NCT00559559已完成不适用
PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 2
- 主要终点
- Reduction in device related anxiety, related to battery depletion, as assessed by the Duru Questionnaire (question 9) Reduction in device related anxiety, related to device malfunction, as assessed by the Duru Questionnaire (question 10)
研究概览
简要总结
This study is intended to look at the effect of the SJM vibrating Patient Notifier™ system, which will warn the patient of possible failures of the implanted system, on reducing patient device related anxiety
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has recently (min. 2 weeks - max. 14 weeks) been implanted with an SJM ICD with the Patient Notifier™ feature;
- •Patient is willing and able to independently comprehend and complete the study-related questionnaires;
- •Patient has signed the study specific informed consent form.
排除标准
- •have already had a Patient Notifier™ alert since implant;
- •had a prior device implant (PM or ICD);
- •have not been discharged from the hospital since device implant;
- •have evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
- •cannot commit to the follow-up schedule;
- •have a life expectancy of less than 1 year;
- •are on a waiting list for a heart transplant;
- •are less than 18 years old;
- •are pregnant;
研究组 & 干预措施
Control Group
Other
Patient Notifier turned OFF
干预措施: ICD implant + Patient Notifier turned OFF (Device)
Treatment group
Experimental
Patient Notifier turned ON
干预措施: ICD Implant + Patient Notifier turned ON (Procedure)
结局指标
主要结局
Reduction in device related anxiety, related to battery depletion, as assessed by the Duru Questionnaire (question 9) Reduction in device related anxiety, related to device malfunction, as assessed by the Duru Questionnaire (question 10)
时间窗: 12months
次要结局
- Reduction in general anxiety Evolution over time in anxiety for the different personality types Cross-overs Sensitivity and Specificity of the Patient Notifier™ Number of appropriate/inappropriate ICD therapies Hospitalizations Mortality(1year)
研究者
研究点 (2)
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