ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study

Study Overview
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Brief Summary
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The ASTORIA study is a prospective cohort single-armed multicenter observational study that aims to assess adherence to rivaroxaban using a high technological electronical pillbox connected to a phone application in a group of atrial fibrillation patients with indication of long term anticoagulation treatment in routine clinical practice.

Official Title
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ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study

Conditions
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Adherence, Patient, Atrial Fibrillation

Intervention / Treatment
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* Behavioral: Adherence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male patient with age > 18 years Patients with atrial fibrillation Patients initiated, continued on or switched to rivaroxaban for the indication atrial fibrillation with intended lifelong treatment (CHA2 DS2-VASc score ≥ 1). The patient must agree to the use of the electronic medication adherence monitoring device, the so-called Pilloxa box and need to have a sufficient understanding of the app and functionality in conjunction with the use of the Pilloxa box. Signed informed consent No participation in an investigational program with interventions outside of routine clinical practice No contra-indications according to the local marketing authorization Exclusion Criteria: Participation in an investigational program with interventions outside of routine clinical practice Contra-indications according to the local marketing authorization

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pilloxa pillbox<br>Patients receiving the Pilloxa pillbox for drug administration | Behavioral: Adherence<br>* Adherence to medication using an electronic pillbox<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adherence | The rate of adherence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence rate | Rate of persistence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed | 2 years | 
| Rates of risk factors | Risk factors for non-adherence and non-persistence in these patients will be evaluated | 2 years | 
| Rates of different patient experiences | Patient experiences with the Pilloxa box and application will be evaluated using questionnaires and quality intervjues | 2 years |