MEdication Counselling Models for Outpatient oRal antIcoaguLation (MEMORIAL)

Development of Medication Counselling Models for Outpatient Oral Anticoagulant-taking Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anticoagulants; Circulating, Hemorrhagic Disorder
• Intervention / Treatment: Other: Pharmacist-led counselling; Other: Telepharmacy-led counselling

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minh-Hoang Tran, PharmD, PhD, MPH; Phone Number: +84933342279; Email: tmhoang@ntt.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pharmacist-led counselling	Other: Pharmacist-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.
Experimental: Telepharmacy-led counselling	Other: Telepharmacy-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	Measured at month 1, 6, and 12 after randomisation

Collaborators and Investigators

• Sponsor: Gia Dinh People Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: mortality; medication adherence; venous thromboembolism; knowledge; counselling; oral anticoagulant; hospitalisation; distance counselling
• Additional Relevant MeSH Terms: Hematologic Diseases; Hemorrhagic Disorders
• Other Study ID Numbers: 28/NDGD-HDDD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No