Adherence, PatientASTORIANCT04815161
ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study
A study testing Adherence in people with Adherence, Patient and Atrial Fibrillation, run by Oslo University Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence, Patient, Atrial Fibrillation
- What is being tested?
- Adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participation in an investigational program with interventions outside of routine clinical practice
- Contra-indications according to the local marketing authorization
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Adherence, Patient, Atrial Fibrillation
- Being tested
- Adherence
- Medical subject headings
- Patient Compliance, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdherenceBehavioural
Adherence to medication using an electronic pillbox
| Study group | Role | What they receive |
|---|---|---|
| Pilloxa pillbox | Other | Patients receiving the Pilloxa pillbox for drug administration Receives: Behavioral: Adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adherence
The rate of adherence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed.
Measured: 2 years
Secondary outcomes (3)
Persistence rate
Rate of persistence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed
Measured: 2 years
Rates of risk factors
Risk factors for non-adherence and non-persistence in these patients will be evaluated
Measured: 2 years
Rates of different patient experiences
Patient experiences with the Pilloxa box and application will be evaluated using questionnaires and quality intervjues
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study startJun 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, PatientStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pilloxa
- Responsible party
- Principal investigator, Dan Atar, Oslo University Hospital
- Investigators
- Dan Atar, MD, PhD, Principal investigator, Univerity of Oslo, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815161
- Sponsor's protocol ID
- 171965
- Acronym
- ASTORIA
- Status last verified
- May 2022
- First submitted
- 10 Mar 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASsessment of Adherence TO Medication in AtRIAl Fibrillation - an eMonitoring Drug Dispensing Device Study
- ClinicalTrials.gov ID
- NCT04815161
- Acronym / sponsor ID
- ASTORIA / 171965
- Conditions
- Adherence, Patient, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Pilloxa
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilloxa pillbox | Other | Behavioral: AdherencePatients receiving the Pilloxa pillbox for drug administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in an investigational program with interventions outside of routine clinical practice
- Contra-indications according to the local marketing authorization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdherenceAdherence to medication using an electronic pillbox | Behavioural | Pilloxa pillbox |
Primary outcome
Rate of adherence
Time frame: 2 years
The rate of adherence to rivaroxaban in a group of atrial fibrillation patients using the Pilloxa box will be assessed.
3 secondary outcomes
Persistence rate
Time frame: 2 years
Rates of risk factors
Time frame: 2 years
Rates of different patient experiences
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No. We do not plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Atar, MD, PhD principal investigator
Univerity of Oslo, Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Adherence in people with Adherence, Patient and Atrial Fibrillation, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Atar, MD, PhD (+47 22119100, dan.atar@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adherence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.