Evaluation the Effectiveness of the Risk Minimisation Act... | NCT02433366

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Day 1
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.	Day 1

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site 81		Dobrich			Bulgaria
Boehringer Ingelheim Investigational Site 84

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Physicians	Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
FG001	Patients	AF patients on treatment with Pradaxa®.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Physicians	Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
BG001	Patients	AF patients on treatment with Pradaxa®.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000NAInformation about physicians gender is not available BG001370 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Physicians who were current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF)

Posted

Number

Percentage of Participants

Day 1

ID	Title	Description
OG000	Physicians	Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
OG001	Patients	AF patients on treatment with Pradaxa®.

Units	Counts
Participants	OG000411 OG0010

Title

Denominators

Categories

Title	Measurements
	OG00065

Title	Measurements
	OG00071

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.

AF patients on treatment with Pradaxa®.

Posted

Number

Percentage of Participants

Day 1

ID	Title	Description
OG000	Physicians	Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
OG001	Patients	AF patients on treatment with Pradaxa®.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Physicians	Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).			0	0	0	0
EG001	Patients	AF patients on treatment with Pradaxa®.			0	0	0	0

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms