Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, mobile application, digital health, medication adherence
Brief 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.
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.
Sponsors
Dong-Ju Choi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence by pill count | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence by App. Calculation | From enrollment to the end of treatment at 8 weeks | Medication adherence by App. Calculation |
| Clinical composite end poin | From enrollment to the end of treatment at 8 weeks | Clinical composite end point: including composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death |
| App adherence by log trail | From enrollment to the end of treatment at 8 weeks | App adherence by log trail |
| Change in adherence questionnaire scores from baseline to week 8 | From enrollment to the end of treatment at 8 weeks | Change in adherence questionnaire scores from baseline to week 8 Rated on a scale of 1 to 5, with higher scores being better |
Countries
South Korea
Contacts
Primary ContactMinjae Yoon, MD
Outcome results
None listed