ASsessment of Adherence TO Medication in AtRIAl Fibrillat... | NCT04815161

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

NCT04815161

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

May 24, 2022Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Adherence, Patient
Atrial Fibrillation

Interventions

Adherence

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2022Estimated

Primary Completion Date

Jun 2023Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Mar 10, 2021

First Submission Date that Met QC Criteria

Mar 21, 2021

First Posted Date

Mar 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2022

Last Update Posted Date

May 24, 2022Actual

Name	Class
Pilloxa	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pilloxa pillbox	Other	Patients receiving the Pilloxa pillbox for drug administration	Behavioral: Adherence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adherence	Behavioral	Adherence to medication using an electronic pillbox	Pilloxa pillbox

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Persistence rate	Rate of persistence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed	2 years
Rates of risk factors	Risk factors for non-adherence and non-persistence in these patients will be evaluated

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dan Atar, MD, PhD	Contact	+47 22119100		dan.atar@medisin.uio.no
Marita Knudsen Pope, MD	Contact	+47 92482991		marita.knudsen.pope@gmail.com

Overall Officials

Name	Affiliation	Role
Dan Atar, MD, PhD	Univerity of Oslo, Oslo University Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

We do not plan to share IPD.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010349	Patient Compliance
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided