NCT04299269

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

2.7 years

First QC Date

February 28, 2020

Last Update Submit

April 4, 2022

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

QuestionnaireOTHER

Questionnaire including questions about Quality of life, symptoms and general informations

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current atrial fibrillation/flutter
  • \>18 years of age
  • sufficient knowledge of the german language to fill out the questionnaire

You may not qualify if:

  • \< 18 years of age
  • insufficient knowledge of the german language to fill out the questionnaire
  • Hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKH Wien

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Nikola Schütz, Dr.med.univ.

CONTACT

004314040019640nikola.schuetz@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 6, 2020

Study Start

February 28, 2020

Primary Completion

November 1, 2022

Study Completion

February 1, 2023

Last Updated

April 6, 2022

Record last verified: 2022-04

Locations

AU(1)