"Info-AF" Information Preferences in Patients With Atrial... | NCT04299269

Studies
"Info-AF" Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms

NCT04299269

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Apr 6, 2022Actual

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

Questionnaire

Countries

Austria

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2020Actual

Primary Completion Date

Nov 2022Estimated

Completion Date

Feb 2023Estimated

First Submitted Date

Feb 28, 2020

First Submission Date that Met QC Criteria

Mar 5, 2020

First Posted Date

Mar 6, 2020Actual

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

Apr 4, 2022

Last Update Posted Date

Apr 6, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nikola Schütz, Principal Investigator, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 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).

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

130Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Questionnaire including questions about Quality of life, symptoms and general informations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nikola Schütz, Dr.med.univ.	Contact	004314040019640		nikola.schuetz@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AKH Wien	Recruiting	Vienna		1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided