Impact of Education Level on Clinical Outcomes in Self-INR Managed Patients on Longterm Warfarin: a Single-center Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients above 18 years who are indicated for long term VKA and has been on VKA for more than 6 months.

Locations
Other Locations
Egypt
Aswan Heart Centre
RECRUITING
Aswān
Contact Information
Primary
Hossameldin Hussein, MSc
hossameldin_hussein@kasralainy.edu.eg
+201092565995
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 586
Treatments
Experimental: INR-self management
The participants will be responsible to monitor their INR regularly and adjust the warfarin dose by themselves accordingly, without seeking medical advice from medical personnel for 6 months.~All participants will receive full education class of minimum one-hour time and training about how to interpret INR levels and adjust their medication dose according to a pre-determined dose-INR schedule.
No_intervention: Standard of care
Regular INR monitoring and seeking medical advice at Aswan Heart Centre
Sponsors
Leads: Cairo University
Collaborators: Magdi Yacoub Heart Foundation

This content was sourced from clinicaltrials.gov

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