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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Medication adherence by pill count
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
结局指标
主要结局
Medication adherence by pill count
时间窗: From enrollment to the end of treatment at 8 weeks
Medication adherence by pill count: both the value itself and the percentage of 100% achieved
次要结局
- Medication adherence by App. Calculation(From enrollment to the end of treatment at 8 weeks)
- Clinical composite end poin(From enrollment to the end of treatment at 8 weeks)
- App adherence by log trail(From enrollment to the end of treatment at 8 weeks)
- Change in adherence questionnaire scores from baseline to week 8(From enrollment to the end of treatment at 8 weeks)
研究者
Dong-Ju Choi
Professor
Seoul National University Bundang Hospital