Implementation of a Digital Tool for the Telematic Follow-up and Management of Emotional and Cognitive Sequelae Related to Post-intensive Care Syndrome: Impact on Quality of Life and Functionality
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Health-related quality of life
研究概览
简要总结
Critically ill survivors develop mental health, cognition, and mobility sequelae known as Post-Intensive Care Syndrome (PICS). Clinically significant symptoms of post-traumatic stress, depression, anxiety, and cognitive impairment are frequently observed at short- and long-term after ICU, impacting quality of life of the survivors and their relatives.
The main objective of the project is to optimize, implement and evaluate the impact in quality of life of a digital platform (ICURA) specifically designed for following-up and managing the mental health sequelae related to PICS in ICU survivors and their relatives during the one-year recovery phase.
Methods: Observational, prospective and multicenter study including two cohorts: 1) ICU patients' cohort (ICUcohort), and 2) ICU patients' family cohort (ICU-F-cohort). After ICU discharge, patients will be randomized to participate in a follow-up with ICURA vs. the standard follow-up.
Expected results: Critically ill survivors in the APPICS program after ICU will show better levels of functionality and quality of life than those participants in the usual follow-up. APPICS will contribute to enhancing the prognosis of emotional alterations during the 12 months after ICU both, in ICU survivors, and relatives. Analyzing risk factors, based on demographic and clinical data, will help to the early detection of long-term mental health difficulties in ICU survivors.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years old) critically ill patients admitted to the ICU with or without need of invasive mechanical ventilation (IMV).
排除标准
- •Non-authorization of the relatives and/or patient to inclusion in the study; neurocritical ICU patients.
- •Severe neurological pathology (including dementia or focal brain damage with functional and cognitive impairment) prior to admission to the ICU.
- •Severe psychiatric pathology (schizophrenia, bipolar disorder, major depressive disorder)
- •Intellectual disability (IQ <80).
- •Patients who develop secondary complications (infections, stroke, TBI or any non-transient acquired brain damage) after ICU discharge, that may compromise the results of the emotional and neuropsychological evaluation during the recovery phase
- •Moderate-severe cognitive impairment (Short-IQCODE >85) that impair ICU patients an independent participation in the telematic follow up and accompaniment program
- •Readmission to ICU within 12 months after discharge from ICU
- •Idiomatic barrier (non spanish and/or catalan speaker)
- •Patients with life expectancy <1 year or not subsidiaries of active treatment measures.
研究组 & 干预措施
ICURA follow-up
干预措施: Telehealth follow-up of post-intensive care syndrome (Other)
Standard Group
结局指标
主要结局
Health-related quality of life
时间窗: 1, 6, 12 months after ICU discharge
12-Item Short Form Survey (SF-12) Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Functionality
时间窗: 1, 6, 12 months after ICU discharge
WHO Short Disability Assessement Schedule (WHODAS 2.0) Scores range from 0 to 60, with higher scores indicating higher level of disability.
次要结局
- Anxiety symptoms(1,6,12 months after ICU discharge)
- Depressive symptoms(1, 6, 12 months after ICU discharge)
- Post-Traumatic Stress symptoms(1, 6, 12 months after ICU discharge)
- Cognitive status(1, 6, 12 months after ICU discharge)
研究者
Sol Fernandez-Gonzalo
Principal Investigator
Corporacion Parc Tauli