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

Atrial Fibrillation Clinical Trial

— ASTORIA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04815161
• Other study ID #: 171965
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: August 2023

Study information

• Verified date: May 2022
• Source: Oslo University Hospital
• Contact: Dan Atar, MD, PhD
• Phone: +47 22119100
• Email: dan.atar[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient
• Atrial Fibrillation

Intervention

Behavioral:
• Adherence
Adherence to medication using an electronic pillbox

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Pilloxa

Outcome

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