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Clinical Trials/NCT02480920
NCT02480920
Completed
Not Applicable

Drug Adherence in Patients Taking New Oral Anticoagulation Therapy in Turkey

Cardiovascular Academy Society, Turkey1 site in 1 country2,738 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Cardiovascular Academy Society, Turkey
Enrollment
2738
Locations
1
Primary Endpoint
Compliance of NOACs in Turkish Population
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
April 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Cardiovascular Academy Society, Turkey
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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