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

NCT ID: NCT04815161

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-08-31

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.

Detailed Description

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Conditions

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Adherence, Patient Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pilloxa pillbox

Patients receiving the Pilloxa pillbox for drug administration

Group Type OTHER

Adherence

Intervention Type BEHAVIORAL

Adherence to medication using an electronic pillbox

Interventions

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Adherence

Adherence to medication using an electronic pillbox

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pilloxa

INDUSTRY

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dan Atar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Atar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Univerity of Oslo, Oslo University Hospital

Central Contacts

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Dan Atar, MD, PhD

Role: CONTACT

+47 22119100

Marita Knudsen Pope, MD

Role: CONTACT

+47 92482991

Other Identifiers

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171965

Identifier Type: -

Identifier Source: org_study_id

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