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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
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adherence, Patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 10, 2021
    Last Updated
    May 23, 2022
    Sponsor
    Oslo University Hospital
    Collaborators
    Pilloxa
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    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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