Adherence to New Oral Anticoagulation Therapy in Turkey

Atrial Fibrillation Clinical Trial

— NOAC-TR  

Official title:

Drug Adherence in Patients Taking New Oral Anticoagulation Therapy in Turkey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480920
• Other study ID #: NOAC-TR
• Status: Completed
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2019
• Source: Cardiovascular Academy Society, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2738
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Turkey	Volkan Emren	Afyonkarahi?sar

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovascular Academy Society, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	10 months