Atrial FibrillationNCT03061123
Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular AF
An observational study of Atrial Fibrillation and Health Literacy, run by Medical University of Graz at 8 sites in Austria.
Trial summary
The risk of stroke is markedly elevated in patients with atrial fibrillation (AF). Oral anticoagulation (OAC) is indicated in individuals with moderate and high risk of stroke to the disadvantage of an increased burden from bleeding. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Health Literacy
- What is being tested?
- Questionnaire
- How many people
- 91 participants
- Where
- 8 sitesAustria
- Study dates
- Sep 2015to Oct 2017
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation with new indication for anticoagulation.
Who may be able to join
- Diagnosed and ECG-documented non-valvular atrial fibrillation
- New indication for oral anticoagulation (OAC)
- Ability of informed consent
Who cannot join
- Existing OAC therapy
- Valvular heart disease
- History of valve surgery
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Austria8 sites
LKH Feldbach
Feldbach, 8330
LKH Fürstenfeld
Fürstenfeld, 8280
Hospital Barmherzige Brueder Eggenberg
Graz, 8020
Hospital Barmherzige Brueder Marschallgasse
Graz, 8020
Hospital Elisabethinen
Graz, 8020
Medical University of Graz
Graz, 8036
LKH Hartberg
Hartberg, 8230
Ordination Dr. Zweiker
Straden, 8345
About this study
Official title: Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular Atrial Fibrillation
The risk of stroke is markedly elevated in patients with atrial fibrillation (AF). Oral anticoagulation (OAC) is indicated in individuals with moderate and high risk of stroke to the disadvantage of an increased burden from bleeding. Adequate knowledge of this disorder and understanding the benefits and hazards of antithrombotic treatment are essential to incorporate patient´s values and preferences in these decisions. This will further improve acceptance of recommended therapy and augment compliance with OAC.
The objective of this investigation is to compare patient´s perceptions and physician´s assessments of benefits and risks of OAC.
- Conditions
- Atrial Fibrillation, Health Literacy
- Being tested
- Questionnaire
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of subjective stroke risk perception with CHA2DS2-VASc score
Measured: Baseline
Comparison of subjective bleeding risk perception with HAS-BLED score
Measured: Baseline
Secondary outcomes (1)
Relationship between accurate perception of stroke and bleeding risks and baseline parameters (highest completed level of education, subjective level of information)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startSep 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061123
- Sponsor's protocol ID
- 28-004 ex 15/16
- Status last verified
- Sep 2023
- First submitted
- 17 Feb 2017
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Zweiker D, Zweiker R, Winkler E, Roesch K, Schumacher M, Stepan V, Krippl P, Bauer N, Heine M, Reicht G, Zweiker G, Sprenger M, Watzinger N. Association between subjective risk perception and objective risk estimation in patients with atrial fibrillation: a cross-sectional study. BMJ Open. 2017 Sep 25;7(9):e018242. doi: 10.1136/bmjopen-2017-018242.
PubMed 28951417
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03061123
- Acronym / sponsor ID
- 28-004 ex 15/16
- Conditions
- Atrial Fibrillation, Health Literacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 23 Feb 2017 (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 risk of stroke is markedly elevated in patients with atrial fibrillation (AF). Oral anticoagulation (OAC) is indicated in individuals with moderate and high risk of stroke to the disadvantage of an increased burden from bleeding. Adequate knowledge of this disorder and understanding the benefits and hazards of antithrombotic treatment are essential to incorporate patient´s values and preferences in these decisions. This will further improve acceptance of recommended therapy and augment compliance with OAC.
The objective of this investigation is to compare patient´s perceptions and physician´s assessments of benefits and risks of OAC.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation with new indication for anticoagulation.
Key inclusion criteria (3 listed)
- Diagnosed and ECG-documented non-valvular atrial fibrillation
- New indication for oral anticoagulation (OAC)
- Ability of informed consent
Key exclusion criteria (3 listed)
- Existing OAC therapy
- Valvular heart disease
- History of valve surgery
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 |
|---|---|---|
| Questionnaire | Other | – |
Primary outcome
Comparison of subjective stroke risk perception with CHA2DS2-VASc score
Time frame: Baseline
Comparison of subjective bleeding risk perception with HAS-BLED score
Time frame: Baseline
1 secondary outcome
Relationship between accurate perception of stroke and bleeding risks and baseline parameters (highest completed level of education, subjective level of information)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Derived from this study: PubMed 28951417Zweiker D, Zweiker R, Winkler E, Roesch K, Schumacher M, Stepan V, Krippl P, Bauer N, Heine M, Reicht G, Zweiker G, Sprenger M, Watzinger N. Association between subjective risk perception and objective risk estimation in patients with atrial fibrillation: a cross-sectional study. BMJ Open. 2017 Sep 25;7(9):e018242. doi: 10.1136/bmjopen-2017-018242.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Health Literacy, run by Medical University of Graz at 8 sites in Austria.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of subjective stroke risk perception with CHA2DS2-VASc score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061123, which also lists 1 linked publication.
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 15 Sep 2023.