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

February 20, 2026 updated by: Hospital Israelita Albert Einstein

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1916

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 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)
90 days after hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rehospitalization
Time Frame: 30 days after hospital discharge
New hospitalization
30 days after hospital discharge
Return to work
Time Frame: 90 days after hospital discharge
Return to work or usual activities (work, study)
90 days after hospital discharge
Mortality
Time Frame: From study enrollment (ICU admission) to 90 days after hospital discharge
All cause mortality
From study enrollment (ICU admission) to 90 days after hospital discharge
Days alive and free of hospital
Time Frame: From study enrollment (ICU admission) to 90 days after hospital discharge
Days alive and free of hospital (not hospitalized)
From study enrollment (ICU admission) to 90 days after hospital discharge
Anxiety and Depression
Time Frame: 90 days after hospital discharge
Anxiety and depression measured according to Hospital Anxiety and Depression Scale
90 days after hospital discharge
New disability in instrumental activities of daily living
Time Frame: 90 days after hospital discharge
Incidence of new disabilities for instrumental activities of daily living assessed by the Lawton & Brody scale
90 days after hospital discharge
Physical dependence
Time Frame: 90 days after hospital discharge
Prevalence of moderate, severe, or total physical disability assessed by the modified Barthel Index
90 days after hospital discharge
Clinical Status
Time Frame: 90 days after hospital discharge
Ordinal scale from using World Health Organization
90 days after hospital discharge
Cognitive impairment
Time Frame: 90 days after hospital discharge
Prevalence of cognitive impairment assessed by the Telephone Interview for Cognitive Status
90 days after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Israelita Albert Einstein

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Adriano Pereira, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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