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Impact of Education Level on Clinical Outcomes in Self-INR Managed Patients

NCT06187155 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 586

Last updated 2024-09-05

No results posted yet for this study

Summary

Oral anticoagulation (OAC) is indicated in a wide variety of clinical conditions including atrial fibrillation (AF), mechanical valve prosthesis (MVP), deep vein thrombosis and pulmonary embolism. Although direct OAC has replaced vitamin K antagonists (VKA) in non-valvular AF due to lower bleeding risk, it's still recommended to use VKA specifically in cases of valvular AF, MVP and anti-phospholipid syndrome.

VKA has a narrow therapeutic range and multiple drug interactions causing unpredicted pharmacodynamics. This requires regular monitoring of the international normalized ratio (INR) level to ensure it's in the target therapeutic range and prevent extreme values that may result in thrombo-embolic events or sometimes fatal bleeding.

Self-INR monitoring and management have emerged recently as a safe cost-effective alternative to standard management, with evidence of tighter control of INR, reduction of thrombo-embolic events, and improving treatment-related quality of life. However, there are no specific criteria for patient selection. Whether the level of education and other social factors would affect the outcomes of self-management is still not clear.

Owing to the wide geographical area served by Aswan Heart Center, many patients have to cover long distances to follow up their INR and seek medical advice regarding adequate dose modification. This may result in reluctance and non-compliance to clinic visits and INR testing. Proper education, training and providing an alternative near place to measure the INR and self-adjust warfarin dose is expected to improve patient adherence and compliance.

Conditions

  • Atrial Fibrillation and Flutter
  • Mechanical Mitral Valve Prosthesis

Interventions

OTHER

INR self-management

will receive full education class of minimum one-hour time and training about how to interpret INR levels independently and adjust their medication dose according to a pre-determined dose-INR schedule.

Sponsors & Collaborators

  • Magdi Yacoub Heart Foundation

    collaborator OTHER

  • Cairo University

    lead OTHER

Principal Investigators

  • Mohamed Hosny, MD · Aswan Heart Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06187155 on ClinicalTrials.gov