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| ID | Type | Description | Link |
|---|---|---|---|
| NHRI-EX114-11409PI | Other Grant/Funding Number | National Health Research Institutes |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient education | Experimental | Patients in this arm will receive a comprehensive DOAC education from trained pharmacists. |
|
| Usual care | Placebo Comparator | Patients in this arm will receive only usual care, without pharmacists providing additional DOAC education materials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%) | Composite thromboembolic events will be measured at 1 year and 2 years after the baseline visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41858640 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2024 | Aug 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2024 | Sep 3, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Usual Care | Other | Patients in the usual care group will receive only usual care, without pharmacists providing additional DOAC education materials. |
|
| 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 (%) | Composite bleeding events will be measured at 1 year and 2 years after the baseline visit |
| D013568 |
| Pathological Conditions, Signs and Symptoms |