NCT06395558招募中不适用
Internet-Based Interventions for Cardiac Arrest Survivors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 137
- 试验地点
- 4
- 主要终点
- Composite outcome
研究概览
简要总结
Anxiety, depression and cognitive impairment symptoms are common among cardiac arrest survivors. This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster anxiety and depression symptoms in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor will be unaware about the study arm allocation of the patient
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospital discharge after out-of-hospital cardiac arrest with Cerebral Performance Category 1 or 2
- •HADS anxiety or depression ≥ 8 and/or TICS ≤ 31
- •Informed consent for participation in the study
- •Native Italian speaker or adequate understanding of the Italian language
- •Adequate ability to use the web to guarantee access to the contents
排除标准
- •Previous cognitive dysfunction
- •Previous psychiatric disease
- •Previous episode of out-of-hospital cardiac arrest
结局指标
主要结局
Composite outcome
时间窗: 12 months
HADS (Hospital Anxiety and Depression Scale) score \< 8 for depression or anxiety and TICS (Telephone Interview for Cognitive Status) \> 31
次要结局
- SF-12 (Short Form Health Survey 36)(12 months)
- NRS (Neurobehavioural rating scale), PCRS (Patient Competency Rating Scale)(12 months)
- Zarit Burden Inventory (ZBI)(12 months)
- TICS (Telephone Interview for Cognitive Status)(12 months)
- HADS (Hospital Anxiety and Depression Scale) - Caregiver(12 months)
- SF-12 (Short Form Health Survey 36) - Caregiver(12 months)
- NRS (Neurobehavioural rating scale)(12 months)
- PCRS (Patient Competency Rating Scale)(12 months)
- Sexual Interest and Satisfaction Scale (SISS)(12 months)
- PSQI (Pittsburgh Sleep Quality Index) - Caregiver(12 months)
- HADS (Hospital Anxiety and Depression Scale) value(12 months)
- Pittsburgh Sleep Quality Index (PSQI)(12 months)
研究者
研究点 (4)
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