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Enrolling by Invitation

NCT Number: NCT07159399

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

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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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Pharmacist-led patient education

Behavioral

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.

Usual Care

Other

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

Primary outcomes

  1. Medication adherence

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

    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).

Secondary outcomes

  1. Composite thromboembolic events

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

    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 (%)

  2. Composite major bleeding events

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

    Incidence of major bleeding events, including intracranial hemorrhage (ICH), gastrointestinal bleeding (GIB), and other major bleeding requiring hospitalization.

    Unit of Measure: Percentage of participants (%)

Sponsors and collaborators

Lead sponsor

National Taiwan University

Other

Registry information

Official study title

Impact of a Pharmacist-Led Education Program on Medication Adherence and Treatment Effectiveness of Direct Oral Anticoagulants in Patients With Atrial Fibrillation: A Randomized Controlled Trial

Acronym: PharmAD-AF

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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