Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06187155

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

Led by Cairo University · Updated on 2024-09-05

586

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Cairo University

Lead Sponsor

M

Magdi Yacoub Heart Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients above 18 years who are indicated for long term VKA and has been on VKA for more than 6 months.
Not Eligible

You will not qualify if you...

  • Refusal to join the study.
  • History of prior life-threatening bleeding or thrombo-embolic events.
  • Illiterate patients with no caregivers living at the same home.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Aswan Heart Centre

Aswān, Egypt

Actively Recruiting

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Research Team

H

Hossameldin Hussein, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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