Overview

This trial is active, not recruiting.

Condition non-valvular atrial fibrillation
Treatments xarelto, experimental: personalized information intervention
Sponsor University Hospital, Montpellier
Start date November 2013
End date May 2015
Trial size 196 participants
Trial identifier NCT02422602, 9120

Summary

This study is multicentric, single-blind, and interventionnal with a randomization into two parallel arm, between a standard of care information and an additionnal information of the patient, with a 12 month follow up.

The aim of this study is to evaluate the effectiveness of a personalized information programm versus information provided from standard of care in patients taking Xarelto for Stroke Prevention in Atrial Fibrillation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
Arm
(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.
xarelto
Taking conventional charge
(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.
experimental: personalized information intervention

Primary Outcomes

Measure
Morisky Medication Adherence Scale
time frame: 12 months

Secondary Outcomes

Measure
Morisky Medication Adherence Scale
time frame: 6 months
OAC questionnaire
time frame: At 6 and 12 months
The occurrence of serious adverse event
time frame: 12 months
The number of hospitalization
time frame: 12 months
The occurrence of hemorrhagic stroke
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University Hospital, Montpellier.