Actively Recruiting
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
Eligibility Criteria
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.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Aswan Heart Centre
Aswān, Egypt
Actively Recruiting
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here