Adherence to Oral Anticoagulants in Patients With Atrial Fibrillation (3AOD)
Primary Purpose
Oral Anticoagulant, Adherence
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionary
Sponsored by
About this trial
This is an interventional other trial for Oral Anticoagulant focused on measuring Direct oral anticoagulant, Adherence, Proportion of days covered, adherence questionary, Girerd adherence questionary
Eligibility Criteria
Inclusion Criteria:
- Over the age of 18
- Consultation in the community pharmacy
- long-term treatment for at least six months with an DOACs.
- Patients able and agreeing to participate in the evaluation of their adherence
Exclusion Criteria:
- Treatment by DOACs limited in the duration
- Contra-indications of DOACs
Sites / Locations
- CHU AmiensRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
questionary
Arm Description
Outcomes
Primary Outcome Measures
Number of AOD specific PDC
Determination of the AOD (Direct oral anticoagulants) specific PDC (Proportion of Days Covered) of patients coming to renew their treatment in the community pharmacy
Secondary Outcome Measures
Full Information
NCT ID
NCT05469308
First Posted
July 19, 2022
Last Updated
July 27, 2022
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05469308
Brief Title
Adherence to Oral Anticoagulants in Patients With Atrial Fibrillation
Acronym
3AOD
Official Title
Predictivity and Evaluation of the Adherence of Ambulatory Patients Treated With a Direct Oral Anticoagulant for Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The rhythm disorders of Atrial Fibrillation (AF) require continuous treatment with anticoagulants to prevent stroke. The introduction of direct oral anticoagulants (DOACs) quickly supplanted the administration of anti-vitamin K (AVK) which presented an elevated risk of hemorrhage.
However, the adherence of the treatments by the OAD is very poor, several studies show that 30 to 50% of the patients fail to adhere to their treatment very soon after starting it. In a recent study, in the United States, using data collected between 2010 and 2014 in more than 60,000 patients with AF, Yao et al show that less than 50% of patients can be considered "adherent".
They conclude in this study that adherence to anticoagulation is low in practice, although it may be slightly improved with DOACs. More recently a meta-analysis shows that 66% of patient treated by DOACs were considered adherent (PDC > 80 %). In addition, therapeutic adherence seems to be essential in patients with a CHA2DS2-VASc score ≥2. Indeed improving adherence reduces the risk of stroke occurrence. The investigators propose to evaluate during an interview in the pharmacy, the adherence of ambulatory patients (at the time of their renewal of treatment at the pharmacy) by the "Proportion of Days Covered" (PDC) of the treatment by AOD, and by a simplified questionnaire and to define a profile of patients treated for AF at risk of nonadherence to AOD (PDC adherence prediction score). The investigators perform an observational, prospective multicenter study , in which patients adherence will be quantified in a standardized method.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Anticoagulant, Adherence
Keywords
Direct oral anticoagulant, Adherence, Proportion of days covered, adherence questionary, Girerd adherence questionary
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
705 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
questionary
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
questionary
Intervention Description
When the patients renew their treatment in community pharmacy, they have an adherence record with a pharmacist who calculates the PDC score, and perform questionaries on adherence to the DOACs, and collects data about clinical history and pharmacological information on the prescribed DAOCs, demography.
Primary Outcome Measure Information:
Title
Number of AOD specific PDC
Description
Determination of the AOD (Direct oral anticoagulants) specific PDC (Proportion of Days Covered) of patients coming to renew their treatment in the community pharmacy
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over the age of 18
Consultation in the community pharmacy
long-term treatment for at least six months with an DOACs.
Patients able and agreeing to participate in the evaluation of their adherence
Exclusion Criteria:
Treatment by DOACs limited in the duration
Contra-indications of DOACs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurelien MARY, Pr
Phone
03.22.08.83.71
Email
mary.aurelien@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélien Mary, Pr
Phone
03.22.08.83.71
Email
mary.aurelien@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Christophe Tribouilloy, Pr
First Name & Middle Initial & Last Name & Degree
Michel Brazier, Pr
First Name & Middle Initial & Last Name & Degree
Charlotte Debanne, MD
First Name & Middle Initial & Last Name & Degree
Aurélie Terrier-Lenglet, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adherence to Oral Anticoagulants in Patients With Atrial Fibrillation
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