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

NCT02422602 | Completed

• 1 other identifier: 9120
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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

Keywords

Patients; treated by Rivaroxaban

Outcome Measures

Primary Outcomes (1)

• The occurence of serious adverse event

  The occurence of serious adverse event

  12 months

Secondary Outcomes (1)

• The number ok hospitalization

  12 months

Study Arms (2)

Taking conventional charge

ACTIVE COMPARATOR

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

Personalized information intervention

EXPERIMENTAL

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

Interventions

Xarelto DRUG

Taking conventional charge

Taking conventional charge

Experimental: Personalized information intervention OTHER

Personalized information intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Heart and vascular diseases service

Montpellier, 34295, France

Location

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 21, 2015
• Study Start: November 26, 2013
• Primary Completion: May 6, 2015
• Study Completion: May 6, 2016
• Last Updated: July 26, 2021

Record last verified: 2020-04

Locations

FR (1)