Back to resultsBetter Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program (MONACO)
Primary Purpose
Non-valvular Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Xarelto
Experimental: Personalized information intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Non-valvular Atrial Fibrillation focused on measuring Patients, treated by Rivaroxaban
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
Sites / Locations
- Heart and vascular diseases service
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Taking conventional charge
Personalized information intervention
Arm 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.
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.
Outcomes
Primary Outcome Measures
The occurence of serious adverse event
The occurence of serious adverse event
Secondary Outcome Measures
The number ok hospitalization
The number ok hospitalization
Full Information
NCT ID
NCT02422602
First Posted
April 13, 2015
Last Updated
July 19, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02422602
Brief Title
Better Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program
Acronym
MONACO
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 26, 2013 (Actual)
Primary Completion Date
May 6, 2015 (Actual)
Study Completion Date
May 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-valvular Atrial Fibrillation
Keywords
Patients, treated by Rivaroxaban
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Taking conventional charge
Arm Type
Active Comparator
Arm 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.
Arm Title
Personalized information intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Xarelto
Intervention Description
Taking conventional charge
Intervention Type
Other
Intervention Name(s)
Experimental: Personalized information intervention
Primary Outcome Measure Information:
Title
The occurence of serious adverse event
Description
The occurence of serious adverse event
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The number ok hospitalization
Description
The number ok hospitalization
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Heart and vascular diseases service
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Learn more about this trial
Better Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program
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