The Tele-Rehab MV Cluster Stepped-Wedge Randomized Clinical Trial (Tele-Rehab MV)

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)

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Behavioral: Standard of Care; Behavioral: Disability Prevention and Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 1916
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil
    • Hospital Municipal Ronaldo Gazolla
  • Alagoas
    • Arapiraca, Alagoas, Brazil
      • Hospital de Emergência Dr. Daniel Houly
  • Amazonas
    • Manaus, Amazonas, Brazil
      • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
  • Ceará
    • Fortaleza, Ceará, Brazil
      • Hospital de Messejana Dr. Carlos Alberto Studart Gomes (HM)
    • Sobral, Ceará, Brazil
      • Hospital Regional Norte - HRN
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil
      • Hospital Municipal de Salvador
    • Vitória da Conquista, Estado de Bahia, Brazil
      • Hospital Geral de Vitória da Conquista
  • Federal District
    • Brasília, Federal District, Brazil
      • Hospital Regional de Samambaia
  • Goiás
    • Aparecida de Goiânia, Goiás, Brazil
      • Hospital Municipal Aparecida de Goiania - HMAP
    • Goiânia, Goiás, Brazil
      • Hospital Estadual de Doenças Tropicais Dr. Anuar Auad
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Santa Casa de Misericórdia de Belo Horizonte
  • Paraná
    • Londrina, Paraná, Brazil
      • Hospital Universitário - Universidade Estadual de Londrina
  • Paraíba
    • Campina Grande, Paraíba, Brazil
      • Hospital Municipal Pedro I
  • Pernambuco
    • Recife, Pernambuco, Brazil
      • Instituto de Medicina Integral "Prof. Fernando Figueira" - IMIP
  • Piauí
    • Parnaíba, Piauí, Brazil
      • Hospital Estadual Dirceu Arcoverde
  • Rio Grande do Sul
    • Venâncio Aires, Rio Grande do Sul, Brazil
      • Hospital São Sebastião Martir
  • Rondônia
    • Porto Velho, Rondônia, Brazil
      • Centro De Pesquisa Em Medicina Tropical - CEPEM
  • Roraima
    • Boa Vista, Roraima, Brazil
      • Hospital Geral de Roraima - HGR
  • Santa Catarina
    • Lages, Santa Catarina, Brazil
      • Hospital Geral e Maternidade Tereza Ramos
  • Tocantins
    • Augustinópolis, Tocantins, Brazil
      • Hospital Regional de Augustinópolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of Care; Standard of care provided by participating hospitals	Behavioral: Standard of Care; Standard of Care provided by enrolling hospitals
Experimental: Rehabilitation; An implementation bundle of measures to improve outcomes in intensive care unit, hospital, and after hospital discharge, including rehabilitation at home performed through telemedicine.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Health-related quality of life assessed by the Brazilian version of the 5-dimension, 3-level EuroQol scale (EQ-5D-3L)	90 days after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehospitalization	New hospitalization	30 days after hospital discharge
Return to work	Return to work or usual activities (work, study)	90 days after hospital discharge
Mortality	All cause mortality	From study enrollment (ICU admission) to 90 days after hospital discharge
Days alive and free of hospital	Days alive and free of hospital (not hospitalized)	From study enrollment (ICU admission) to 90 days after hospital discharge
Anxiety and Depression	Anxiety and depression measured according to Hospital Anxiety and Depression Scale	90 days after hospital discharge
New disability in instrumental activities of daily living	Incidence of new disabilities for instrumental activities of daily living assessed by the Lawton & Brody scale	90 days after hospital discharge
Physical dependence	Prevalence of moderate, severe, or total physical disability assessed by the modified Barthel Index	90 days after hospital discharge
Clinical Status	Ordinal scale from using World Health Organization	90 days after hospital discharge
Cognitive impairment	Prevalence of cognitive impairment assessed by the Telephone Interview for Cognitive Status	90 days after hospital discharge

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Study Chair: Adriano Pereira, Hospital Israelita Albert Einstein

Publications and helpful links

General Publications

• Cavaliere YF, Moraes RB, Trott G, et al. Statistical analysis plan for a cluster stepped-wedge randomized clinical trial assessing the effects of a multicomponent telemedicine-based intervention on quality of life in adults with respiratory failure requiring mechanical ventilation (Tele-Rehab MV Trial). Crit Care Sci. 2026;38:e20260308. doi: 10.62675/2965-2774.20260308.
• Pereira AJ, Moraes RB, Trott G, Santos MCD, Mocellin D, Andrade AYT, Miozzo AP, Paixao LCM, Schardosin RFC, Batista CL, Roldao ES, Silva CSM, Santos RDRMD, Cavalcanti MICES, Souza JMB, Matos LDNJ, Souza D, Neves JWC, Rech GS, Souza TMA, Silva GND, Itaqui CR, Yoshida SMS, Eid RAC, Camillis MLF, Genena KSR, Garcia LMC, Schaefer EC, Cidade PAP, Mariano NF, Sisto IR, Cruz ACLPD, Correa CL, Maia IR, Oliveira J, Carvalho A, Laguna MR, Ferraz LR, Teixeira C, Cavaliere YF, Zampieri FG, Rosa RG. The impact of a multicomponent telemedicine-based intervention on quality of life in adults with respiratory failure requiring mechanical ventilation: protocol for a cluster stepped-wedge randomized clinical trial (Tele-Rehab MV Trial). Crit Care Sci. 2025 Dec 15;37:e20250136. doi: 10.62675/2965-2774.20250136. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Actual): September 5, 2025
• Study Completion (Actual): September 5, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; COVID-19; acute respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Quality of Health Care; Quality Indicators, Health Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Standard of Care; Rehabilitation
• Other Study ID Numbers: Rehab_PROADI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data belongs to Brazilian Ministry of Health. May be shared upon agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No