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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04815161
Acronym
ASTORIA
Enrollment
200
Registered
2021-03-24
Start date
2022-06-30
Completion date
2023-08-31
Last updated
2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence, Patient, Atrial Fibrillation

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.

Interventions

BEHAVIORALAdherence

Adherence to medication using an electronic pillbox

Sponsors

Pilloxa
CollaboratorINDUSTRY
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of adherence2 yearsThe rate of adherence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed.

Secondary

MeasureTime frameDescription
Persistence rate2 yearsRate of persistence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed
Rates of risk factors2 yearsRisk factors for non-adherence and non-persistence in these patients will be evaluated
Rates of different patient experiences2 yearsPatient experiences with the Pilloxa box and application will be evaluated using questionnaires and quality intervjues

Contacts

Primary ContactDan Atar, MD, PhD
dan.atar@medisin.uio.no+47 22119100
Backup ContactMarita Knudsen Pope, MD
marita.knudsen.pope@gmail.com+47 92482991

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026