To Reduce Recurrence of Symptomatic Atrial Fibrillation and Improve Quality of Life After Catheter Ablation for Atrial Fibrillation by App-based Mental Training (Mental AF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Atrial Fibrillation (AF) 6 questionnaire score
研究概览
简要总结
Atrial fibrillation (AF) is one of the most common heart rhythm disorders and it is associated with a variety of symptoms leading to a considerable deterioration in quality of life. The Mental-AF trial is intended to inquire if an app-based mental training can reduce the occurrence of symptomatic AF episodes within the blanking period, i.e. the first three months after catheter ablation for AF.
详细描述
To explore the potential of a daily app-based mindfulness mental training in improving AF symptoms, assessed by self-reported outcome measures, i.e. the AF 6 questionnaire, AF Effect on QualiTy of Life (AFEQT) and Patient Reported Outcome Measurement Information System (PROMIS) Global Health questionnaires, as well as in reducing AF burden in 7-day-Holter, within the first 12 weeks following AF ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing AF ablation with symptomatic paroxysmal or chronic atrial fibrillation (EHRA II-IV)
- •Availability of smart phone with the capability to run android 5 or iOS 9 or newer versions
- •Capability to use mobile phone applications
- •Internet access
- •Consent to study participation
排除标准
- •Patients < 18 years of age
- •Unavailability of smart phone running at least Android 5 or iOS 9
- •Pregnancy
结局指标
主要结局
Atrial Fibrillation (AF) 6 questionnaire score
时间窗: 12 weeks, assessed weekly
Atrial fibrillation specific symptomatic outcome defined by AF 6 sum scores during the first 12 weeks following AF ablation, based on a 10-point Likert scale, ranging from 0 (no symptoms) to 10 (severe symptoms), sum scores ranging from 0 to 60.
次要结局
- Atrial fibrillation burden(Follow up (3 months))
- Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score(Follow up at 12 months)
- Blood pressure(Follow up (3 months))
- Patient-Reported Outcome Measurement Information System (PROMIS) Global Health 10 score(Follow up (3 months))
- Heart Rate(Follow up (3 months))