Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular AF

Atrial Fibrillation Clinical Trial

Official title:

Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03061123
• Other study ID #: 28-004 ex 15/16
• Status: Completed
• Start date: September 2015
• Est. completion date: October 2017

Study information

• Verified date: September 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Diagnosed and ECG-documented non-valvular atrial fibrillation
• New indication for oral anticoagulation (OAC)
• Ability of informed consent

Exclusion Criteria:

• Existing OAC therapy
• Valvular heart disease
• History of valve surgery

Related Conditions & MeSH terms

• Atrial Fibrillation
• Health Literacy

Intervention

Other:
• Questionnaire

Locations

Country	Name	City	State
Austria	LKH Feldbach	Feldbach
Austria	LKH Fürstenfeld	Furstenfeld
Austria	Hospital Barmherzige Brueder Eggenberg	Graz
Austria	Hospital Barmherzige Brueder Marschallgasse	Graz
Austria	Hospital Elisabethinen	Graz
Austria	Medical University of Graz	Graz
Austria	LKH Hartberg	Hartberg
Austria	Ordination Dr. Zweiker	Straden

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of subjective stroke risk perception with CHA2DS2-VASc score		Baseline
Primary	Comparison of subjective bleeding risk perception with HAS-BLED score		Baseline
Secondary	Relationship between accurate perception of stroke and bleeding risks and baseline parameters (highest completed level of education, subjective level of information)		Baseline