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临床试验/NCT02480920
NCT02480920已完成不适用

Drug Adherence in Patients Taking New Oral Anticoagulation Therapy in Turkey

Cardiovascular Academy Society, Turkey1 个研究点 分布在 1 个国家目标入组 2,738 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,738
试验地点
1
主要终点
Compliance of NOACs in Turkish Population

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients under 18 years old
  • Patients refused to sign informed consent form

结局指标

主要结局

Compliance of NOACs in Turkish Population

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Cardiovascular Academy Society, Turkey
申办方类型
Other
责任方
Sponsor

研究点 (1)

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