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

NCT07159399 | Enrolling By Invitation

• 2 other identifiers: 202404014RINCNHRI-EX114-11409PI
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

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).

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

Secondary Outcomes (2)

• Composite thromboembolic events

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

• Composite major bleeding events

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

Study Arms (2)

Patient education

EXPERIMENTAL

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

Behavioral: Pharmacist-led patient education

Usual care

PLACEBO COMPARATOR

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

Other: Usual Care

Interventions

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.

Patient education

Usual Care OTHER

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

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 8, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)