Mindfulness Meditation and Patient Education for Symptom Management in Individuals With Atrial Fibrillation(AF): Do They Need to Be Offered Together?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
研究概览
简要总结
The aim of this project is to determine whether the entire intervention (Mindfulness meditation, AF education, and weekly phone visits) that is nurse delivered to individuals with paroxysmal atrial fibrillation is more effective than a combination, single or no intervention in the reduction of overall AF symptoms, anxiety, and negative illness perception; or the improvement of quality of life (QOL) and functional status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Individuals with Symptomatic Paroxysmal Atrial Fibrillation
- •A symptomatic episode of PAF within last 6 months
- •18 years old or greater
- •Able to read and understand English
- •Able to participate in weekly phone calls
- •Able to attend two video visit/phone sessions that are 6 weeks apart
排除标准
- •Diagnosed with low cardiac function (NYHA Class IV)
- •Life expectancy of less than 6 months
- •Hospitalized in prior 3 months for illness other than PAF
- •Previously practiced mindfulness
- •Cognitive impairment
结局指标
主要结局
Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores
时间窗: Baseline (Initial), 12 month
Atrial Fibrillation Burden and Symptom Severity will be calculated from the patient-completed responses on the Atrial Fibrillation Symptom Severity Scale-Symptom Burden can range from 3.25 (minimally bothersome) to 30 (continuous symptomatic episodes) and is based on event frequency (1-10), duration (1.25-10), and global episode (1-10). Symptom severity is based on symptom specific subscale with range from 0(no symptoms) to 35 (severe symptoms).
Change from Baseline in AF Quality of Life Score
时间窗: Baseline (Initial), 12 month
Quality of Life will be assessed using a patient completed questionnaire, Atrial Fibrillation Effect on Quality of Life Questionnaire. The AFEQT score is a combined score of 21 items (21-100) with a higher score representing greater QOL.
次要结局
- Change from Baseline in Anxiety(Baseline (Initial), 12 months)
研究者
Paul Wang
Professor of Medicine
Stanford University