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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).
Secondary Study Objective(s)
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).
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with high bleeding risk, including patients with:
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Primary patients with non-valvular atrial fibrillation included in the outpatient registry PROFILE during the period 01.01.2011-31.08.2015.
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| Name | Affiliation | Role |
|---|---|---|
| Sergey Martsevich, MD,PhD | National Research Center of Preventive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Center for Preventive Medicine | Moscow | 101990 | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | ANTEY | Patients with AF from the "PROFILE" registry were included. 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 all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ANTEY | Patients with AF from the "PROFILE" registry were included. 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 all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 6 months |
|
1 year
All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ANTEY | Patients with AF from the "PROFILE" registry were included. 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 all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myiocardial infarction | Cardiac disorders | Systematic Assessment | Non-fatal AMI |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | General disorders | Systematic Assessment | Bleeding of different localization due to NOAC therapy, non-severe |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| professor Sergey Yu. Martsevich | National Medical Research Center for Preventive Medicine | 89161643690 | sergeymartsevich@mail.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2016 | May 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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.
|
| 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. | 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). | 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. | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| NOAC recommended to patients by doctors during V0 | Count of Participants | Participants |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC) |
|
|
|
| Secondary | 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.
| Posted | Count of Participants | Participants | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC) |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC) |
|
|
|
| 4 |
| 201 |
| 21 |
| 201 |
| 30 |
| 201 |
| Unstable angina pectoris | Cardiac disorders | Systematic Assessment |
|
| CHF decompensation | Cardiac disorders | Systematic Assessment | Hospitalization due to CHF decompensation |
|
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Paroxysm of atrial fibrillation | Cardiac disorders | Systematic Assessment | Paroxysm of atrial fibrillation, emergency hospitalization |
|
| Stroke | Nervous system disorders | Systematic Assessment |
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| Bleeding in the retina | Eye disorders | Non-systematic Assessment | Bleeding in the retina, emergency hospitalization |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment | Severe iron deficiency anaemia, emergency hospitalization |
|
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Urticaria | Immune system disorders | Systematic Assessment |
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| Obstipation | Gastrointestinal disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment | amiodarone-induced hypothyroidism |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gynecomastia | Reproductive system and breast disorders | Systematic Assessment | Spironolactone-induced gynecomastia |
|
| Arterial hypotension | Cardiac disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| completely non-adherent |
|
| adherence to Warfarin |
|
| adherence to another NOAC |
|
| difficult regimen for all drugs |
|
| lack of NOAC in the preferential drug list |
|
| others |
|