Evaluating Quality of Life of AF Patients Following a Bleed

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating Quality of Life of AF Patients Following a Bleed

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the feasibility of identifying and recruiting patients with both minor and major bleeds as a result of anticoagulant treatment for AF associated events | Recruitment of a minimum of 50 eligible patients onto the study | Following 6 months recruitment window | 
| Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score | Patient quality of life in both primary and secondary care settings as measured by EQ-5D- | Within 4 weeks following bleed | 
| Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score | Patient quality of life in both primary and secondary care settings as measured by EQ-5D- | 3 months following first completion of study survey | 
| Patient quality of life in both primary and secondary care settings as measured by Atrial Fibrillation Effect of Quality of Life score (AFEQT) | Patient quality of life in both primary and secondary care settings as measured by Atrial | Within 4 weeks following bleed | 
| Patient quality of life in both primary and secondary care settings as measured by Atrial Fibrillation Effect of Quality of Life score (AFEQT) | Patient quality of life in both primary and secondary care settings as measured by Atrial | 3 months following first completion of study survey | 
| Patient quality of life in both primary and secondary care settings as measured by Perception of Anticoagulant Treatment Questionnaire (PACT-Q) | Patient quality of life in both primary and secondary care settings as measured by | Within 4 weeks following bleed | 
| Patient quality of life in both primary and secondary care settings as measured by Perception of Anticoagulant Treatment Questionnaire (PACT-Q) | Patient quality of life in both primary and secondary care settings as measured by | 3 months following first completion of study survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe differences in QoL by type of bleed as measured by clinical classification of minor and major bleeds using BARC scale. | A small number of additional relevant questions will be asked of the patient, regarding when the bleed occurred, the nature of the bleed and their current treatment. | One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient. | 
| Identifying the treatment received and the nature of the bleed experienced by capturing type of anticoagulant combined with bleed details from each participant. | Identifying the treatment received and the nature of the bleed experienced by capturing | One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient. | 
| Insight into issues experienced with bleeding from participant perspective as measured by structured qualitative interviews. | Insight into issues experienced with bleeding from participant perspective as measured by structured qualitative interviews. | Following completion of both 4 week and 3 month timepoint. | 
| Appropriateness of three chosen PROMs (EQ5D, AFEQT and PACT-Q, part 2) in capturing QoL data for patients who have experienced a bleed while anticoagulated as measured by responses to suitability questions within the participant survey. | Additional questions to evaluate appropriateness of chosen PROMs in capturing Quality of Life issues for patients diagnosed with AF who are anticoagulated | One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Bleed events, Patient Reported Outcome Measure, Anticoagulation