Atrial FibrillationEDUC-AODNCT04674202
Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants in Post-hospitalization Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview During Hospitalization
An observational study of Atrial Fibrillation and Deep Vein Thrombosis, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism
- What is being tested?
- Phone interview
- Type of treatment
- Pill or oral medicine
- How many people
- 154 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Jan 2021to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is composed of patients hospitalized in a cardiology department with a discharge prescription for direct oral anticoagulants.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Intercommunal de Montreuil
Montreuil, 93100
Albert BOCCARA, MD, 951706247 ext. +33, albert.boccara@gmail.com
- Recruiting
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160
François BOUVIER, MD, francois-rene.bouvier@intradef.gouv.fr
About this study
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.
Read more
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.
- Being tested
- Phone interview
- Keywords
- Direct oral anticoagulants
- Medical subject headings
- Atrial Fibrillation, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone interviewOther
The participant will have 2 phone interview in which they will be asked about their knowledge of direct oral anticoagulants.
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical interview | This group will benefit from a pharmaceutical interview, accordingly with the common practice in the department in which they are treated. Receives: Other: Phone interview | |
| No pharmaceutical interview | This group will not benefit from a pharmaceutical interview, accordingly with the common practice in the department in which they are treated. Receives: Other: Phone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 3 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start18 Jan 2021
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674202
- Sponsor's protocol ID
- 2020PPRC08
- Other IDs
- 2020-A02285-34
- Acronym
- EDUC-AOD
- Status last verified
- Sep 2022
- First submitted
- 14 Dec 2020
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants in Post-hospitalization Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview During Hospitalization
- ClinicalTrials.gov ID
- NCT04674202
- Acronym / sponsor ID
- EDUC-AOD / 2020PPRC08
- Keywords
- Direct oral anticoagulants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical interview | – | Other: Phone interviewThis group will benefit from a pharmaceutical interview, accordingly with the common practice in the department in which they are treated. |
| No pharmaceutical interview | – | Other: Phone interviewThis group will not benefit from a pharmaceutical interview, accordingly with the common practice in the department in which they are treated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of patients hospitalized in a cardiology department with a discharge prescription for direct oral anticoagulants.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone interviewThe participant will have 2 phone interview in which they will be asked about their knowledge of direct oral anticoagulants. | Other | No pharmaceutical interview, Pharmaceutical interview |
Primary outcome
Proportion of patients with a "satisfactory" knowledge score 3 months after hospital discharge
Time frame: 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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Deep Vein Thrombosis, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel COHEN (635192704 ext. +33, samuel.cohen4@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a "satisfactory" knowledge score 3 months after hospital discharge (time frame: 3 months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.