A Multicentre, Prospective Observational Study to Develop, Evaluate and Validate Patient Reported Outcome Measures (PROMs) for Patients Treated With Cardiac Ablation for Symptomatic Cardiac Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 586
- 试验地点
- 3
- 主要终点
- Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias?
研究概览
简要总结
A multicentre, prospective observational study to develop, evaluate and validate Patient Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic cardiac arrhythmias
详细描述
This study aims to develop, evaluate and validate disease specific PROMs for patients in the UK treated with cardiac ablation for cardiac arrhythmias. The potential benefits include support for clinicians to improve their performance, assisting patients in making informed choices and strengthening audit and research.
Phase 1 of the study will involve patient interviews with approximately 30 patients from 2 sites. These, together with input from a multidisciplinary team, will aim to improve drafts of disease specific questionnaires. This will be followed by Phase 2 which will trial the questionnaires in a group of approximately 600 patients from three sites. In Phase 2 patients will be asked to complete a pre-procedure questionnaire relating to their symptoms, quality of life and procedure expectations. They will also be sent post-procedure questionnaires relating to procedural outcomes, symptoms and quality of life at 8-16 weeks post procedure and at 1 and 5 years post-procedure.
The responses obtained from these PROMs will be used to undertake recommended statistical tests of reliability and validity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with symptomatic cardiac arrhythmias
- •Consented to and awaiting a cardiac ablation procedure
- •Able to read, write and understand English or Welsh
- •Capable of giving informed written consent
排除标准
- •Not able to read, write and understand English or Welsh
- •Not able to provide informed written consent
结局指标
主要结局
Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias?
时间窗: Up to 5 years post ablation
This will be measured using responses to the new tool, EQ5D5L and clinical outcomes. Statistical evidence of the reliability and validity of the instruments will be illustrated via standard statistical methods.
次要结局
- Do replies to the questionnaires show that the tool is responsive to change following ablation treatment?(Average 10 weeks post ablation)
- Do PROMs responses show concurrent, convergent and discriminant validity; corresponding with responses to EQ5D and clinical outcomes?(Up to 5 years post-ablation.)
- Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias?(Average 10 weeks post ablation)
研究者
Dr Grace Carolan-Rees
Director
Cardiff and Vale University Health Board