Evaluating Quality of Life of AF Patients Following a Bleed
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnant women
- •Patients with active cancer
- •Patients unable to consent for themselves
- •Patient on concomitant antiplatelet therapy
结局指标
主要结局
Patient quality of life in both primary and secondary care settings as measured by EQ-5D-5L score
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 3 months following first completion of study survey
Patient quality of life in both primary and secondary care settings as measured by
次要结局
- 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.)
- 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.)
- 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.)
- 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.)