Comparison of home and clinic monitoring of INR in patients with CHD
Research type
Research Study
Full title
Comparison of efficacy and outcomes for home and standard clinic monitoring of INR in patients with congenital heart disease.
IRAS ID
234309
Contact name
Ciara Hughes
Contact email
Sponsor organisation
Ulster University
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Congenital heart disease is a common birth defect that affects more than 1% of the population, and which can result in an increased risk of stroke. To reduce this risk, some patients are prescribed warfarin to thin their blood. This medication needs to be regularly monitored by a test called an international normalized ratio (INR). Patients are given a range that their INR levels should be kept within. Previously this could only be monitored by having blood taken and sent to a laboratory to be tested and patients had to attend regular clinical appointments for this test. Now this test can be done at home using a device called the CoaguChek monitor. This study will compare how effective these two methods of INR monitoring are by studying two groups of patients, one using the traditional clinical methods of monitoring INR and the other using the home monitoring system. We will analyze how much time patients’ INR levels stay within their required range, how much their INR varies over time, whether they have any episodes of bleeding caused by warfarin, occurrence of stroke or blood clots. Participants in this study will complete a health related quality of life survey and a questionnaire to examine how satisfied they are with the way their INR is monitored. This study will let us know which group of patients have better controlled INR levels, better health related quality of life and higher levels of satisfaction with their form of INR monitoring.
Before ACHD patients undertake training on the use of INR home monitoring, their GP must consent to being responsible for the patient's INR management. GPs will be invited to participate in interviews to determine the impact of GP's views on the uptake of INR home monitoring.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0357
Date of REC Opinion
13 Nov 2018
REC opinion
Favourable Opinion