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

NCT06343545 | Completed

• 1 other identifier: Rehab_PROADI
• Study Type: interventional
• Target: 1,916
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

Acute Respiratory Failure

Keywords

acute respiratory failure; rehabilitation; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• Rehospitalization

  30 days after hospital discharge

• Return to work

  90 days after hospital discharge

• Anxiety and Depression

  90 days after hospital discharge

Study Arms (2)

Standard of Care

OTHER

Standard of care provided by participating hospitals

Behavioral: Standard of Care

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.

Behavioral: Standard of Care; Behavioral: Disability Prevention and Rehabilitation

Interventions

Standard of Care BEHAVIORAL

Standard of Care provided by enrolling hospitals

Rehabilitation; Standard of Care

Disability Prevention and Rehabilitation BEHAVIORAL

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.

Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (20)

Hospital de Emergência Dr. Daniel Houly

Arapiraca, Alagoas, Brazil

Location

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Manaus, Amazonas, Brazil

Location

Hospital de Messejana Dr. Carlos Alberto Studart Gomes (HM)

Fortaleza, Ceará, Brazil

Location

Hospital Regional Norte - HRN

Sobral, Ceará, Brazil

Location

Hospital Municipal de Salvador

Salvador, Estado de Bahia, Brazil

Location

Hospital Geral de Vitória da Conquista

Vitória da Conquista, Estado de Bahia, Brazil

Location

Hospital Regional de Samambaia

Brasília, Federal District, Brazil

Location

Hospital Municipal Aparecida de Goiania - HMAP

Aparecida de Goiânia, Goiás, Brazil

Location

Hospital Estadual de Doenças Tropicais Dr. Anuar Auad

Goiânia, Goiás, Brazil

Location

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Universitário - Universidade Estadual de Londrina

Londrina, Paraná, Brazil

Location

Hospital Municipal Pedro I

Campina Grande, Paraíba, Brazil

Location

Instituto de Medicina Integral "Prof. Fernando Figueira" - IMIP

Recife, Pernambuco, Brazil

Location

Hospital Estadual Dirceu Arcoverde

Parnaíba, Piauí, Brazil

Location

Hospital São Sebastião Martir

Venâncio Aires, Rio Grande do Sul, Brazil

Location

Centro De Pesquisa Em Medicina Tropical - CEPEM

Porto Velho, Rondônia, Brazil

Location

Hospital Geral de Roraima - HGR

Boa Vista, Roraima, Brazil

Location

Hospital Geral e Maternidade Tereza Ramos

Lages, Santa Catarina, Brazil

Location

Hospital Regional de Augustinópolis

Augustinópolis, Tocantins, Brazil

Location

Hospital Municipal Ronaldo Gazolla

Rio de Janeiro, Brazil

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 41417397 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care; Rehabilitation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Adriano Pereira

  Hospital Israelita Albert Einstein

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster crossover randomized trial

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: June 10, 2024
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

BR (20)