisfaction) constitute secondary outcomes. | Baseline, 4, 8 and 12 months | 
| Emergency room visits | The number of emergency room visits will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms. | 4, 8 and 12 months | 
| Urgent care visits | The number of urgent care visits will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms. | 4, 8 and 12 months | 
| Days of hospitalization | The number of days of hospitalization will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms. | 4, 8 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life (QoL), Adherence, Health Literacy