MEdication Counselling Models for Outpatient oRal antIcoaguLation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGia Dinh People Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥18 years old
taking oral anticoagulants
using smartphones that can access the telepharmacy application
agreeing to participate
Disqualifiers
pregnancy or lactation
having cancer
having immunodeficiency disorders or using immunosuppressants
renal impairment (creatinine clearance <30 mL/min)
Trial design
Design model
Parallel
Treatments tested in this trial
Telepharmacy-led counselling
Other interventionThe 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.
Pharmacist-led counselling
Other interventionPharmacists 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.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Pharmacist-led counsellingActive comparator 1 intervention
Group B: Telepharmacy-led counsellingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Measured at month 1, 6, and 12 after randomisationSecondary outcomes
1
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.
Time frame
Measured at month 1, 6, and 12 after randomisation2
All-cause hospitalisation
Measured using medical records and self-reported/family-reported information
Time frame
24 months after randomisation3
VTE-related hospitalisation
Measured using medical records and self-reported/family-reported information
Time frame
24 months after randomisation4
Bleeding-related hospitalisation
Measured using medical records and self-reported/family-reported information
Time frame
24 months after randomisationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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