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Improvement of drug adherence to edoxaban using a smartphone application

Self-awareness of drug adherence to edoxaban using an automatic app. feedback system: a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004754
Enrollment
500
Registered
2020-02-20
Start date
2020-11-10
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : After the randomization, study subjects in intervention group should use a smartphone application that was invented for this study. They can download the application on the web. The subjects

Sponsors

Seoul National University Bundang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with atrial fibrillation with edoxaban treatment for stroke prevention 2. Age equal or greater than 19 years-old 3. Capable of use smart-phone application 4. Accepted for the study protocol and willing to participate the clinical study

Exclusion criteria

Exclusion criteria: 1. Creatinine clearance less than 15 mL/min/1.73m2 2. Patients with dual antiplatelet therapy 3. More than moderate mitral stenosis 4. Previous history of mitral valve replacement or mitral valve repair 5. Previous history of alcohol or drug abuse 6. Not suitable for the clinical trial enrollment by the judgement of investigator 7. History of previous enrollment of other clinical trial using investigational pharmaceutical product 8. Patient is not willing to participate the clinical study

Design outcomes

Primary

MeasureTime frame
Adherence by pill count ([The number of pills should be taken - Number of missed pills]/ total number of pills should be taken during the period);adequate medication adherence, which was defined as =95% of continuous medication adherence

Secondary

MeasureTime frame
Stroke;systemic embolic event;major bleeding requiring hospitalization or transfusion;clinical composite endpoints, including stroke, systemic embolic events, major bleeding requiring hospitalization or transfusion, and death

Countries

Korea, Republic of

Contacts

Public ContactJi Hyun Lee

Seoul National University Bundang Hospital

89family@hanmail.net+82-31-787-7083

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 12, 2026