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

Completed

• Conditions: Health Literacy; Atrial Fibrillation

• Registration Number: NCT03061123
• Lead Sponsor: Medical University of Graz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-23
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of subjective stroke risk perception with CHA2DS2-VASc score	Baseline
Comparison of subjective bleeding risk perception with HAS-BLED score	Baseline

Secondary Outcome Measures

Name	Time	Method
Relationship between accurate perception of stroke and bleeding risks and baseline parameters (highest completed level of education, subjective level of information)	Baseline

Trial Locations

Locations (8)

LKH Feldbach; 🇦🇹 Feldbach, Austria

LKH Fürstenfeld; 🇦🇹 Furstenfeld, Austria

Hospital Barmherzige Brueder Eggenberg; 🇦🇹 Graz, Austria

Hospital Elisabethinen; 🇦🇹 Graz, Austria

Medical University of Graz; 🇦🇹 Graz, Austria

Hospital Barmherzige Brueder Marschallgasse; 🇦🇹 Graz, Austria

LKH Hartberg; 🇦🇹 Hartberg, Austria

Ordination Dr. Zweiker; 🇦🇹 Straden, Austria