A Study to Collect Information on the Characteristics of Elderly Belgian Patients With NVAF That Are Treated With a NOAC for This Indication With a Special Focus on Their Fear of Bleeding While Using a NOAC vs the Clinical Benefit of a NOAC of Thrombosis/Stroke Prevention.

Completed

• Conditions: Non-Valvular Atrial Fibrillation
• Interventions: Drug: Non-VKA Oral Anticoagulants (NOAC)

• Registration Number: NCT04722679
• Lead Sponsor: Bayer

Brief Summary

Atrial fibrillation is a heart condition that causes an abnormal and fast heart rate. For people with non-valvular atrial fibrillation (NVAF), this is caused by problems such as high blood pressure and diabetes. NVAF happens more often in elderly people and can lead to stroke, heart failure, and death. Doctors are currently able to give patients a type of treatment called an anticoagulant. Anticoagulants work by making the blood thinner. They are thought to help reduce the risk of stroke and death caused by NVAF. In this study, researchers wanted to learn more about what elderly people think of taking anticoagulants that do not have any vitamin K in them. These are called non-VKA oral anticoagulants (NOACs).

This study will include up to about 150 Belgian men and women aged 75 years and over who have NVAF and have been treated with NOACs. The study will also include about 10 doctors who have treated these patients.

In this study, there will be no required tests or visits. Instead, patients will answer a paper questionnaire about their use of NOACs. The researchers will ask the doctors questions about how they treat their patients using NOACs. The main types of questions the researchers will focus on are:

* The patient characteristics of the elderly with NVAF who are treated with NOACs

* The level of fear of the elderly about bleeding while using a blood thinner and the fear of stroke/thrombosis.

* The geriatrician's thoughts about using NOACs to treat NVAF in elderly patients

* Those patient characteristics geriatrician's find most important when deciding on the anticoagulation treatment in the elderly patients.

The information from this study will be collected between February and April 2021. But, the whole study will take about 6 months to finish and is expected to end in July 2021.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-25
• Study Start: 2021-05-11
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Male or female elderly patients (defined as ≥ 75 years old) diagnosed with NVAF
• Elderly patients treated with a NOAC
• Ambulatory patients visiting the geriatrician

Exclusion Criteria

• Contra-indications according to the local marketing authorization
• Patients suffering from dementia who are, according to the geriatrician's opinion, not able to understand and answer the questions
• Hospitalized patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient	Non-VKA Oral Anticoagulants (NOAC)	Elderly (defined as the ≥75 years old) patients with NVAF that are treated with a NOAC.
Physician	Non-VKA Oral Anticoagulants (NOAC)	Geriatricians (hospital or office-based).

Primary Outcome Measures

Name	Time	Method
Specification of HCP that initiated the elderly patient's NOAC treatment	Approximate 3 months for data collection	HCP: HealthCare Professionals
Specification of NOAC treatment	Approximately 3 months for data collection
Use of low-dose NOAC treatment (not related to an (S)AE)	Approximate 3 months for data collection
Confirmation of the use of anti-aggregants	Approximate 3 months for data collection
CHA₂DS₂-VASc range	Approximate 3 months for data collection	CHA2DS2-VASc score is a clinical prediction rule for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke.
Level of agreement with various statements regarding the use of NOACs in general, using a 5-point Likert scale (completely disagree, more likely to disagree, no opinion, more likely to agree, completely agree)	Approximate 3 months for data collection
Clinical Frailty Scale (CFS) range	Approximate 3 months for data collection
Timeframe of patient's diagnosis with NVAF	Approximate 3 months for data collection
Gender of patients and the geriatricians	Approximate 3 months for data collection
Patient's weight	Approximate 3 months for data collection
Patient's kidney function range (normal, mild, moderate, severe)	Approximate 3 months for data collection
Indication of fear of contracting a bleeding while using a blood thinner on a scale from 0 - 10	Approximate 3 months for data collection
Indication of fear of contracting a stroke or thrombosis on a scale from 0 - 10	Approximate 3 months for data collection
Age categories of patients and the geriatricians	Approximate 3 months for data collection

Trial Locations

Locations (1)

Many Locations; 🇧🇪 Multiple Locations, Belgium