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The goal of this clinical trial is to investigate whether telepharmacy-led counselling can improve medication adherence, knowledge, and hospitalisation/mortality compared with pharmacist-led counselling in adult outpatients taking oral anticoagulants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist-led counselling | Active Comparator |
| |
| Telepharmacy-led counselling | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telepharmacy-led counselling | Other | The counselling process will be delivered as follows: (1) researchers assist patients in signing up and using the telepharmacy application; (2) researchers send the counselling information from the telepharmacy application to the patient's account (the information will be provided as leaflets and 3-5-minute videos to improve the accessibility); (3) the integrated chatbot system forwards any additional questions or concerns of the patients to the counselling pharmacists; and (4) the pharmacists directly address the patient's questions or concerns through phone calls within the shortest possible timeframe. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence | Measured using Morisky-Green-Levine scale. The levels of adherence are: (1) high (0 point); (2) medium (1-2 points); and (3) low (3-4 points). | Measured at month 1, 6, and 12 after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of oral anticoagulants | Measured using Anticoagulant Knowledge Tool scale that was modified and validated on Vietnamese patients. This includes two sections: (1) general knowledge of oral anticoagulants (16 questions with a maximum score of 21) and (2) specific knowledge of vitamin K antagonists (5 questions with a maximum score of 8, only for patients using vitamin K antagonists). For multiple-choice questions, 1 correct answer earns 1 point, while for short-answer questions, 1 correct answer may result in 1-3 points, depending on the questions. The standardized score will be presented as percentage (based on the maximum score of 21 for direct-acting oral anticoagulant-taking patients or 29 for those using vitamin K antagonists), with the higher score indicating better knowledge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minh-Hoang Tran, PharmD, PhD, MPH | Contact | +84933342279 | tmhoang@ntt.edu.vn |
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| ID | Term |
|---|---|
| D006474 | Hemorrhagic Disorders |
| D055118 | Medication Adherence |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| Pharmacist-led counselling | Other | Pharmacists will counsel the patients on how to use their OAC. Each counselling section will take approximately 7-15 minutes, depending on the patient's questions or concerns. The counselling contents have already been compiled and validated by NDGD Hospital to ensure rationale and simplicity for every patient. Counselling pharmacists have received specialised training in drug information and patient communication so intervention delivery will be consistent across different pharmacists. |
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| Measured at month 1, 6, and 12 after randomisation |
| All-cause hospitalisation | Measured using medical records and self-reported/family-reported information | 24 months after randomisation |
| VTE-related hospitalisation | Measured using medical records and self-reported/family-reported information | 24 months after randomisation |
| Bleeding-related hospitalisation | Measured using medical records and self-reported/family-reported information | 24 months after randomisation |
| All-cause mortality | Measured using medical records and self-reported/family-reported information | 24 months after randomisation |
| VTE-related mortality | Measured using medical records and self-reported/family-reported information | 24 months after randomisation |
| Bleeding-related mortality | Measured using medical records and self-reported/family-reported information | 24 months after randomisation |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |