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Completed

NCT Number: NCT02480920

Adherence to New Oral Anticoagulation Therapy in Turkey

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Behavior Cardiovascular Diseases Health Behavior Heart Diseases Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Volkan Emren

Afyonkarahisar, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Compliance of NOACs in Turkish Population

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cardiovascular Academy Society, Turkey

Other

Registry information

Official study title

Drug Adherence in Patients Taking New Oral Anticoagulation Therapy in Turkey

Acronym: NOAC-TR

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2015
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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