Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm

Study Overview
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Brief Summary
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There is a need to determine actual compliance of direct oral anticoagulants and how to improve this to reduce risk of stroke in patients with atrial fibrillation. Mobile health tools have been implemented world-wide in various patient populations as means of reducing cardiovascular risk and improving disease management. Results of these interventions have been mixed with some interventions demonstrating significant improvement while others demonstrated no difference between the intervention group and the control group. More importantly, these studies indicate that implementation of mobile health tools is feasible in various patient populations and it may just be a matter of finding the correct intervention for a given disease state. The aim of this study is to increase awareness of atrial fibrillation as a means of improving compliance with anticoagulant medication.

Detailed Description
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The primary hypothesis of this study is that patients with atrial fibrillation will have improved compliance with apixaban therapy if they complete a daily measurement of heart rhythm via a smartphone electrocardiogram monitor, as compared to patients managed in a conventional manner. Primary Endpoint Primary Endpoint 1: is the percent compliance with apixaban therapy as measured by the amount of apixaban medication that was consumed per month. Compliance is defined as the extent to which a patient acts in accordance with the prescribed interval and dose of a dosing regimen. Percent compliance will be measured as a continuous variable and strict cutoffs for 'compliant' and 'non-compliant' status will not be imposed. Secondary Endpoints Secondary Endpoint 1: is the number of deaths from any cause, stroke, and hospitalization for atrial fibrillation and/or congestive heart failure. Given the low numbers of patients in this study, this will be a composite endpoint of all of these outcomes, since there is insufficient sample size to examine each outcome individually. Secondary Endpoint 2: is the self assessment of atrial fibrillation symptom severity through the use of a standardized scale. While the secondary endpoints are not directly related to the primary endpoint, there is a possibility that the intervention may lead to changes in health maintenance behavior, which may lead to differences in the secondary endpoints. While this study may not be powered to differentiate between these secondary endpoints, if a trend is noted, this may be hypothesis generating for future studies.

Official Title
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Better Outcomes for Anticoagulation Treatment Through Observation of Atrial Rhythm (BOAT OAR)

Conditions
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Non-valvular Atrial Fibrillation

Intervention / Treatment
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* Device: Alive Cor Kardia mobile electrocardiogram monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-valvular atrial fibrillation that is either paroxysmal, persistent or permanent CHA2DS2VASc score of 2 or more Eligible for therapy with apixaban for at least 6 months Possession of a smartphone capable of pairing with the AliveCor Kardia cardiac monitor Exclusion Criteria: Contraindication to anticoagulation with apixaban for at least 6 months No access to a smartphone capable of pairing with the AliveCor Kardia cardiac monitor Unable to provide informed consent for this protocol

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, prospective
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>In the experimental group, each patient will be issued an AliveCor Kardia electrocardiogram monitor that is compatible with their smartphone. Patients will be instructed on the use of the monitor at the initial visit with the study nurse. The patient will submit daily electrocardiogram transmission via on online portal. The study nurse may contact them via text message to remind them to submit their recordings, if they forget. The remainder of the treatment of the experimental group will be identical to the control group. At the conclusion of the study, the patient will complete their final atrial fibrillation symptom assessment scale. Their smartphone electrocardiogram monitor will be reviewed to ensure that all of the recordings were retrieved successfully. | Device: Alive Cor Kardia mobile electrocardiogram monitor<br>* Mobile ECG monitor paired with smart phone application<br>|
| No Intervention: Control<br>Patients in the control group would receive the standard of care treatment for atrial fibrillation, including cardioversion and ablation as indicated. At monthly visits with the study nurse, a smartphone electrocardiogram monitor will be used to record patient's heart rhythm. No other intervention would be performed during the monthly visit. It is necessary to meet the subject at least once per month to receive the previous month's supply of pills and provide them with the next month's supply of pills. If these subjects were met less frequently, it is possible that the previous month's supply of pills might be lost by the end of the study. During the study, if the patient is taken off anticoagulation due to medical contraindication or after an ablation, they will continue to be followed monthly but will not receive apixaban medication. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anticoagulation compliance | percent compliance with apixaban therapy | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of deaths, strokes, and hospitalizations | number of deaths from any cause, stroke, and hospitalization for atrial fibrillation and/or congestive heart failure | 12 months | 
| AF symptom severity | self assessment of atrial fibrillation symptom severity through the use of a the Atrial Fibrillation Effect on QualiTy of Life (AFEQT) Questionnaire. Section 1 of the scale gathers details about whether or not the patient is symptomatic and how often they are having symptoms. Section 2 is evaluated as a score from 14-98 indicating the total effect of atrial fibrillation on quality of life. Lower values represent a better outcome. Subscales are not combined. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apixaban, atrial fibrillation