Atrial Fibrillation
Conditions
Brief summary
The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.
Detailed description
Purpose:
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pradaxa® prescribers (cardiologists and primary care physicians) * Patients with atrial fibrillation treated with Pradaxa®
Exclusion criteria
As defined in Summary of Product Characteristics for patients treated with Pradaxa®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) | Day 1 | The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing. This Outcome measure is applicable only for the Physicians group. |
| Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) | Day 1 | The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group. |
Countries
Bulgaria, Czechia, Denmark, France, Germany, Slovakia, Spain, United Kingdom
Participant flow
Recruitment details
This is a cross-sectional survey. Pradaxa® prescribing healthcare professionals and Pradaxa® treated patients were randomly selected and interviewed (face-to-face). 411 healthcare professionals and 802 patients with atrial fibrillation were enrolled and entered the study
Participants by arm
| Arm | Count |
|---|---|
| Physicians Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF). | 411 |
| Patients AF patients on treatment with Pradaxa®. | 802 |
| Total | 1,213 |
Baseline characteristics
| Characteristic | Physicians | Patients | Total |
|---|---|---|---|
| Age, Customized <75 years | NA Participants | 480 Participants | NA Participants |
| Age, Customized ≥ 75 years | NA Participants | 322 Participants | NA Participants |
| Sex: Female, Male Female | NA Participants | 370 Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | 432 Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)
The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.
Time frame: Day 1
Population: AF patients on treatment with Pradaxa®.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients | Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) | A | 55 Percentage of Participants |
| Patients | Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) | B | 83 Percentage of Participants |
| Patients | Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) | C | 100 Percentage of Participants |
| Patients | Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) | E | 54 Percentage of Participants |
| Patients | Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) | D | 89 Percentage of Participants |
| Patients | Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) | F | 52 Percentage of Participants |
Primary
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)
The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing. This Outcome measure is applicable only for the Physicians group.
Time frame: Day 1
Population: Physicians who were current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Physicians | Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) | A | 65 Percentage of Participants |
| Physicians | Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) | B | 71 Percentage of Participants |
| Physicians | Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) | C | 95 Percentage of Participants |
| Physicians | Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) | D | 100 Percentage of Participants |