Atrial FibrillationNCT06903845
APIXABAN App Study
A study testing video call and Medication reminder app in people with Atrial Fibrillation, run by Dong-Ju Choi at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- video call and Medication reminder app
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- Heart failure
- Hypertension
- Coronary artery disease
- Peripheral arterial disease
- Diabetes mellitus
- Stroke
- 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 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, 13620
Minjae Yoon, MD, 82-10-6334-1917, minjae1677@gmail.com
About this study
Official title: 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)
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.
Read more
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.
- Conditions
- Atrial Fibrillation
- Being tested
- video call, Medication reminder app
- Keywords
- atrial fibrillation, mobile application, digital health, medication adherence
- Medical subject headings
- Atrial Fibrillation, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video callProcedure or surgery
Conduct video training every two weeks emphasizing medication adherence.
Medication reminder appDevice
Medication reminder app will remind patients to take your medication.
| Study group | Role | What they receive |
|---|---|---|
| Medication reminder app + video call | Experimental | Patients can use medication reminder app and have video recall Receives: Procedure: video call; Device: Medication reminder app |
| Medication reminder app only | Placebo comparator | Patients can only use medication reminder app and cannot have video recall Receives: Device: Medication reminder app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence by pill count
Medication adherence by pill count: both the value itself and the percentage of 100% achieved
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (4)
Medication adherence by App. Calculation
Medication adherence by App. Calculation
Measured: 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
Measured: From enrollment to the end of treatment at 8 weeks
App adherence by log trail
App adherence by log trail
Measured: 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
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-Ju Choi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong-Ju Choi, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903845
- Sponsor's protocol ID
- APIXABAN app
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06903845
- Acronym / sponsor ID
- APIXABAN app
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, mobile application, digital health, medication adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dong-Ju ChoiUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication reminder app + video call | Experimental | Procedure: video call, Device: Medication reminder appPatients can use medication reminder app and have video recall |
| Medication reminder app only | Placebo comparator | Device: Medication reminder appPatients can only use medication reminder app and cannot have video recall |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video callConduct video training every two weeks emphasizing medication adherence. | Procedure or surgery | Medication reminder app + video call |
| Medication reminder appMedication reminder app will remind patients to take your medication. | Device | Medication reminder app + video call, Medication reminder app only |
Primary outcome
Medication adherence by pill count
Time frame: 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
4 secondary outcomes
Medication adherence by App. Calculation
Time frame: From enrollment to the end of treatment at 8 weeks
Clinical composite end poin
Time frame: From enrollment to the end of treatment at 8 weeks
App adherence by log trail
Time frame: From enrollment to the end of treatment at 8 weeks
Change in adherence questionnaire scores from baseline to week 8
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video call and Medication reminder app in people with Atrial Fibrillation, run by Dong-Ju Choi at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minjae Yoon, MD (82-10-6334-1917, minjae1677@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence by pill count (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.