NCT06903845

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

March 28, 2025

Last Update Submit

April 3, 2025

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationmobile applicationdigital healthmedication adherence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

Study Arms (2)

Medication reminder app + video call

EXPERIMENTAL

Patients can use medication reminder app and have video recall

Procedure: video callDevice: Medication reminder app

Medication reminder app only

PLACEBO COMPARATOR

Patients can only use medication reminder app and cannot have video recall

Device: Medication reminder app

Interventions

video callPROCEDURE

Conduct video training every two weeks emphasizing medication adherence.

Medication reminder app + video call
Medication reminder appDEVICE

Medication reminder app will remind patients to take your medication.

Medication reminder app + video callMedication reminder app only

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyeonggido, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationMedication Adherence

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Minjae Yoon, MD

CONTACT

82-10-6334-1917minjae1677@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 1, 2025

Study Start

March 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)