MEdication Counselling Models for Outpatient oRal antIcoaguLation

NCT06290440 | Not Yet Recruiting

• 1 other identifier: 28/NDGD-HDDD
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anticoagulants; Circulating, Hemorrhagic Disorder

Keywords

oral anticoagulant; counselling; distance counselling; medication adherence; knowledge; hospitalisation; mortality; venous thromboembolism

Outcome Measures

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).

  Measured at month 1, 6, and 12 after randomisation

Secondary Outcomes (7)

• Knowledge of oral anticoagulants

  Measured at month 1, 6, and 12 after randomisation

• All-cause hospitalisation

  24 months after randomisation

• VTE-related hospitalisation

  24 months after randomisation

• Bleeding-related hospitalisation

  24 months after randomisation

• All-cause mortality

  24 months after randomisation

Study Arms (2)

Pharmacist-led counselling

ACTIVE COMPARATOR

Other: Pharmacist-led counselling

Telepharmacy-led counselling

EXPERIMENTAL

Other: Telepharmacy-led counselling

Interventions

Telepharmacy-led counselling OTHER

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.

Telepharmacy-led counselling

Pharmacist-led counselling OTHER

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.

Pharmacist-led counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• taking oral anticoagulants
• using smartphones that can access the telepharmacy application
• agreeing to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Gia Dinh People Hospital: lead

MeSH Terms

Conditions

Hemorrhagic Disorders; Medication Adherence; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Minh-Hoang Tran, PharmD, PhD, MPH

CONTACT

+84933342279; tmhoang@ntt.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03