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NCT Number: NCT06290440

MEdication Counselling Models for Outpatient oRal antIcoaguLation

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.

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Key information

Conditions

Anticoagulants; Circulating, Hemorrhagic Disorder Behavior Cardiovascular Diseases Embolism and Thrombosis Health Behavior Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Medication Adherence Patient Acceptance of Health Care Patient Compliance Thromboembolism Treatment Adherence and Compliance Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Medication adherence

    Time frame: 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 outcomes

  1. Knowledge of oral anticoagulants

    Time frame: 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.

  2. All-cause hospitalisation

    Time frame: 24 months after randomisation

    Measured using medical records and self-reported/family-reported information

  3. VTE-related hospitalisation

    Time frame: 24 months after randomisation

    Measured using medical records and self-reported/family-reported information

  4. Bleeding-related hospitalisation

    Time frame: 24 months after randomisation

    Measured using medical records and self-reported/family-reported information

  5. All-cause mortality

    Time frame: 24 months after randomisation

    Measured using medical records and self-reported/family-reported information

  6. VTE-related mortality

    Time frame: 24 months after randomisation

    Measured using medical records and self-reported/family-reported information

  7. Bleeding-related mortality

    Time frame: 24 months after randomisation

    Measured using medical records and self-reported/family-reported information

Study contacts

Contact information is provided by the study sponsor or research team.

Minh-Hoang Tran, PharmD, PhD, MPH

CONTACT

[email protected]

+84933342279

Sponsors and collaborators

Lead sponsor

Gia Dinh People Hospital

Other

Registry information

Official study title

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

Acronym: MEMORIAL

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 4, 2024
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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