Back to results"Info-AF" Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Current atrial fibrillation/flutter
- >18 years of age
- sufficient knowledge of the german language to fill out the questionnaire
Exclusion Criteria:
- < 18 years of age
- insufficient knowledge of the german language to fill out the questionnaire
- Hemodynamic instability
Sites / Locations
- AKH WienRecruiting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04299269
First Posted
February 28, 2020
Last Updated
April 4, 2022
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04299269
Brief Title
"Info-AF" Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms
Official Title
"Info-AF" Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
This should help distinguish between patients who are interested in shared decision making and patients who are not (further projects planned).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
130 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Questionnaire including questions about Quality of life, symptoms and general informations
Primary Outcome Measure Information:
Title
Preferences for autonomy measured with questionnaire
Description
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.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current atrial fibrillation/flutter
>18 years of age
sufficient knowledge of the german language to fill out the questionnaire
Exclusion Criteria:
< 18 years of age
insufficient knowledge of the german language to fill out the questionnaire
Hemodynamic instability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikola Schütz, Dr.med.univ.
Phone
004314040019640
Email
nikola.schuetz@meduniwien.ac.at
Facility Information:
Facility Name
AKH Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikola Schütz, Dr.med.univ.
Phone
004314040019640
Email
nikola.schuetz@meduniwien.ac.at
12. IPD Sharing Statement
Learn more about this trial
"Info-AF" Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms
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