Better Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program

Study Overview
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Brief Summary
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This study is multicentric, single-blind, and interventional with a randomization into two parallel arm, between a standard of care information and an additional information of the patient, with a 12 month follow up. The aim of this study is to evaluate the effectiveness of a personalized information program versus information provided from standard of care in patients taking Xarelto for Stroke Prevention in Atrial Fibrillation.

Conditions
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Non-valvular Atrial Fibrillation

Intervention / Treatment
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* Drug: Xarelto
* Other: Experimental: Personalized information intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients treated with rivaroxaban chronically, (atrial fibrillation non-valvular under current AMM) for less than one year whatever anti vitamin K treatment history Affiliate or beneficiary of a social security system. Patient who formulated its does not oppose to participate in this research Age higher than or equal to 18 years Exclusion Criteria: Opposition to participation Patient don't understand french language Patient does not have responsibility for the management of treatment (treatment administered by a nurse at home, or by caregivers) Tutorship or curatoship Law-protected patient Pregnant women or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Taking conventional charge<br>No further information is given to the patient during the first and only contact with the nurse of the coordinator center. A time will be dedicated by the IDE to answer questions of the patient. | Drug: Xarelto<br>* Taking conventional charge<br>|
| Experimental: Personalized information intervention<br>The intervention of personalized information will be made as appropriate to the patient's needs and will include: Personalized telephone information carried by a nurse trained in therapeutic education. A time will be dedicated by the IDE to answer questions of the patient. The delivery of paper documents, a list of recommended websites and phone remote monitoring will be performed by the nurse at J30 and J45 to check understanding of the information provided, the actual reading of the paper documents, or effective consultation of websites. A time will be dedicated by the IDE to answer questions at the remote monitoring of the patient to J30 and J45. | Other: Experimental: Personalized information intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurence of serious adverse event | The occurence of serious adverse event | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number ok hospitalization | The number ok hospitalization | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients, treated by Rivaroxaban