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临床试验/NCT06343545
NCT06343545已完成不适用

Evaluation of an Integrated Multicomponent Telemedicine-Based Intervention on Health-Related Quality of Life in Adults With Acute Respiratory Failure Requiring Mechanical Ventilation (Tele-Rehab MV Trial)

Hospital Israelita Albert Einstein20 个研究点 分布在 1 个国家目标入组 1,916 人开始时间: 2024年6月10日最近更新:
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
1,916
试验地点
20
主要终点
Quality of life

研究概览

简要总结

To evaluate, through a randomized clinical trial in groups/clusters (stepped wedge), the impact of specific bundles for disability prevention and early rehabilitation, focused on 3 domains (ICU, ward and post-discharge), on health-related quality of life and other long- and short-term outcomes, 90 days after hospital discharge, in critically ill patients affected by hypoxemic acute respiratory failure.

详细描述

Acute respiratory failure requiring invasive mechanical ventilation is associated with significant mortality rates. Furthermore, survivors often develop new physical, mental, and cognitive disabilities, as well as worsening clinical conditions, which can significantly impair their health-related quality of life. COVID-19 remains a notable cause of acute respiratory failure and long-term disabilities,6 with the added potential to cause persistent symptoms regardless of the infection's initial severity. Although the incidence of SARS-CoV-2-related respiratory failure has declined with the widespread adoption of vaccination, it persists as an endemic cause of pneumonia, particularly among patients with significant comorbidities, and is often part of the differential diagnosis in severe cases of acute hypoxemic respiratory failure. While bundles of interventions including analgesia optimization, sedation minimization, early mobilization, and delirium prevention, as well as screening for individuals at risk of new disabilities for early rehabilitation have been recommended to prevent disabilities in critical care patients, no large randomized clinical trial has yet demonstrated a significant impact on long-term health-related quality of life. Additionally, the burden of disability following critical illness is often associated with patients' inability to attend clinic-based follow-up, and telemedicine may serve as a tool to reduce healthcare inequalities. Accordingly, the primary objective of this cluster stepped-wedge randomized clinical trial is to assess the impact of a multicomponent telemedicine-based intervention on the health-related quality of life of patients with acute hypoxemic respiratory failure requiring invasive mechanical ventilation, evaluated 90 days after hospital discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Aged ≥18 years
  • Admission to the ICU with hypoxemic acute respiratory failure in whom SARS-CoV-2 infection is part of the differential diagnosis will be enrolled. This does not imply that COVID-19 is the primary suspected cause, but rather that it is considered at least a possible (though not necessarily probable) diagnosis at the time of ICU admission.
  • Need for invasive mechanical ventilation.

排除标准

  • Severe underlying disease with a life expectancy of less than 3 months;
  • Absence of a responsible family member for cases of patients with communication difficulties (aphasia, severe cognitive impairment, non-native speakers of Portuguese);
  • Absence of telephone contact;
  • Participants already included in the study;
  • Unavailability to carry out telephone follow-ups.

研究组 & 干预措施

Standard of Care

Other

Standard of care provided by participating hospitals

干预措施: Standard of Care (Behavioral)

Rehabilitation

Experimental

An implementation bundle of measures to improve outcomes in intensive care unit, hospital, and after hospital discharge, including rehabilitation at home performed through telemedicine.

干预措施: Standard of Care (Behavioral)

Rehabilitation

Experimental

An implementation bundle of measures to improve outcomes in intensive care unit, hospital, and after hospital discharge, including rehabilitation at home performed through telemedicine.

干预措施: Disability Prevention and Rehabilitation (Behavioral)

结局指标

主要结局

Quality of life

时间窗: 90 days after hospital discharge

Health-related quality of life assessed by the Brazilian version of the 5-dimension, 3-level EuroQol scale (EQ-5D-3L)

次要结局

  • Rehospitalization(30 days after hospital discharge)
  • Return to work(90 days after hospital discharge)
  • Mortality(From study enrollment (ICU admission) to 90 days after hospital discharge)
  • Days alive and free of hospital(From study enrollment (ICU admission) to 90 days after hospital discharge)
  • Anxiety and Depression(90 days after hospital discharge)
  • New disability in instrumental activities of daily living(90 days after hospital discharge)
  • Physical dependence(90 days after hospital discharge)
  • Clinical Status(90 days after hospital discharge)
  • Cognitive impairment(90 days after hospital discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

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