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

NCT ID: NCT02422602

Last Updated: 2021-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-26
• Study Completion Date: 2016-05-06

Brief Summary

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

Non-valvular Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Taking conventional charge

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.

Group Type: ACTIVE_COMPARATOR

Xarelto

Intervention Type: DRUG

Taking conventional charge

Personalized information intervention

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.

Group Type: EXPERIMENTAL

Experimental: Personalized information intervention

Intervention Type: OTHER

Interventions

Xarelto

Taking conventional charge

Intervention Type: DRUG

Experimental: Personalized information intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Heart and vascular diseases service

Montpellier, , France

Countries

France

Other Identifiers

9120

Identifier Type: -

Identifier Source: org_study_id