Adherence to New Oral Anticoagulation Therapy in Turkey

NCT02480920 | Completed Results

• 1 other identifier: NOAC-TR
• Study Type: observational
• Target: 2,738
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation Drug Adherence; New Oral Anticoagulants; Drug Adherence

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatients using a NOAC for at least 3 months duration, with a primary diagnosis of new-onset, non-valvular atrial fibrillation

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cardiovascular Academy Society, Turkey: lead

Study Sites (1)

Volkan Emren

Afyonkarahisar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial Fibrillation; Medication Adherence

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Volkan Emren
• Organization: Department of Cardiology, Afyonkarahisar State Hospital, Afyonkarahisar, Turkey

vemren@hotmail.com

Study Officials

• Volkan Emren, MD

  Cardiovascular Academy Society, İzmir, Turkey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 25, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 9, 2019
• Results First Posted: January 31, 2019

Record last verified: 2019-04

Locations

TU (1)