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

NCT ID: NCT07159399

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-05

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Patient education

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

Group Type EXPERIMENTAL

Pharmacist-led patient education

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University

OTHER

Sponsor Role lead

Responsible Party

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Chi-Chuan Wang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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NHRI-EX114-11409PI

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202404014RINC

Identifier Type: -

Identifier Source: org_study_id

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