Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000459426
Ethics application status
Approved
Date submitted
9/01/2025
Date registered
15/05/2025
Date last updated
15/05/2025
Date data sharing statement initially provided
15/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nurse-led Warfarin Therapy Guide for Improving Patient Safety After Mechanical Valve Replacement - A Randomized Control Trial
Scientific title
Nurse-led Warfarin Therapy Guide for Improving Patient Safety After Mechanical Valve Replacement - A Randomized Control Trial
Secondary ID [1] 312831 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post operative heart valve replacement 334939 0
Condition category
Condition code
Cardiovascular 331479 331479 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure


Physical or Informational Materials Used
• Educational Booklets:
A Warfarin Therapy Guide for Patient Safety after Mechanical Valve Replacement will be used. This guide includes information on warfarin therapy, medication adherence, and International Normalized Ratio (INR) stability.
This guide is a study-specific resource, developed for the purpose of this intervention to ensure consistency and relevance to the patient group.

Procedures, Activities, and Processes Used
1. Initial Assessment and Patient Enrollment
o Baseline International Normalized Ratio (INR) levels, medical history, and patient readiness for anticoagulation therapy will be assessed prior to enrollment.
2. Individualized Patient Education
o A 30-minute one-on-one education session will be delivered by trained nurses using the study-specific Warfarin Therapy Guide. This session will occur prior to the initiation of warfarin therapy.
3. Weekly INR Testing
o INR testing will be conducted weekly, with immediate review of results and adjustments to warfarin doses as necessary.
4. Dose Adjustment
o Dose modifications will be made by nurses, following standardized, evidence-based protocols approved by supervising physicians.
5. Proactive Follow-Ups
o Weekly INR check-ins will be performed either in-person or virtually to monitor patient progress and medication adherence.

Who Will Deliver the Intervention?
• The intervention will be delivered by trained nursing staff who are part of the study team. The nurses will be responsible for patient education, INR monitoring, and warfarin dose adjustment under physician oversight.

Training for Nurses
• All participating nurses will receive two hours of face-to-face training on the use of the Warfarin Therapy Guide, the INR monitoring protocol, and the dose adjustment checklist.
• Training will be delivered by a clinical pharmacist and a supervising cardiologist involved in the study.
• This training will occur three weeks prior to the enrollment of the first participant.


Mode of Delivery
• The intervention will be delivered via a combination of in-person and virtual formats:
o In-person INR testing and education sessions at the Pakistan Institute of Cardiology
o Telephonic and video call consultations based on patient preference and availability

Frequency and Duration
• Duration: 6 months per patient, starting immediately post mechanical valve replacement
• Frequency:
o Weekly sessions for the first 4 months
o Bi-weekly or monthly follow-ups for the final 2 months based on INR stability

Location/Setting
• All in-person activities will take place at the Outpatient Department of Pakistan Institute of Cardiology.

Strategies to Assess or Monitor Adherence and Fidelity
1. Patient Logs
o Patients will maintain daily logs to record warfarin doses, missed doses, and any symptoms.
2. INR Trends
o Ongoing monitoring of INR levels to detect patterns in adherence and dose adjustments.
3. Protocol Checklists
o Nurses will use standardized checklists during dose adjustment to ensure protocol adherence.
4. Random Audits
o Regular audits of educational materials, patient logs, and adherence documentation will be conducted to ensure consistency with the intervention protocol.
Intervention code [1] 329376 0
Prevention
Comparator / control treatment
Participants in the control group will receive routine post-operative care as per hospital guidelines following mechanical valve replacement. This includes:

Initiation of Warfarin Therapy as prescribed by the treating physician

INR (International Normalized Ratio) Monitoring through regular outpatient visits at intervals determined by clinical need

General Verbal Instructions regarding warfarin use, dietary considerations, and potential side effects, typically provided during hospital discharge

Dose Adjustments managed by physicians based on INR results

No structured education sessions, follow-up calls, or standardized educational materials will be provided beyond usual care
Control group
Active

Outcomes
Primary outcome [1] 340493 0
To evaluate the effects of implementing a Warfarin Therapy Guide on the incidence of major bleeding and thromboembolic events in patients following mechanical valve replacement. This will be assessed as a composite outcome
Timepoint [1] 340493 0
8 week after completed of Intervention
Secondary outcome [1] 444252 0
Time in Therapeutic Range (TTR): The proportion of time the patient’s INR remains within the target therapeutic range (e.g., 2.5–3.5) during the 6-month intervention period.
Timepoint [1] 444252 0
8 week after completed of intervention

Eligibility
Key inclusion criteria
1. Adult patients (18+ years) who have undergone mechanical valve replacement.
2. Patients who have been on Warfarin therapy form day first to at least three months.
3. Patients capable of understanding the Warfarin Therapy guide language in Urdu and English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with cognitive impairments that preclude understanding of the education guide.
2. Patients with terminal illnesses or other conditions that severely limit life expectancy.
3. Patients not fluent in the language used in the education guide.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer softwar
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 26601 0
Pakistan
State/province [1] 26601 0
Lahore/Punjab

Funding & Sponsors
Funding source category [1] 317271 0
Self funded/Unfunded
Name [1] 317271 0
Aman khalid
Country [1] 317271 0
Primary sponsor type
Individual
Name
Aman Khalid - The University of Lahore
Address
Country
Pakistan
Secondary sponsor category [1] 321187 0
None
Name [1] 321187 0
Address [1] 321187 0
Country [1] 321187 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316009 0
Research Ethical committee of university of lahore
Ethics committee address [1] 316009 0
Ethics committee country [1] 316009 0
Pakistan
Date submitted for ethics approval [1] 316009 0
28/10/2024
Approval date [1] 316009 0
05/12/2024
Ethics approval number [1] 316009 0
REC-UOL-/478/24

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136486 0
Mr aman khalid
Address 136486 0
Lahore School of Nursing, The University of Lahore, 1-Km Defence Road, near Bhupatian Chowk, Lahore, Punjab, postcode 54590
Country 136486 0
Pakistan
Phone 136486 0
+923418712490
Fax 136486 0
Email 136486 0
[email protected]
Contact person for public queries
Name 136487 0
aman khalid
Address 136487 0
Lahore School of Nursing, The University of Lahore, 1-Km Defence Road, near Bhupatian Chowk, Lahore, Punjab, postcode 54590
Country 136487 0
Pakistan
Phone 136487 0
+923418712490
Fax 136487 0
Email 136487 0
[email protected]
Contact person for scientific queries
Name 136488 0
aman khalid
Address 136488 0
Lahore School of Nursing, The University of Lahore, 1-Km Defence Road, near Bhupatian Chowk, Lahore, Punjab, postcode 54590
Country 136488 0
Pakistan
Phone 136488 0
+923418712490
Fax 136488 0
Email 136488 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24712Ethical approval    RCE letter.pdf
24713Other    supervisor letter.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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