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.

NCT04722679 | Completed

• 1 other identifier: 21740
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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

Non-Valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (14)

• Age categories of patients and the geriatricians

  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

• CHA₂DS₂-VASc range

  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.

  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

• Specification of HCP that initiated the elderly patient's NOAC treatment

  HCP: HealthCare Professionals

  Approximate 3 months for data collection

• 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

• 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

• 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

Study Arms (2)

Patient

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

Drug: Non-VKA Oral Anticoagulants (NOAC)

Physician

Geriatricians (hospital or office-based).

Drug: Non-VKA Oral Anticoagulants (NOAC)

Interventions

Non-VKA Oral Anticoagulants (NOAC) DRUG

Follow clinical practice.

Patient; Physician

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Belgium

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: May 11, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 3, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

BE (1)