ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study
ASTORIA
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedMay 24, 2022
May 1, 2022
1 year
March 10, 2021
May 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Persistence rate
2 years
Rates of risk factors
2 years
Rates of different patient experiences
2 years
Study Arms (1)
Pilloxa pillbox
OTHERPatients receiving the Pilloxa pillbox for drug administration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participation in an investigational program with interventions outside of routine clinical practice
- Contra-indications according to the local marketing authorization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Pilloxacollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Atar, MD, PhD
Univerity of Oslo, Oslo University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 10, 2021
First Posted
March 24, 2021
Study Start
June 1, 2022
Primary Completion
June 1, 2023
Study Completion
August 1, 2023
Last Updated
May 24, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
We do not plan to share IPD.