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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Specialized nurse consultation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 588 participants
Allocation: Randomized
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


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.
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.



Primary Outcome Measures :
  1. Adherence to direct oral anticoagulants [ Time Frame: 12 months ]
    Adherence questionnaire


Secondary Outcome Measures :
  1. Change in the level of knowledge of disease and treatment [ Time Frame: Change from baseline at 12 months ]
    Assessment by auto-questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Contacts
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Contact: Geneviève BULIDON (0)557675604 ext +33 genevieve.bulidon@chu-bordeaux.fr
Contact: Maider PIQUET (0)557623398 ext +33 maider.piquet@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux
Pessac, France, 33604
Contact: Geneviève BULIDON    (0)557675604 ext +33    genevieve.bulidon@chu-bordeaux.fr   
Contact: Maider PIQUET    (0)557623398 ext +33    maider.piquet@chu-bordeaux.fr   
Principal Investigator: Geneviève BULIDON         
Sub-Investigator: Hélène MARQUESTAUT         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Aurélie PETIT-MONEGER, MD University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03645564    
Other Study ID Numbers: CHUBX 2016/43
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Stroke
Anti-vitamin K
Direct anti-coagulant
Nurse
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes