Atrial FibrillationNCT04299269
"Info-AF" Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms
A study testing Questionnaire in people with Atrial Fibrillation, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this project is to identify a variable that discerns patients who are interested in their disease (atrial fibrillation/atrial flutter) from patients who show no interest and furthermore test this theory in a questionnaire survey. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Questionnaire
- How many people
- 130 participants
- Where
- 1 siteAustria
- Study dates
- 28 Feb 2020to Feb 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current atrial fibrillation/flutter
- >18 years of age
- sufficient knowledge of the german language to fill out the questionnaire
Who cannot join
- < 18 years of age
- insufficient knowledge of the german language to fill out the questionnaire
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
AKH Wien
Vienna, 1090
Nikola Schütz, Dr.med.univ., 004314040019640, nikola.schuetz@meduniwien.ac.at
About this study
The aim of this project is to identify a variable that discerns patients who are interested in their disease (atrial fibrillation/atrial flutter) from patients who show no interest and furthermore test this theory in a questionnaire survey.
This should help distinguish between patients who are interested in shared decision making and patients who are not (further projects planned).
- Conditions
- Atrial Fibrillation
- 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
Questionnaire including questions about Quality of life, symptoms and general informations
What is being measured
The primary outcome is the main question the study is designed to answer.
Preferences for autonomy measured with questionnaire
Potential predictors of the outcome are clinical symptoms. Additional covariables will be patient characteristics including age and gender and disease characteristics. Regression analysis will be used as the main statistical method. Descriptive statistics and graphs and inferential statistics will be used as appropriate.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start28 Feb 2020
- Primary completionNov 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikola Schütz, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299269
- Sponsor's protocol ID
- 1617/2019
- Status last verified
- Apr 2022
- First submitted
- 28 Feb 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Info-AF" Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms
- ClinicalTrials.gov ID
- NCT04299269
- Acronym / sponsor ID
- 1617/2019
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 6 Mar 2020 (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 aim of this project is to identify a variable that discerns patients who are interested in their disease (atrial fibrillation/atrial flutter) from patients who show no interest and furthermore test this theory in a questionnaire survey.
This should help distinguish between patients who are interested in shared decision making and patients who are not (further projects planned).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current atrial fibrillation/flutter
- >18 years of age
- sufficient knowledge of the german language to fill out the questionnaire
Key exclusion criteria (3 listed)
- < 18 years of age
- insufficient knowledge of the german language to fill out the questionnaire
- Hemodynamic instability
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 |
|---|---|---|
| QuestionnaireQuestionnaire including questions about Quality of life, symptoms and general informations | Other | – |
Primary outcome
Preferences for autonomy measured with questionnaire
Time frame: through study completion, an average of 1 year
Potential predictors of the outcome are clinical symptoms. Additional covariables will be patient characteristics including age and gender and disease characteristics. Regression analysis will be used as the main statistical method. Descriptive statistics and graphs and inferential statistics will be used as appropriate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Atrial Fibrillation, run by Medical University of Vienna at 1 site 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikola Schütz, Dr.med.univ. (004314040019640, nikola.schuetz@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preferences for autonomy measured with questionnaire (time frame: through study completion, an average of 1 year). 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 6 Apr 2022.