Evaluating Quality of Life of AF Patients Following a Bleed (EQUAL-AF)

Swansea University

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04921176

279646

Details and patient eligibility

About

EQUAL-AF is an observational feasibility study which will determine if there is a long-term effect of bleeding for patients diagnosed with AF, who are taking anticoagulants. The investigators will use three validated questionnaires/PROMs (AFEQT, EQ5D-3L, and PACT-Q) to gather data from a patient perspective. Patients will complete all questionnaires no more than 4 weeks following a bleed and a second time 3 months later. As this study tests feasibility, progression criteria will apply. The primary objective is to assess recruitment success to ensure that the patient population is accessible and willing to engage with the research team. Additionally, the investigators will look to identify the need for a specific bleeding PROM which will assess long-term quality of life impact for patients experiencing bleeds while anticoagulated.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Adult patients (>= 18 years old)
• Patients who can understand all study information and literature to provide fully informed consent
• Atrial fibrillation (AF) as the primary diagnosis
• Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment
• Receiving oral anticoagulation therapy for AF

Exclusion Criteria:

• Pregnant women
• Patients with active cancer
• Patients unable to consent for themselves
• Patient on concomitant antiplatelet therapy

Trial design