QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 14
- 主要终点
- Hospital Anxiety and Depression Scale (HADS) anxiety score
研究概览
简要总结
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.
详细描述
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.
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
- 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
- •Indication for ICD implantation either as primary or secondary prevention
- •Patient informed consent
排除标准
- •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
研究组 & 干预措施
Home Monitoring Off
Home Monitoring activated 9 months after implantation (Intervention HM Off)
干预措施: HM Off (Device)
Home Monitoring On
Home Monitoring activated after implantation (Intervention HM On)
干预措施: HM on (Device)
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS) anxiety score
时间窗: 9 and 18 months
次要结局
- Quality of life (SF-12)(9 and 18 months)
- Patient's perception of ICD therapy(9 and 18 months)
- Prevalence of Type D personality among ICD patients(9 and 18 months)
- HADS depression score(9 and 18 months)
- Frequency of contacts between patient and physician(9 and 18 months)
- Patient mobility(9 and 18 months)