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

• Sponsor: Medical University of Graz (Other)
• Overall Status: Completed
• CT.gov ID: NCT03061123
• Collaborator: (none)
• Enrollment: 91
• Locations: 8
• Duration (Months): 25
• Patients Per Site: 11.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Health Literacy	Other: Questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 91 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular Atrial Fibrillation
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Outcome Measures

Primary Outcome Measures

1. Comparison of subjective stroke risk perception with CHA2DS2-VASc score [Baseline]

2. Comparison of subjective bleeding risk perception with HAS-BLED score [Baseline]

Secondary Outcome Measures

1. Relationship between accurate perception of stroke and bleeding risks and baseline parameters (highest completed level of education, subjective level of information) [Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LKH Feldbach	Feldbach		Austria	8330
2	LKH Fürstenfeld	Furstenfeld		Austria	8280
3	Hospital Barmherzige Brueder Eggenberg	Graz		Austria	8020
4	Hospital Barmherzige Brueder Marschallgasse	Graz		Austria	8020
5	Hospital Elisabethinen	Graz		Austria	8020
6	Medical University of Graz	Graz		Austria	8036
7	LKH Hartberg	Hartberg		Austria	8230
8	Ordination Dr. Zweiker	Straden		Austria	8345

Sponsors and Collaborators

• Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT03061123
• Other Study ID Numbers: 28-004 ex 15/16
• First Posted: Feb 23, 2017
• Last Update Posted: Nov 17, 2017
• Last Verified: Nov 1, 2017

• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Nov 17, 2017