MEdication Counselling Models for Outpatient oRal antIcoaguLation

Not Applicable

Not yet recruiting

• Conditions: Anticoagulants; Circulating, Hemorrhagic Disorder
• Interventions: Other: Pharmacist-led counselling; Other: Telepharmacy-led counselling

• Registration Number: NCT06290440
• Lead Sponsor: Gia Dinh People Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-06
• Study Start: 2024-06
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist-led counselling	Pharmacist-led counselling	-
Telepharmacy-led counselling	Telepharmacy-led counselling	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
All-cause hospitalisation	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
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
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