MEdication Counselling Models for Outpatient oRal antIcoaguLation

NCT ID: NCT06290440

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Anticoagulants; Circulating, Hemorrhagic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pharmacist-led counselling

Group Type ACTIVE_COMPARATOR

Pharmacist-led counselling

Intervention Type 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.

Telepharmacy-led counselling

Group Type EXPERIMENTAL

Telepharmacy-led counselling

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gia Dinh People Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Minh-Hoang Tran, PharmD, PhD, MPH

Role: CONTACT

+84933342279

Other Identifiers

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28/NDGD-HDDD

Identifier Type: -

Identifier Source: org_study_id

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