APIXABAN App Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: video call, Medication reminder app.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of App. for Medication-check and Video-call Guided Education on APIXABAN Adherence in Patients of Atrial Fibrillation With Cardiac Disease: Randomised Control Pilot Study(APIXABAN Study)
Overview
The aim of this clinical trial is to evaluate whether the medication reminder app and video call can improve medication adherence to apixaban in patients with AF and comorbidities. Patients with AF and comorbid heart disease taking apixaban who meet the inclusion criteria will be randomised 1:1 to a treatment arm using a medication reminder app and bi-weekly video education and a control arm using the medication reminder app alone to compare medication adherence. Patients in both groups will use the medication app, but only the treatment group will receive additional education and feedback via video call every two weeks to reinforce the use of the medication app and medication reminders with video education. The study aims to assess the change in adherence between the two groups at week 8.
Interventions
- Procedure video call
Conduct video training every two weeks emphasizing medication adherence. - Device Medication reminder app
Medication reminder app will remind patients to take your medication.
Primary outcome measures
- Medication adherence by pill count [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (4)
- Medication adherence by App. Calculation [Time frame: From enrollment to the end of treatment at 8 weeks]
- Clinical composite end poin [Time frame: From enrollment to the end of treatment at 8 weeks]
- App adherence by log trail [Time frame: From enrollment to the end of treatment at 8 weeks]
- Change in adherence questionnaire scores from baseline to week 8 [Time frame: From enrollment to the end of treatment at 8 weeks]
Eligibility criteria
Participants must meet all of the following criteria:
Adults aged 19 years or older with a diagnosis of atrial fibrillation (AF)
Presence of at least one of the following cardiovascular or metabolic comorbidities:
A. Heart failure
B. Hypertension
C. Coronary artery disease
D. Peripheral arterial disease
E. Diabetes mellitus
F. Stroke
G. Other cardiac diseases requiring treatment
Currently taking or planning to initiate oral anticoagulation therapy with apixaban
Able to use a smartphone with an Android operating system
Voluntarily provided written informed consent to participate in the clinical trial after being adequately informed of its purpose, procedures, and potential risks
2\. Exclusion Criteria
Participants will be excluded if any of the following conditions apply:
Creatinine clearance (CCr) < 15 mL/min
Presence of moderate to severe mitral stenosis
History of mitral valve repair or replacement
Clinically significant history of alcohol or substance abuse
Deemed by the investigator to be legally or psychologically unsuitable for participation in the clinical trial
Participation in another clinical trial involving investigational drugs within 4 weeks prior to screening
Declines or is unwilling to provide informed consent for participation in this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Bundang Hospital — Seongnam
Identifiers
NCT: NCT06903845 · APIXABAN app