Evaluating Quality of Life of AF Patients Following a Bleed

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04921176
• Lead Sponsor: Swansea University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-22
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-10
• Primary Completion: 2022-03-09
• Study Completion: 2022-03-09
• Status Verified: 2022-09
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Identifying the treatment received and the nature of the bleed experienced by capturing type of anticoagulant combined with bleed details from each participant.	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
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.	Insight into issues experienced with bleeding from participant perspective as measured by structured qualitative interviews.
Observe differences in QoL by type of bleed as measured by clinical classification of minor and major bleeds using BARC scale.	One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.	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.
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.	One data point at 4 weeks using the validated questionnaires and a follow-up at 3 months for each patient.	Additional questions to evaluate appropriateness of chosen PROMs in capturing Quality of Life issues for patients diagnosed with AF who are anticoagulated

Trial Locations

Locations (3)

Arrhythmia Alliance; 🇬🇧 Oxford, England, United Kingdom

Morriston Hospital; 🇬🇧 Swansea, West Glamorgan, United Kingdom

Swansea City GP Cluster; 🇬🇧 Swansea, West Glamorgan, United Kingdom