## Protocol Section
### Identification Module
**NCT ID:** NCT04722679

**Acronym:** BELANCE

**Brief Title:** 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.

**Official Title:** BELgian ANtiCoagulation Survey for Elderly Patients With NVAF

#### Organization Study ID Info
**ID:** 21740
#### Organization
**Class:** INDUSTRY
**Full Name:** Bayer
### Status Module
#### Completion Date
**Date:** 2022-01-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-03-22

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2021-05-11

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2021-01-25
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-21
**Study First Submit QC Date:** 2021-01-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bayer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Non-Valvular Atrial Fibrillation

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 103

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Elderly (defined as the ≥75 years old) patients with NVAF that are treated with a NOAC.

**Intervention Names:**

- Drug: Non-VKA Oral Anticoagulants (NOAC)

**Label:** Patient

#### Arm Group 2

**Description:** Geriatricians (hospital or office-based).

**Intervention Names:**

- Drug: Non-VKA Oral Anticoagulants (NOAC)

**Label:** Physician

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patient

- Physician

**Description:** Follow clinical practice.

**Name:** Non-VKA Oral Anticoagulants (NOAC)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Age categories of patients and the geriatricians

**Time Frame:** Approximate 3 months for data collection

**Measure:** Gender of patients and the geriatricians

**Time Frame:** Approximate 3 months for data collection

**Measure:** Patient's weight

**Time Frame:** Approximate 3 months for data collection

**Measure:** Patient's kidney function range (normal, mild, moderate, severe)

**Time Frame:** Approximate 3 months for data collection

**Description:** 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.

**Measure:** CHA₂DS₂-VASc range

**Time Frame:** Approximate 3 months for data collection

**Measure:** Clinical Frailty Scale (CFS) range

**Time Frame:** Approximate 3 months for data collection

**Measure:** Timeframe of patient's diagnosis with NVAF

**Time Frame:** Approximate 3 months for data collection

**Description:** HCP: HealthCare Professionals

**Measure:** Specification of HCP that initiated the elderly patient's NOAC treatment

**Time Frame:** Approximate 3 months for data collection

**Measure:** Specification of NOAC treatment

**Time Frame:** Approximately 3 months for data collection

**Measure:** Use of low-dose NOAC treatment (not related to an (S)AE)

**Time Frame:** Approximate 3 months for data collection

**Measure:** Confirmation of the use of anti-aggregants

**Time Frame:** Approximate 3 months for data collection

**Measure:** 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)

**Time Frame:** Approximate 3 months for data collection

**Measure:** Indication of fear of contracting a bleeding while using a blood thinner on a scale from 0 - 10

**Time Frame:** Approximate 3 months for data collection

**Measure:** Indication of fear of contracting a stroke or thrombosis on a scale from 0 - 10

**Time Frame:** Approximate 3 months for data collection

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 75 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

**Study Population:** The source population of this study would be elderly patients population (defined as ≥ 75 years old) diagnosed with NVAF who are treated with a NOAC for this indication. In order to ensure the representativeness of the study population, 100-150 Belgian elderly patients will be taken into account.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Multiple Locations

**Country:** Belgium

**Facility:** Many Locations

### IPD Sharing Statement Module

**Description:** Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M22306

- Name: Stroke

- Relevance: LOW

- As Found: Unknown

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M16686

- Name: Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001281

- Term: Atrial Fibrillation

### Intervention Browse Module - Browse Branches

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4244

- Name: Anticoagulants

- Relevance: HIGH

- As Found: High Grade

### Intervention Browse Module - Meshes

- ID: D000000925

- Term: Anticoagulants

### Misc Info Module

- Version Holder: 2024-05-24
