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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication reminder app + video call | Experimental | Patients can use medication reminder app and have video recall |
|
| Medication reminder app only | Placebo Comparator | Patients can only use medication reminder app and cannot have video recall |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| video call | Procedure | Conduct video training every two weeks emphasizing medication adherence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence by pill count | Medication adherence by pill count: both the value itself and the percentage of 100% achieved | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence by App. Calculation | Medication adherence by App. Calculation | From enrollment to the end of treatment at 8 weeks |
| Clinical composite end poin | Clinical composite end point: including composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minjae Yoon, MD | Contact | 82-10-6334-1917 | minjae1677@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | Gyeonggido | 13620 | South Korea |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Medication reminder app | Device | Medication reminder app will remind patients to take your medication. |
|
| From enrollment to the end of treatment at 8 weeks |
| App adherence by log trail | 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 | Change in adherence questionnaire scores from baseline to week 8 Rated on a scale of 1 to 5, with higher scores being better | From enrollment to the end of treatment at 8 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |