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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • INR self-management

    Other intervention

    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.

Treatment groups

586 Participants
are divided into 2 treatment groups
Group A: INR-self managementExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time and proportion of INR in therapeutic range

Time in therapeutic range and percentage of test results in therapeutic range

Time frame
6 months

Secondary outcomes

1

All-cause mortality

Death from any cause

Time frame
6 months
2

Thrombo-embolic events

Stroke, valve thrombosis or peripheral embolism

Time frame
6 months
3

Major bleeding

Overt bleeding that requires medical intervention or hospitalization

Time frame
6 months
4

Minor bleeding

Self-controlled bleeding that doesn't need seeking medical advice

Time frame
6 months

Other outcomes

Sponsors and contacts

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Cairo University

Lead sponsor

Magdi Yacoub Heart Foundation

Sponsor institution

Magdi Yacoub Heart Foundation

Collaborator