APIXABAN App Study

Официальное название

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)

Обзор

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.

Вмешательства

• Процедура video call
  Conduct video training every two weeks emphasizing medication adherence.
• Устройство Medication reminder app
  Medication reminder app will remind patients to take your medication.

Первичные конечные точки

• Medication adherence by pill count [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (4)

• Medication adherence by App. Calculation [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Clinical composite end poin [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• App adherence by log trail [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in adherence questionnaire scores from baseline to week 8 [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Seoul National University Bundang Hospital — Seongnam

Идентификаторы

NCT: NCT06903845 · APIXABAN app

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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