Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04674202
Other study ID # 2020PPRC08
Secondary ID 2020-A02285-34
Status Recruiting
Phase
First received
Last updated
Start date January 18, 2021
Est. completion date January 2024

Study information

Verified date September 2022
Source Direction Centrale du Service de Santé des Armées
Contact Samuel COHEN
Phone 635192704
Email samuel.cohen4@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Direct oral anticoagulants (Rivaroxaban, Apixaban and Dabigatran) are an alternative to anti-vitamin K drugs and low molecular weight heparins in many cardiovascular diseases. This new class of anticoagulants represents a particular and very promising advance: they are administered orally, their mechanism of action is rapid and direct on coagulation and their predictable pharmacological action allows for administration at fixed doses. In contrast to anti-vitamin K, there is no need for routine biological monitoring. However, their therapeutic range is narrow and there is no routine biological monitoring. Rigorous compliance is therefore necessary. In addition, there are no official validated recommendations either for the measurement of anticoagulant activity in certain emergency situations, or for the management of severe bleeding (except recently for Pradaxa®). Their correct use requires the training and involvement of health professionals as well as information and support for patients. Pharmaceutical interviews are one of the main ways in which pharmacists can ensure this security through personalized and optimal patient care. The purpose of these interviews is to: - Reinforce the pharmacist's advisory, educational and preventive roles with patients; - To enhance the pharmacist's expertise in the area of medication; - To evaluate the patient's knowledge of his or her treatment; - To assess the patient's knowledge of his or her treatment; To seek the patient's therapeutic adherence and help him or her to take ownership of his or her treatment; - To evaluate, in the long term, the patient's appropriation of his or her treatment. In this way, they enable involvement with patients while providing a link between healthcare professionals, which is essential for optimal patient care. In recent years, numerous studies have been conducted on pharmaceutical interviews in the United Kingdom and the Netherlands. On the other hand, few studies have been conducted in France to evaluate the clinical impact of pharmaceutical interviewing in medical services. The aim of this study is to compare patients' knowledge of direct oral anticoagulants between 2 cardiology departments offering or not a pharmaceutical interview.


Recruitment information / eligibility

Status Recruiting
Enrollment 154
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient hospitalized for more than 48 hours in a cardiology department with a discharge prescription for curative anticoagulation. - Indication for a direct oral anticoagulant for atrial fibrillation, deep vein thrombosis or pulmonary embolism Exclusion Criteria: - Patients treated for the prevention of venous thromboembolic disease who have undergone scheduled total hip replacement or total knee replacement surgery. - Patient with cognitive impairment - Patients with a previous prescription for a direct oral anticoagulant

Study Design


Intervention

Other:
Phone interview
The participant will have 2 phone interview in which they will be asked about their knowledge of direct oral anticoagulants.

Locations

Country Name City State
France Centre Hospitalier Intercommunal de Montreuil Montreuil
France Hôpital d'Instruction des Armées Bégin Saint-Mandé

Sponsors (1)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with a "satisfactory" knowledge score 3 months after hospital discharge Knowledge of direct oral anticoagulants will be assessed with a 4 item questionnaire. The score ranges from 0 "no knowledge" to = 3 "satisfactory knowledge". 3 months after hospital discharge
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A