Anticoagulants; Circulating, Hemorrhagic DisorderMEMORIALNCT06290440
MEdication Counselling Models for Outpatient oRal antIcoaguLation
A study testing Telepharmacy-led counselling and Pharmacist-led counselling in people with Anticoagulants; Circulating, Hemorrhagic Disorder, run by Gia Dinh People Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anticoagulants; Circulating, Hemorrhagic Disorder
- What is being tested?
- Telepharmacy-led counselling and Pharmacist-led counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old
- taking oral anticoagulants
- using smartphones that can access the telepharmacy application
- agreeing to participate
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Telepharmacy-led counselling, Pharmacist-led counselling
- Keywords
- oral anticoagulant, counselling, distance counselling, medication adherence, knowledge, hospitalisation, mortality, venous thromboembolism
- Medical subject headings
- Hemorrhagic Disorders, Medication Adherence, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telepharmacy-led counsellingOther
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 counsellingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-led counselling | Active comparator | Not described Receives: Other: Pharmacist-led counselling |
| Telepharmacy-led counselling | Experimental | Not described Receives: Other: Telepharmacy-led counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at month 1, 6, and 12 after randomisation
Secondary outcomes (7)
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: Measured at month 1, 6, and 12 after randomisation
All-cause hospitalisation
Measured using medical records and self-reported/family-reported information
Measured: 24 months after randomisation
VTE-related hospitalisation
Measured using medical records and self-reported/family-reported information
Measured: 24 months after randomisation
Bleeding-related hospitalisation
Measured using medical records and self-reported/family-reported information
Measured: 24 months after randomisation
All-cause mortality
Measured using medical records and self-reported/family-reported information
Measured: 24 months after randomisation
VTE-related mortality
Measured using medical records and self-reported/family-reported information
Measured: 24 months after randomisation
Bleeding-related mortality
Measured using medical records and self-reported/family-reported information
Measured: 24 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulants; Circulating, Hemorrhagic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gia Dinh People Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290440
- Sponsor's protocol ID
- 28/NDGD-HDDD
- Acronym
- MEMORIAL
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Medication Counselling Models for Outpatient Oral Anticoagulant-taking Patients
- ClinicalTrials.gov ID
- NCT06290440
- Acronym / sponsor ID
- MEMORIAL / 28/NDGD-HDDD
- Keywords
- oral anticoagulant, counselling, distance counselling, medication adherence, knowledge, hospitalisation, mortality, venous thromboembolism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Gia Dinh People HospitalUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-led counselling | Active comparator | Other: Pharmacist-led counselling |
| Telepharmacy-led counselling | Experimental | Other: Telepharmacy-led counselling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years old
- taking oral anticoagulants
- using smartphones that can access the telepharmacy application
- agreeing to participate
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telepharmacy-led counsellingThe 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. | Other | Telepharmacy-led counselling |
| Pharmacist-led counsellingPharmacists 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. | Other | Pharmacist-led counselling |
Primary outcome
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).
7 secondary outcomes
Knowledge of oral anticoagulants
Time frame: Measured at month 1, 6, and 12 after randomisation
All-cause hospitalisation
Time frame: 24 months after randomisation
VTE-related hospitalisation
Time frame: 24 months after randomisation
Bleeding-related hospitalisation
Time frame: 24 months after randomisation
All-cause mortality
Time frame: 24 months after randomisation
VTE-related mortality
Time frame: 24 months after randomisation
Bleeding-related mortality
Time frame: 24 months after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Telepharmacy-led counselling and Pharmacist-led counselling in people with Anticoagulants; Circulating, Hemorrhagic Disorder, run by Gia Dinh People Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minh-Hoang Tran, PharmD, PhD, MPH (+84933342279, tmhoang@ntt.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: Measured at month 1, 6, and 12 after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.