Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD

NCT04136379 | Completed

• 1 other identifier: 18/0081
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Summary: Congenital heart disease (CHD) is the most prevalent form of birth defect with a global rate of 1.35 million newborns born with CHD annually. Patients with CHD have an increased risk of cerebrovascular accident (CVA) compared to age-matched control populations. Anticoagulation with warfarin is the mainstay of antithrombotic treatment in these patients and requires frequent monitoring of the International Normalized Ratio (INR). The CoaguChek monitor is a point of care device that enables patients to self-monitor and manage their INR without the need to attend a warfarin clinic. The aim of this study is to compare the efficacy and outcomes of standard clinic management and home management of INR in patients with CHD. Analysis of time in therapeutic range (TTR), INR variability, major and minor bleeding events, incidence of CVA and other thrombotic events will be undertaken. Original Hypothesis: There will be a difference in the proportion of time that patients spend in their therapeutic range and the amount of adverse events that occur between those who use a CoaguChek monitor and those who use standard clinic monitoring of their INR. The primary outcome will be time in therapeutic range (TTR). Secondary outcomes will be INR variability, minor / major bleeding complications and thromboembolic events.

Conditions

Congenital Heart Disease; Congenital Heart Defect; Adult Congenital Heart Disease

Keywords

Warfarin therapy; INR monitoring

Outcome Measures

Primary Outcomes (1)

• Time in therapeutic range (TTR)

  The time the patient remains within their therapeutic INR range

  12 months

Secondary Outcomes (4)

• INR variability

  12 months

• Number of Adverse events

  12 months

• Patient satisfaction

  12 months

• Health related quality of life (HRQoL): Health related quality of life scores

  12 months

Study Arms (2)

Clinic monitoring

Patients who attend a warfarin clinic for management of their INR

Home monitoring

Patients who undertake home monitoring of their INR using a CoaguChek POC device

Diagnostic Test: INR monitoring using a CoaguChek POC device

Interventions

INR monitoring using a CoaguChek POC device DIAGNOSTIC_TEST

INR monitoring using a CoaguChek POC device

Home monitoring

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who attend an ACHD clinic in the Royal Victoria Hospital, Belfast

You may qualify if:

• + years old
• Adult Congenital Heart Disease (ACHD)
• attend a clinic in the RVH
• Able to understand, speak, read and write in English
• Patients who currently home manage their INR using a CoaguChek system and are able to submit information electronically

You may not qualify if:

• Patients using a CoaguChek S monitor, as this is an older monitor which uses a different mechanism to measure INR compared with the newer models
• Patients who have been using a CoaguChek \<6 months.
• Patients who are cyanotic will be excluded if their haematocrit is \>55
• Patients who are pregnant will be excluded as warfarin is not prescribed during the first and third trimesters of pregnancy.
• Clinic monitoring cohort
• + years, have ACHD
• Attend a clinic in the RVH
• Able to understand, speak, read and write in English
• INR managed by a warfarin clinic
• Able to submit information electronically
• Patients who have been on warfarin \<6 months.
• Patients who are pregnant will be excluded as warfarin is not prescribed during the first and third trimesters of pregnancy.

Sponsors & Collaborators

• University of Ulster: lead
• Belfast Health and Social Care Trust: collaborator

Study Sites (1)

Royal Victoria Hospital

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ciara Hughes, PhD

  Ulster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 23, 2019
• Study Start: September 30, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)