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.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients Non-valvular atrial fibrillation (NVAF) patients who will start treatment with a non-VKA oral anticoagulants (NOAC). |
Other: Questionnaires
The survey will focus on non-valvular atrial fibrillation patients, who will start treatment with a NOAC, and their treating physician.
|
| Physicians Treating physicians for NVAF patients. |
Other: Questionnaires
The survey will focus on non-valvular atrial fibrillation patients, who will start treatment with a NOAC, and their treating physician.
|
Outcome Measures
Primary Outcome Measures
- Age categories of patients [1 day]
Collected via the questionnaire.
- Gender (Female or male) of patients [1 day]
Collected via the questionnaire.
- 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 stroke or thrombosis on a scale from 0 - 10 [1 day]
- 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)
- Level of patients fear of having a bleeding assessed by physicans on a scale from 0 - 10 [1 day]
- Level of patients fear of having a stroke or thrombosis assessed by physicians on a scale from 0 - 10 [1 day]
Eligibility Criteria
Criteria
Inclusion criteria:
-
Male or female adult patients diagnosed with NVAF.
-
NOAC treatment-naive patients who will start a NOAC treatment.
Exclusion criteria:
-
Previous stroke or thrombosis
-
Previous severe bleeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many locations | Multiple Locations | Belgium |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21153