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

NCT ID: NCT03645564

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2022-06-13

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Specialized nurse consultation

Intervention Type: OTHER

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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

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,

• Minimum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélie PETIT-MONEGER, MD

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Pessac, , France

Countries

France

Other Identifiers

CHUBX 2016/43

Identifier Type: -

Identifier Source: org_study_id