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

N/AEnrolling By InvitationNCT07159399

National Taiwan University400 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

400

Conditions

Atrial Fibrillation (AF)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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