ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study (ASTORIA)
Primary Purpose
Adherence, Patient, Atrial Fibrillation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adherence
Sponsored by
About this trial
This is an interventional other trial for Adherence, Patient
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pilloxa pillbox
Arm Description
Patients receiving the Pilloxa pillbox for drug administration
Outcomes
Primary Outcome Measures
Rate of adherence
The rate of adherence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed.
Secondary Outcome Measures
Persistence rate
Rate of persistence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed
Rates of risk factors
Risk factors for non-adherence and non-persistence in these patients will be evaluated
Rates of different patient experiences
Patient experiences with the Pilloxa box and application will be evaluated using questionnaires and quality intervjues
Full Information
NCT ID
NCT04815161
First Posted
March 10, 2021
Last Updated
May 23, 2022
Sponsor
Oslo University Hospital
Collaborators
Pilloxa
1. Study Identification
Unique Protocol Identification Number
NCT04815161
Brief Title
ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study
Acronym
ASTORIA
Official Title
ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Pilloxa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adherence, Patient, Atrial Fibrillation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilloxa pillbox
Arm Type
Other
Arm Description
Patients receiving the Pilloxa pillbox for drug administration
Intervention Type
Behavioral
Intervention Name(s)
Adherence
Intervention Description
Adherence to medication using an electronic pillbox
Primary Outcome Measure Information:
Title
Rate of adherence
Description
The rate of adherence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Persistence rate
Description
Rate of persistence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed
Time Frame
2 years
Title
Rates of risk factors
Description
Risk factors for non-adherence and non-persistence in these patients will be evaluated
Time Frame
2 years
Title
Rates of different patient experiences
Description
Patient experiences with the Pilloxa box and application will be evaluated using questionnaires and quality intervjues
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Atar, MD, PhD
Phone
+47 22119100
Email
dan.atar@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Marita Knudsen Pope, MD
Phone
+47 92482991
Email
marita.knudsen.pope@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Atar, MD, PhD
Organizational Affiliation
Univerity of Oslo, Oslo University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share IPD.
Learn more about this trial
ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study
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