A prospective non-interventional single-centre study aimed to evaluate actual adherence of AF patients using the validated adherence Scale. Primary Study Objective(s) Primary study objective The aim of the present study is to assess adherence to therapy and factors associated with adherence in patients with CV disease complicated by non-valvular atrial fibrillation requiring OAC treatment within the outpatient registry PROFILE (prospective, observational study). 1. Data collection in patients with non-valvular atrial fibrillation requiring OAC treatment included in the registry 2. Evaluation of actual patient adherence to OACs Secondary Study Objective(s) 1. Evaluation of potential patient adherence to OACs 2. Determination of the most significant factors associated with adherence to OACs in patients with non-valvular AF 3. Validation of new original 5-item Questionnaire 4. Evaluation of doctor's adherence to OAC prescription according to Guidelines (ESC). Management of atrial fibrillation,2016)
AF patients from ongoing PROFILE registry will be invited to visit the scientific center. 2 visits with a 6-month interval are expected for each patient as part of routine clinical practice and phone contact is scheduled for each patient 1 year from the first visit to the scientific center (follow-up period).
Study Type
OBSERVATIONAL
Enrollment
201
National Research Center for Preventive Medicine
Moscow, Russia
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)
The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during V1 with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.
Time frame: 6 months
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)
The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during phone contact with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale. Out of 201 participants of the study 4 patients died and 197 patients completed the study.
Time frame: 1 year
Proportion of Potentially Adherent Patients
Specifically designed 5-item questionnaire was used for assessment of potential adherence to OACs. According to results patients were divided into groups: completely adherent, partially adherent, completely non-adherent to OACs.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Proportion of OACs Prescribed by Doctors According to Guidelines
Prescription of OACs according to guidelines was considered "positive" if it matched the key points of 2016 ESC Guidelines for the management of atrial fibrillation. 1. Oral anticoagulation therapy to prevent thromboembolism is recommended for all male AF patients with a CHA2DS2-VASc score of 2 or more. 2. Oral anticoagulation therapy to prevent thromboembolism is recommended in all female AF patients with a CHA2DS2-VASc score of 3 or more. 3. Antiplatelet monotherapy is not recommended for stroke prevention in AF patients, regardless of stroke risk. 4. NOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) are not recommended in patients with mechanical heart valves (Level of evidence B) or moderate-to-severe mitral stenosis (Level of evidence C). 5. In male or female AF patients without additional stroke risk factors, anticoagulant or antiplatelet therapy is not recommended for stroke prevention.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
The Main Reasons for Refusing to Start NOAC Therapy
The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients refusing to start NOAC treatmet were asked about the reasons to refuse NOAC treatment.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Reasons for Stopping Oral Anticoagulants (Data From Visit 1)
The study consisted of two visits half a year apart (V0, V1) and phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped or didn't start NOAC treatment were asked about the reasons for non-adherence to anticoagulants use during visit 1 (6 months) and at PC (1 year).
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)
The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped NOAC treatmet were asked about the reasons for stopping oral anticoagulants (NOAC and warfarin) use during the phone contact.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
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