NCT05333445已完成不适用
Assessing the Nurse-led Educational Intervention in Patients Undergoing Catheter Ablation for Atrial Fibrillation: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- changes from the baseline and better score in the validated ASTA questionnaire of the intervention group compared to the control group at 12 months in quality of life of patients .
研究概览
简要总结
The study aims to examine the effect of nurse-led education program on quality of life, atrial fibrillation (AF) risk factors, AF symptomatology, arrhythmia recurrence rate, and readmission rate after AF catheter ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Derivatives from the outpatient clinic of the center itself, as well as patients referred from other centers that have ours as a reference for a first AF ablation procedure.
- •Have signed the informed consent.
排除标准
- •Patients with cognitive impairment or disorientation.
- •Patients with problems of comprehension or expression of Spanish or Catalan.
- •Patients who are part of the medical or nursing group.
- •Patient with defined heart failure with a left ventricular ejection fraction (LVEF) less than 40% and a NYHA III or IV.
结局指标
主要结局
changes from the baseline and better score in the validated ASTA questionnaire of the intervention group compared to the control group at 12 months in quality of life of patients .
时间窗: 12 months
We will use the second part of ASTA questionnaire: it consists of 13 questions and the answers are measured using a Likert frequency scale from "Never = 0" to "Always = 4". Higher scores on this scale represent poorer quality of life.
次要结局
- differences between both groups in the score obtained in the adapted AFKAT questionnaire patient's knowledge of AF.(3 months)
- differences between both groups in the score received by the patients in the User Experience Questionnaire based on the Picker-33 Patient Experience Questionnaire(3 months)
- calls and emails received(12 months)
- number of participants with recurrences at AF rhythm(12 months)
- number of patients who have the AF risk factor within normal parameters(12 months)
- Differences between both groups in intensity, frequency and severity of symptoms related to AF evaluated with the validated ASTA questionnaire(12 months)
- number of participants with re-hospitalisation or emergency room visits for cardiovascular cause(12 months)
研究者
Josep Lluis Mont Girbau
Head of Arrythmia Unit
Hospital Clinic of Barcelona
研究点 (2)
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