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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Stroke
Anti-vitamin K
Direct anti-coagulant
Nurse
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Eligibility 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).

Primary outcomes:
measure: Adherence to direct oral anticoagulants
timeFrame: 12 months
Secondary outcomes:
measure: Change in the level of knowledge of disease and treatment
timeFrame: Change from baseline at 12 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Aurélie PETIT-MONEGER, MD
role: STUDY_CHAIR
References: