RecruitingNot ApplicableNCT06903845

APIXABAN App Study

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)


Sponsor

Dong-Ju Choi

Enrollment

40 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 19 Years

Inclusion Criteria13

  • 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

Exclusion Criteria8

  • 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

Interventions

PROCEDUREvideo call

Conduct video training every two weeks emphasizing medication adherence.

DEVICEMedication reminder app

Medication reminder app will remind patients to take your medication.


Locations(1)

Seoul National University Bundang Hospital

Seongnam, Gyeonggido, South Korea

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NCT06903845


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