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

September 14, 2023 updated by: Medical University of Graz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldbach, Austria, 8330
        • LKH Feldbach
      • Furstenfeld, Austria, 8280
        • LKH Fürstenfeld
      • Graz, Austria, 8036
        • Medical University of Graz
      • Graz, Austria, 8020
        • Hospital Barmherzige Brueder Eggenberg
      • Graz, Austria, 8020
        • Hospital Barmherzige Brueder Marschallgasse
      • Graz, Austria, 8020
        • Hospital Elisabethinen
      • Hartberg, Austria, 8230
        • LKH Hartberg
      • Straden, Austria, 8345
        • Ordination Dr. Zweiker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with atrial fibrillation with new indication for anticoagulation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of subjective stroke risk perception with CHA2DS2-VASc score
Time Frame: Baseline
Baseline
Comparison of subjective bleeding risk perception with HAS-BLED score
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Relationship between accurate perception of stroke and bleeding risks and baseline parameters (highest completed level of education, subjective level of information)
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

February 17, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28-004 ex 15/16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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