Summary

Atrial Fibrillation (AF) is where some people experience unusual heart rhythm which sometimes leads to an AF-stroke. AF is common and many factors can increase the risk of developing it. There are several ways which AF can be managed, including treatment to reset the heartbeat to a normal rhythm. Doctors may give patients medicine called anticoagulants, sometimes called blood thinners, to help prevent blood cells clumping together to make blood clots. A major side effect of taking anticoagulant medicine is bleeding which does not stop easily and is thought to be bothersome for someone with AF. There is not enough research into the effect of bleeding on a patient’s health and welfare.

Bleeding is a natural consequence of anticoagulation and is of great concern to physicians when anticoagulating patients with atrial fibrillation (AF). Bleeding is often clinically significant, as has been demonstrated in a large number of clinical trials. However, the impact of anticoagulant-related bleeding on patients’ quality of life (QOL) has received little attention to date, and no QOL outcomes were evaluated in the major Phase III trials of the Direct Oral AntiCoagulants (DOACs).

This study sets out to bring the ‘patient voice’ into decisions on anticoagulating patients with AF, by evaluating the implications on patients’ quality of life of experiencing a bleed while anticoagulated.
This study is envisaged in two phases:
1. Feasibility – descriptive study (est. 50-80 patients) of the QOL of AF patients experiencing a bleed, aiming to pilot the mechanism of QOL data collection in this cohort and identify critical challenges to overcome.
2. Full study – larger (est. 200-400 patients), quantitative evaluation comparing QOL of bleeding patients to QOL of controls (similar patients who did not bleed).

Researchers will engage with AF patients to understand what it is like to live with the condition. Information will be gathered from 50-80 AF patients, who have recently had a bleed while anticoagulated, from GP clinics, hospital wards and AF support groups. Patients will be asked to give contact details and basic health details. As there are no questionnaires available which look at how bleeding events affect health and wellbeing, the study will use other existing, good quality questionnaires concerning general issues patients with AF experience. All patients will be asked to complete three questionnaires at two points in the study; no more than four weeks after the bleed event and then three months later. The questionnaires take 20-30 minutes to complete and can be filled in on a tablet like an iPad, or on paper. Ten patients will be contacted after the 3-month questionnaires are complete and asked more bleeding related questions, during a semi-structured interview.

The study will increase awareness of how patients with AF feel bleeding affects their quality of life and to inform larger-scale research on the impact of bothersome bleeding for AF patients.

ClinicalTrials.gov project webpage

Results

This study is now completed and the results can be found here

Contact Details

Trial Manager / Lead Contact: Prof Hayley Hutchings
Phone: 01792 513412
Email: h.a.hutchings@swansea.ac.uk

IRAS ID: 279646;