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

Not Applicable

• Conditions: Adherence, Patient; Atrial Fibrillation
• Interventions: Behavioral: Adherence

• Registration Number: NCT04815161
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-21
• Study First Posted: 2021-03-24
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24
• Study Start: 2022-06
• Primary Completion: 2023-06
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilloxa pillbox	Adherence	Patients receiving the Pilloxa pillbox for drug administration

Primary Outcome Measures

Name	Time	Method
Rate of adherence	2 years	The rate of adherence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed.

Secondary Outcome Measures

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