Anticoagulants; Circulating, Hemorrhagic Disorder
Conditions
Keywords
oral anticoagulant, counselling, distance counselling, medication adherence, knowledge, hospitalisation, mortality, venous thromboembolism
Brief summary
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.
Interventions
OTHERTelepharmacy-led counselling
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.
OTHERPharmacist-led counselling
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.
Sponsors
Gia Dinh People Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥18 years old * taking oral anticoagulants * using smartphones that can access the telepharmacy application * agreeing to participate
Exclusion criteria
* pregnancy or lactation * having cancer * having immunodeficiency disorders or using immunosuppressants * renal impairment (creatinine clearance \<30 mL/min) * hepatic impairment (Child-Pugh B or C cirrhosis) * heart failure (class IV, New York Heart Association) * history of myocardial infarction or stroke within the latest 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence | Measured at month 1, 6, and 12 after randomisation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause hospitalisation | 24 months after randomisation | Measured using medical records and self-reported/family-reported information |
| VTE-related hospitalisation | 24 months after randomisation | Measured using medical records and self-reported/family-reported information |
| Bleeding-related hospitalisation | 24 months after randomisation | Measured using medical records and self-reported/family-reported information |
| Knowledge of oral anticoagulants | Measured at month 1, 6, and 12 after randomisation | 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. |
| VTE-related mortality | 24 months after randomisation | Measured using medical records and self-reported/family-reported information |
| Bleeding-related mortality | 24 months after randomisation | Measured using medical records and self-reported/family-reported information |
| All-cause mortality | 24 months after randomisation | Measured using medical records and self-reported/family-reported information |
Contacts
Primary ContactMinh-Hoang Tran, PharmD, PhD, MPH
Outcome results
None listed