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

NCT03645564 | Terminated

• 1 other identifier: CHUBX 2016/43
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Stroke; Anti-vitamin K; Direct anti-coagulant; Nurse

Outcome Measures

Primary Outcomes (1)

• Adherence to direct oral anticoagulants

  Adherence questionnaire

  12 months

Secondary Outcomes (1)

• Change in the level of knowledge of disease and treatment

  Change from baseline at 12 months

Study Arms (2)

Group 1 : specialized nurse consultation

ACTIVE COMPARATOR

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

Group 2 : no specialized nurse consultation

NO INTERVENTION

This control group will present the same care pathway than all the patients of the service suffering from Atrial Fibrillation without specialized nurse consultation.

Interventions

Specialized nurse consultation 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 1 : specialized nurse consultation

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Subject deprived of liberty by judicial or administrative decision,
• Protected adults,

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Pessac, 33604, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Aurélie PETIT-MONEGER, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 24, 2018
• Study Start: October 16, 2018
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

FR (1)