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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT02422602

Collaborator

(none)

196

Enrollment

Location

Arms

29.3

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-valvular Atrial Fibrillation	Drug: Xarelto Other: Experimental: Personalized information intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

196 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Actual Study Start Date :

Nov 26, 2013

Actual Primary Completion Date :

May 6, 2015

Actual Study Completion Date :

May 6, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Xarelto Taking conventional charge
Experimental: 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.	Other: Experimental: Personalized information intervention

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Xarelto

Taking conventional charge

Experimental: 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.

Other: Experimental: Personalized information intervention

Outcome Measures

Primary Outcome Measures

The occurence of serious adverse event [12 months]
The occurence of serious adverse event

Secondary Outcome Measures

The number ok hospitalization [12 months]
The number ok hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart and vascular diseases service	Montpellier		France	34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT02422602

Other Study ID Numbers:

9120

First Posted:

Apr 21, 2015

Last Update Posted:

Jul 26, 2021

Last Verified:

Apr 1, 2020

Keywords provided by University Hospital, Montpellier

Patients

treated by Rivaroxaban

Additional relevant MeSH terms:

Atrial Fibrillation

Rivaroxaban

Study Results

No Results Posted as of Jul 26, 2021