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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Другое Usual Care
  Patients in the usual care group will receive only usual care, without pharmacists providing additional DOAC education materials.

Первичные конечные точки

• Medication adherence [Срок оценки: Medication adherence will be measured at 3 months and 6 months after the baseline visit.]

Вторичные конечные точки (2)

• Composite thromboembolic events [Срок оценки: Composite thromboembolic events will be measured at 1 year and 2 years after the baseline visit]
• Composite major bleeding events [Срок оценки: Composite bleeding events will be measured at 1 year and 2 years after the baseline visit]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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