Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation Drug Adherence, New Oral Anticoagulants, Drug Adherence
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Cardiovascular Academy Society, Turkey
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>18 years old * Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation * Patients signed patient informed sheet and informed consent form
Exclusion criteria
* Patients under 18 years old * Patients refused to sign informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance of NOACs in Turkish Population | 10 months | 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. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 2,738 |
| Total | 2,738 |
Baseline characteristics
| Characteristic | Study Population |
|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 1623 Participants |
| Sex: Female, Male Male | 1115 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,738 |
| serious Total, serious adverse events | 687 / 2,738 |
Outcome results
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.
Time frame: 10 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Popülation: Who Received NOAC for More Than 3 Months | Compliance of NOACs in Turkish Population | low adherence | 1342 Participants |
| Study Popülation: Who Received NOAC for More Than 3 Months | Compliance of NOACs in Turkish Population | high and medium adherence | 1036 Participants |