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

NCT06187155 | Recruiting DMC

• 1 other identifier: 20230614MYFAHC_INR
• Study Type: interventional
• Target: 586
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

INR self-management; education level; warfarin; time in therapeutic range

Outcome Measures

Primary Outcomes (1)

• Time and proportion of INR in therapeutic range

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

  6 months

Secondary Outcomes (5)

• All-cause mortality

  6 months

• Thrombo-embolic events

  6 months

• Major bleeding

  6 months

• Minor bleeding

  6 months

• Frequency of testing

  6 months

Study Arms (2)

INR-self management

EXPERIMENTAL

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.

Other: INR self-management

Standard of care

NO INTERVENTION

Regular INR monitoring and seeking medical advice at Aswan Heart Centre

Interventions

INR self-management OTHER

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.

INR-self management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Magdi Yacoub Heart Foundation: collaborator

Study Sites (1)

Aswan Heart Centre

Aswān, Egypt

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Hosny, MD

  Aswan Heart Centre

  STUDY DIRECTOR

Central Study Contacts

Hossameldin Hussein, MSc

CONTACT

+201092565995; hossameldin_hussein@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Specialist of Adult Cardiology

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 2, 2024
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

EG (1)