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Enrolling by invitationNCT07159399PharmAD-AFUpdated Sep 8, 2025

A Pharmacist-Led Education Program to Improve Adherence to Direct Oral Anticoagulants in Patients With Atrial Fibrillation

An interventional study of Pharmacist-led patient education and Usual Care in Atrial Fibrillation (AF), sponsored by National Taiwan University. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by National Taiwan University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2025, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Atrial fibrillation (irregular heartbeat) increases the risk of stroke, and patients are commonly treated with direct oral anticoagulants (DOACs). However, when patients do not take these medications regularly, the drugs may not work effectively, increasing health risks.

In this study, called PharmAD-AF, specially trained pharmacists will meet with patients who have atrial fibrillation and are prescribed DOACs. They will offer personalized education and support to help patients take their medications as directed.

Researchers will compare groups of patients who receive this pharmacist-led education versus those who receive usual care. The main goals are to assess whether pharmacist support improves how consistently patients take their DOACs and how well the treatment prevents strokes while avoiding the side effects of DOAC therapy.

If successful, the study will demonstrate how pharmacist-led education can help patients stick to their treatment plan and reduce serious health risks, offering a practical way to improve heart-related care.

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Conditions studied

  • Atrial Fibrillation (AF)

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03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 400 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

National Taiwan University is the lead sponsor of 22 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years of age or older
  • have a confirmed diagnosis of AF
  • are expected to begin DOAC therapy for at least 3 months for stroke prevention

Exclusion criteria

Exclusion Criteria:

  • cannot understand DOAC-related education due to low literacy, language barriers, or cognitive impairment
  • have been on DOAC therapy for more than 6 months
  • using DOACs in off-label regimens
  • are pregnant or breastfeeding
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Patient education

    Patients in this arm will receive a comprehensive DOAC education from trained pharmacists.

    Behavioral: Pharmacist-led patient education

  • Placebo comparator
    Usual care

    Patients in this arm will receive only usual care, without pharmacists providing additional DOAC education materials.

    Other: Usual Care

Interventions

  • BehavioralPharmacist-led patient education

    Trained pharnacists will provide information on: (1) the indication and the reason of DOAC prescription, (2) the name and the appearance of the DOAC agent, (3) the dose, frequency, time of administration, (4) the mechanism of action, (5) management of missed doses, (6) potential side effects and self-monitoring, and (7) perioperative management. An education leaflet about DOACs will also be provided to improve patients' understanding about the use of DOACs.

  • OtherUsual Care

    Patients in the usual care group will receive only usual care, without pharmacists providing additional DOAC education materials.

06

What researchers measure

Primary outcomes

  1. Medication adherence

    Patients' adherence to DOACs will be assessed using the Adherence to Refills and Medications Scale (ARMS). The ARMS is a 12-item scale, including eight items on medication-taking adherence and four items on refill adherence. The total score ranges from 12 to 48, with higher scores indicating greater barriers to adherence. Unit of Measure: Score (points).

    Time frame: Medication adherence will be measured at 3 months and 6 months after the baseline visit.

Secondary outcomes

  1. Composite thromboembolic events

    Incidence of systemic thromboembolism, defined as occurrence of ischemic stroke (IS), transient ischemic attack (TIA), myocardial infarction (MI), coronary artery disease (CAD), peripheral artery disease (PAD), or venous thromboembolism (VTE). Unit of Measure: Percentage of participants (%)

    Time frame: Composite thromboembolic events will be measured at 1 year and 2 years after the baseline visit

  2. Composite major bleeding events

    Incidence of major bleeding events, including intracranial hemorrhage (ICH), gastrointestinal bleeding (GIB), and other major bleeding requiring hospitalization. Unit of Measure: Percentage of participants (%)

    Time frame: Composite bleeding events will be measured at 1 year and 2 years after the baseline visit

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Study locations

1 site
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References and documents

Publications

  • Liu SY, Huang YM, Lin SY, Wang CC. Pharmacist-Led Intervention to Enhance Direct Oral Anticoagulant Adherence and Treatment Outcomes in Atrial Fibrillation: A Pragmatic Clinical Trial. Patient Prefer Adherence. 2026 Jan 8;20:565777. doi: 10.2147/PPA.S565777. eCollection 2026. PubMed 41858640 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07159399
Lead sponsor
National Taiwan University
Responsible party
Chi-Chuan Wang (Associate Professor, National Taiwan University) — Principal investigator
First posted
Sep 8, 2025
Start date
Mar 5, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Sep 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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