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This study will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkish Population.
NOACs have several clinical and pharmacological advantages over warfarin however suboptimal adherence is one of the most common causes of failure to respond to medications and outcomes.
This observational multicenter, retrospective study, will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkey.
Social support and adherence to therapy factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires.
Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors.
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| Measure | Description | Time Frame |
|---|---|---|
| Compliance of NOACs in Turkish Population | Factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires. Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors. The validity of the Morisky Adherence Scale had already been demonstrated with regard to medication adherence in patients receiving vitamin K antagonists. An extended 8-item Morisky scale was used instead of the original 4-item Morisky scale in order to better identify the situations and the conditions that could affect medication adherence and to better assess the psychometric features.The reliability and the validity of the 8-item Morisky Adherence Scale translated into Turkish had been demonstrated in Turkish population by previous studies. | 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation
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| Name | Affiliation | Role |
|---|---|---|
| Volkan Emren, MD | Cardiovascular Academy Society, İzmir, Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Volkan Emren | Afyonkarahisar | Turkey (Türkiye) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Popülation: Who Received NOAC for More Than 3 Months | This multicenter cross-sectional study was conducted between September 2015 and February 2016 in 45 centers encompassing all the geographical regions of Turkey. A total of 3150 patients were evaluated in this study. The 163 patients with a sociocultural level inadequate to fill the questionnaire and the 249 patients who received new oral anticoagulant for less than 3 months were excluded from the study. This study was conducted with the remaining 2738 patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Population | This multicenter cross-sectional study was consisted of patients who with non-valvular atrial fibrillation (NVAF) receiving Non-vitamin K antagonist oral anticoagulants NOACs), older than 18 years, who were followed up in cardiology clinics, and who received dabigatran (110-150 mg), rivaroxaban (15-20 mg), or apixaban (2.5-5 mg) for the last 3 months with >30 days of supply due to NVAF. The patients were categorized into 2 groups as adherent patients who had high and medium adherence (Morisky score 6 or more) and non-adherent patients who had low adherence (Morisky score 5 or less). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Compliance of NOACs in Turkish Population | Factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires. Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors. The validity of the Morisky Adherence Scale had already been demonstrated with regard to medication adherence in patients receiving vitamin K antagonists. An extended 8-item Morisky scale was used instead of the original 4-item Morisky scale in order to better identify the situations and the conditions that could affect medication adherence and to better assess the psychometric features.The reliability and the validity of the 8-item Morisky Adherence Scale translated into Turkish had been demonstrated in Turkish population by previous studies. | Posted | Count of Participants | Participants | 10 months |
|
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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 | Advers Events | The adverse effects, stroke, and any bleeding complication during NOAC treatment. Major bleeding was defined as a hemorrhage leading to a reduction in hemoglobin concentration of 2 g/dL, necessitating the transfusion of 2 or more units of blood, or symptomatic bleeding into a critical area or organ. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Volkan Emren | Department of Cardiology, Afyonkarahisar State Hospital, Afyonkarahisar, Turkey | vemren@hotmail.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 687 |
| 2,738 |
| 0 |
| 2,738 |
| Bleeding | General disorders | Systematic Assessment | Any bleeding (major or minor) complication during NOAC treatment. |
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| Systemic Embolism | Vascular disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |