Official Title
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)
Brief Summary

To evaluate, through a randomized clinical trial in groups/clusters (stepped wedge), theimpact of specific bundles for disability prevention and early rehabilitation, focused on3 domains (ICU, ward and post-discharge), on health-related quality of life and otherlong- and short-term outcomes, 90 days after hospital discharge, in critically illpatients affected by hypoxemic acute respiratory failure.

Detailed Description

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.

Completed
Acute Respiratory Failure

Behavioral: Standard of Care

Standard of Care provided by enrolling hospitals

Behavioral: Disability Prevention and Rehabilitation

The study intervention is an evidence-based, multicomponent program focused on disability
prevention and rehabilitation strategies, implemented during the patient's ICU stay,
continued through ward admission, and extending up to two months post-hospital discharge.

Eligibility Criteria

Inclusion Criteria:

1. Aged ≥18 years

2. 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.

3. Need for invasive mechanical ventilation.

Exclusion Criteria:

1. Severe underlying disease with a life expectancy of less than 3 months;

2. Absence of a responsible family member for cases of patients with communication
difficulties (aphasia, severe cognitive impairment, non-native speakers of
Portuguese);

3. Absence of telephone contact;

4. Participants already included in the study;

5. Unavailability to carry out telephone follow-ups.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Brazil
Locations

Hospital de Emergência Dr. Daniel Houly
Arapiraca, Alagoas, Brazil

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Manaus, Amazonas, Brazil

Hospital de Messejana Dr. Carlos Alberto Studart Gomes (HM)
Fortaleza, Ceará, Brazil

Hospital Regional Norte - HRN
Sobral, Ceará, Brazil

Hospital Municipal de Salvador
Salvador, Estado de Bahia, Brazil

Hospital Geral de Vitória da Conquista
Vitória da Conquista, Estado de Bahia, Brazil

Hospital Regional de Samambaia
Brasília, Federal District, Brazil

Hospital Municipal Aparecida de Goiania - HMAP
Aparecida de Goiânia, Goiás, Brazil

Hospital Estadual de Doenças Tropicais Dr. Anuar Auad
Goiânia, Goiás, Brazil

Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil

Hospital Universitário - Universidade Estadual de Londrina
Londrina, Paraná, Brazil

Hospital Municipal Pedro I
Campina Grande, Paraíba, Brazil

Instituto de Medicina Integral "Prof. Fernando Figueira" - IMIP
Recife, Pernambuco, Brazil

Hospital Estadual Dirceu Arcoverde
Parnaíba, Piauí, Brazil

Hospital São Sebastião Martir
Venâncio Aires, Rio Grande do Sul, Brazil

Centro De Pesquisa Em Medicina Tropical - CEPEM
Porto Velho, Rondônia, Brazil

Hospital Geral de Roraima - HGR
Boa Vista, Roraima, Brazil

Hospital Geral e Maternidade Tereza Ramos
Lages, Santa Catarina, Brazil

Hospital Regional de Augustinópolis
Augustinópolis, Tocantins, Brazil

Hospital Municipal Ronaldo Gazolla
Rio de Janeiro, Brazil

Adriano Pereira, Study Chair
Hospital Israelita Albert Einstein

Hospital Israelita Albert Einstein
NCT Number
Keywords
acute respiratory failure
Rehabilitation
Covid-19
MeSH Terms
COVID-19
Standard of Care
Rehabilitation