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

University Hospital Center (CHU)

Status: Completed

Conditions: Non-valvular Atrial Fibrillation

Treatments: Other: Experimental: Personalized information intervention; Drug: Xarelto

Study type: Interventional

Funder types: Other

Identifiers

NCT02422602

9120

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

Taking conventional charge

Active Comparator group

Description:

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.

Treatment:

Drug: Xarelto

Personalized information intervention

Experimental group

Description:

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.

Treatment:

Other: Experimental: Personalized information intervention