Survey on Belgian Patients Suffering From Irregular Heartbeat and Starting Treatment With a Drug to Prevent Blood Clots in Blood Vessels and the Heart. This Study is Also Called BELANCOS.

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Questionnaires

• Registration Number: NCT04183270
• Lead Sponsor: Bayer

Brief Summary

In this study researchers want to learn more about the patient's and treating doctor's concerns about possible bleedings during treatment with drugs preventing blood clots in blood vessels and the heart - so called blood thinner. The study also wants to find out more about the patient's knowledge on the importance, risks and benefits of treatment with this drug group.

Patients with irregular heartbeat not caused by valvular heart disease who will start treatment with a blood thinner will be asked by their treating cardiologist to complete a questionnaire related to their knowledge and fear of possible bleedings or stroke (blockage or rupture of a blood vessel to the brain) due to the intake of a blood thinner. The treating doctor will complete a similar questionnaire. The study plans to involve 15 cardiologists and 300 patients in Belgium.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-03
• Study Start: 2020-02-10
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Questionnaires	Non-valvular atrial fibrillation (NVAF) patients who will start treatment with a non-VKA oral anticoagulants (NOAC).
Physicians	Questionnaires	Treating physicians for NVAF patients.

Primary Outcome Measures

Name	Time	Method
Age categories of patients	1 day	Collected via the questionnaire.
Level of patients fear of having a stroke or thrombosis assessed by physicians on a scale from 0 - 10	1 day
Level of patients fear of having a stroke or thrombosis on a scale from 0 - 10	1 day
Patients' level of agreement with various statements of using NOACs in general	1 day	By using a 5-point Likert scale (completely disagree, more likely to disagree, no opinion, more likely to agree, completely agree)
Level of patients fear of having a bleeding on a scale from 0 - 10	1 day
Level of patients fear of having a bleeding assessed by physicans on a scale from 0 - 10	1 day
Gender (Female or male) of patients	1 day	Collected via the questionnaire.
Age categories of physicians	1 day	Collected via the questionnaire.
Gender (Female or male) of physicians	1 day	Collected via the questionnaire.
Physicans' level of agreement with various statement of using NOACs in general	1 day	By using a 5-point Likert scale (completely disagree, more likely to disagree, no opinion, more likely to agree, completely agree)

Trial Locations

Locations (1)

Many locations; 🇧🇪 Multiple Locations, Belgium