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)
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|ClinicalTrials.gov Identifier: NCT03645564|
Recruitment Status : Unknown
Verified August 2018 by University Hospital, Bordeaux.
Recruitment status was: Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Other: Specialized nurse consultation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||588 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||It is an open, prospective, randomized, 2 arms study that will compare 2 groups of patients care for Atrial Fibrillation in the Cardiology-Electrophysiology and Cardiac Stimulation Department with direct oral anticoagulants prescription.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
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.
Other: Specialized nurse consultation
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.
- Adherence to direct oral anticoagulants [ Time Frame: 12 months ]Adherence questionnaire
- Change in the level of knowledge of disease and treatment [ Time Frame: Change from baseline at 12 months ]Assessment by auto-questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645564
|Contact: Geneviève BULIDON||(0)557675604 ext +firstname.lastname@example.org|
|Contact: Maider PIQUET||(0)557623398 ext +email@example.com|
|CHU de Bordeaux|
|Pessac, France, 33604|
|Contact: Geneviève BULIDON (0)557675604 ext +33 firstname.lastname@example.org|
|Contact: Maider PIQUET (0)557623398 ext +33 email@example.com|
|Principal Investigator: Geneviève BULIDON|
|Sub-Investigator: Hélène MARQUESTAUT|
|Study Chair:||Aurélie PETIT-MONEGER, MD||University Hospital, Bordeaux|