Atrial Fibrillation (AF)PharmAD-AFNCT07159399
A Pharmacist-Led Education Program to Improve Adherence to Direct Oral Anticoagulants in Patients With Atrial Fibrillation
A study testing Pharmacist-led patient education in people with Atrial Fibrillation (AF), run by National Taiwan University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Pharmacist-led patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2025to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read more
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)
- Being tested
- Pharmacist-led patient education, Usual Care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led patient educationBehavioural
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 CareOther
Patients in the usual care group will receive only usual care, without pharmacists providing additional DOAC education materials.
| Study group | Role | What they receive |
|---|---|---|
| Patient education | Experimental | Patients in this arm will receive a comprehensive DOAC education from trained pharmacists. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Medication adherence will be measured at 3 months and 6 months after the baseline visit.
Secondary outcomes (2)
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 (%)
Measured: Composite thromboembolic events will be measured at 1 year and 2 years after the baseline visit
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 (%)
Measured: Composite bleeding events will be measured at 1 year and 2 years after the baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start5 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Chuan Wang, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159399
- Sponsor's protocol ID
- 202404014RINC
- Other IDs
- NHRI-EX114-11409PI
- Acronym
- PharmAD-AF
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41858640
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07159399
- Acronym / sponsor ID
- PharmAD-AF / 202404014RINC
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient education | Experimental | Behavioral: Pharmacist-led patient educationPatients in this arm will receive a comprehensive DOAC education from trained pharmacists. |
| Usual care | Placebo comparator | Other: Usual CarePatients in this arm will receive only usual care, without pharmacists providing additional DOAC education materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-led patient educationTrained 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. | Behavioural | Patient education |
| Usual CarePatients in the usual care group will receive only usual care, without pharmacists providing additional DOAC education materials. | Other | Usual care |
Primary outcome
Medication adherence
Time frame: Medication adherence will be measured at 3 months and 6 months after the baseline visit.
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).
2 secondary outcomes
Composite thromboembolic events
Time frame: Composite thromboembolic events will be measured at 1 year and 2 years after the baseline visit
Composite major bleeding events
Time frame: Composite bleeding events will be measured at 1 year and 2 years after the baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 41858640Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led patient education in people with Atrial Fibrillation (AF), run by National Taiwan University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: Medication adherence will be measured at 3 months and 6 months after the baseline visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07159399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.