- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645564
Impact of the Information Follow-up Given to Patients on Their Disease Understanding and Therapeutic Adherence in Patients Under Direct Oral Anticoagulants and With Atrial Fibrillation in a Cardiology Department (RYTHM-UP AOD)
February 1, 2024 updated by: University Hospital, Bordeaux
The primary objective of this study is to measure in patients addressed for Atrial Fibrillation (AF) in the Cardiology-Electrophysiology and Cardiac Stimulation Department of Bordeaux hospital, the impact of a specialized nurse consultation on their adherence level to direct oral anticoagulants treatments.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The number of persons that should take an anticoagulant treatment in France is evaluated at 3 Billion and at least half of them for an Atrial Fibrillation disease.
One of the main issues of their prescription is stoke prevention.
With the coming of direct oral anticoagulants, which does not require repeating controls like it is the case for anti-vitamin K treatments, the patient's involvement is a guarantee of therapeutic adherence and good use.
Nevertheless a good adherence level is seldom reached.
This highlights the importance of individualized information which must be followed for purposes of accuracy and deepening.
Thus as part of investigator's activity department that treats about 1000 patients per year for an Atrial Fibrillation, the information, use and therapeutic adherence are a priority in the care pathway of patients under direct oral anticoagulants.
The investigators propose to measure the contribution of a specialized nurse consultation in contact with a multidisciplinary team on therapeutic adherence.
The investigators hypothesis that an individualized and reassessed information would allowed a better understanding by the patients of their pathology and care and thus a better therapeutic adherence.
A control group will present the same care pathway than all the patients of the service suffering from Atrial Fibrillation without specialized nurse consultation.
The second group will benefit of a specialized nurse consultation throughout of which an individualized information will be delivered.
This information will be reevaluated during the usual patient follow-up.
All the patients will be followed at 3 months, 6 months and 1 year as part of the usual care of the service.
Study Type
Interventional
Enrollment (Actual)
221
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pessac, France, 33604
- CHU de Bordeaux
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient hospitalized in the Cardiology-Electrophysiology and Cardiac Stimulation Department for an AF,
- Patient requiring direct oral anticoagulant treatment,
- Age ≥ 18 years of both genders,
- Written consent,
- Patient affiliated or beneficiary of a social insurance,
- French language.
Exclusion Criteria:
- Patient unable to give his written consent or with cognitive disorders,
- Patient depending of a third person,
- Patient unable to be followed in the service,
- Patient in exclusion period for another protocol,
- Subject deprived of liberty by judicial or administrative decision,
- Protected adults,
- Non-inclusion criteria specific to direct oral anticoagulants (valvular AF, severe renal impairment).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1 : specialized nurse consultation
This group will benefit of a specialized nurse consultation throughout of which an individualized information will be delivered.
This information will be reevaluated during the usual patient follow-up.
|
The purpose of this consultation is to establish a partnership between the patient and the nursing staff.
Tools were set up (notebook, movie) to answer the questions of the patient.
In case of specific question, an expert will meet the patient (doctor of the service, psychologist, pharmacist or hematologist).
|
No Intervention: Group 2 : no specialized nurse consultation
This control group will present the same care pathway than all the patients of the service suffering from Atrial Fibrillation without specialized nurse consultation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to direct oral anticoagulants
Time Frame: 12 months
|
Adherence questionnaire
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the level of knowledge of disease and treatment
Time Frame: Change from baseline at 12 months
|
Assessment by auto-questionnaire
|
Change from baseline at 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Aurélie PETIT-MONEGER, MD, University Hospital, Bordeaux
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 16, 2018
Primary Completion (Actual)
June 13, 2022
Study Completion (Actual)
June 13, 2022
Study Registration Dates
First Submitted
August 20, 2018
First Submitted That Met QC Criteria
August 22, 2018
First Posted (Actual)
August 24, 2018
Study Record Updates
Last Update Posted (Actual)
February 2, 2024
Last Update Submitted That Met QC Criteria
February 1, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2016/43
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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