Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring
Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies. A close therapeutic relationship between patients and physicians, resulting in short reaction times to ICD-treated arrhythmic events and, in an optimised antiarrhythmic therapy, may help the patients to deal with their situations in the best possible way.
The researchers investigate the influence of automatic remote patient monitoring on QOL, anxiety, and depression in ICD patients, and kind and frequency of (un-)scheduled patient-physician contacts. They also evaluate monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy.
研究概览
详细说明
Our study investigates the influence of automatic remote patient monitoring on quality of life (QOL), anxiety and depression in patients with implantable cardioverter-defibrillators (ICDs), and frequency of (un-)scheduled patient-physician contacts. The study also evaluates monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy.
The patients will receive BIOTRONIK Lexos-T or Lumos-T ICD models, with the integrated Home Monitoring capability. The latter allows wireless, everyday transfer of the essential status and therapy data from the ICD memory to a website accessible by the attending physicians. The website is managed by BIOTRONIK Home Monitoring Service Center.
Patients will be randomised into:
- Group 1: Home Monitoring is established from the outset.
- Group 2: Home Monitoring is introduced 9 months after ICD implantation.
Follow-up for both groups is 18 months.
Study Hypothesis: Home Monitoring improves the Hospital Anxiety Score in ICD patients.
Preoperatively, HADS (Hospital Anxiety and Depression Scale), Questionnaire on Type D personality (DS 14), and SF-12 Questionnaire will be applied. At follow-up visits every 3 months, HADS, SF-12 Questionnaire, Shock Sensation Questionnaire, number of shocks since preceding follow-up visit, and medications (cardiovascular drugs, psychopharmacological drugs and barbiturates) will be evaluated. Home Monitoring ICD Impact Questionnaire will be collected at the final 18-month follow-up.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ried、奥地利、4910
- Krankenhaus der Barmherzigen Schwestern Ried
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Wien、奥地利、1140
- Hanusch-Krankenhaus
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Coswig、德国、06869
- Herzzentrum Coswig
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Erlangen、德国、91054
- Universitätsklinikum Erlangen
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Nuernberg、德国、90491
- Krankenhaus Martha-Maria Nürnberg
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Würzburg、德国、97080
- Universitätsklinikum Würzburg
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Zürich、瑞士
- Universitätsklinikum
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Indication for ICD implantation either as primary or secondary prevention
- Patient informed consent
Exclusion Criteria:
- ICD replacement indication
- Indication for cardiac resynchronisation therapy
- Inability to fully understand psychosomatic questionnaires, especially cognitive impairment or German language deficits
- Co-morbidities with a resulting life expectancy of less than one year
- Psychosomatic disease (requiring psychiatric therapy)
- Age <18 years
- Patients who are already enrolled in another study
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Home Monitoring On
Home Monitoring activated after implantation (Intervention HM On)
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Home Monitoring activated after implantation
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实验性的：Home Monitoring Off
Home Monitoring activated 9 months after implantation (Intervention HM Off)
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Home Monitoring activated 9 months after implantation
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Hospital Anxiety and Depression Scale (HADS) anxiety score
大体时间：9 and 18 months
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9 and 18 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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HADS depression score
大体时间：9 and 18 months
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9 and 18 months
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Quality of life (SF-12)
大体时间：9 and 18 months
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9 and 18 months
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Prevalence of Type D personality among ICD patients
大体时间：9 and 18 months
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9 and 18 months
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Frequency of contacts between patient and physician
大体时间：9 and 18 months
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9 and 18 months
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Patient's perception of ICD therapy
大体时间：9 and 18 months
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9 and 18 months
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Patient mobility
大体时间：9 and 18 months
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9 and 18 months
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合作者和调查者
调查人员
- 首席研究员：Matthias Wilhelm, Dr. Med.、University Hospital Inselspital, Berne
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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