APIXABAN App Study

April 3, 2025 updated by: Dong-Ju Choi

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggido
      • Seongnam, Gyeonggido, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medication reminder app + video call
Patients can use medication reminder app and have video recall
Procedure: video call
Conduct video training every two weeks emphasizing medication adherence.
Device: Medication reminder app
Medication reminder app will remind patients to take your medication.
Placebo Comparator: Medication reminder app only
Patients can only use medication reminder app and cannot have video recall
Device: Medication reminder app
Medication reminder app will remind patients to take your medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence by App. Calculation
Time Frame: From enrollment to the end of treatment at 8 weeks
Medication adherence by App. Calculation
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
Clinical composite end point: including composites of stroke, systemic embolic event, major bleeding requiring hospitalization or transfusion, or death
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
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
Time Frame: 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
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-Ju Choi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APIXABAN app

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on video call

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe