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Enrolling by invitation NCT07159399

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

No phase Interventional Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacist-led patient education, Usual Care.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Behavioral Pharmacist-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.
  • Other Usual Care
    Patients in the usual care group will receive only usual care, without pharmacists providing additional DOAC education materials.

Primary outcome measures

  • Medication adherence [Time frame: Medication adherence will be measured at 3 months and 6 months after the baseline visit.]
Secondary outcome measures (2)
  • Composite thromboembolic events [Time frame: Composite thromboembolic events will be measured at 1 year and 2 years after the baseline visit]
  • Composite major bleeding events [Time frame: Composite bleeding events will be measured at 1 year and 2 years after the baseline visit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Health services research

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

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. PMID 41858640

Identifiers

NCT: NCT07159399 · 202404014RINC · NHRI-EX114-11409PI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗