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

N

National Taiwan University

Status

Invitation-only

Conditions

Atrial Fibrillation (AF)

Treatments

Other: Usual Care
Behavioral: Pharmacist-led patient education

Study type

Interventional

Funder types

Other

Identifiers

NCT07159399
202404014RINC
NHRI-EX114-11409PI (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

400 participants in 2 patient groups, including a placebo group

Patient education
Experimental group
Description:
Patients in this arm will receive a comprehensive DOAC education from trained pharmacists.
Treatment:
Behavioral: Pharmacist-led patient education
Usual care
Placebo Comparator group
Description:
Patients in this arm will receive only usual care, without pharmacists providing additional DOAC education materials.
Treatment:
Other: Usual Care

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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