MEdication Counselling Models for Outpatient oRal antIcoaguLation

Anticoagulants; Circulating, Hemorrhagic Disorder Clinical Trial

— MEMORIAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290440
• Other study ID #: 28/NDGD-HDDD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Gia Dinh People Hospital
• Contact: Minh-Hoang Tran, PharmD, PhD, MPH
• Phone: +84933342279
• Email: tmhoang[@]ntt.edu.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants; Circulating, Hemorrhagic Disorder
• Hemorrhagic Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gia Dinh People Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	All-cause hospitalisation	Measured using medical records and self-reported/family-reported information	24 months after randomisation
Secondary	VTE-related hospitalisation	Measured using medical records and self-reported/family-reported information	24 months after randomisation
Secondary	Bleeding-related hospitalisation	Measured using medical records and self-reported/family-reported information	24 months after randomisation
Secondary	All-cause mortality	Measured using medical records and self-reported/family-reported information	24 months after randomisation
Secondary	VTE-related mortality	Measured using medical records and self-reported/family-reported information	24 months after randomisation
Secondary	Bleeding-related mortality	Measured using medical records and self-reported/family-reported information	24 months after randomisation