Adherence to New Oral Anticoagulation Therapy in Turkey

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02480920
• Lead Sponsor: Cardiovascular Academy Society, Turkey

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.

Study Timeline

• Study First Submitted: 2015-06-19
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-25
• Study Start: 2015-07
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Results First Submitted: 2017-11-27
• Results First Submitted QC: 2018-08-22
• Results First Posted: 2019-01-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2738

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Volkan Emren; 🇹🇷 Afyonkarahi̇sar, Turkey