Acute Respiratory FailureTele-Rehab MVNCT06343545
The Tele-Rehab MV Cluster Stepped-Wedge Randomized Clinical Trial
A study testing Disability Prevention and Rehabilitation in people with Acute Respiratory Failure, run by Hospital Israelita Albert Einstein at 20 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Disability Prevention and Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,916 participants
- Where
- 20 sitesBrazil
- Study dates
- 10 Jun 2024to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Brazil20 sites
Hospital Municipal Aparecida de Goiania - HMAP
Aparecida de Goiânia, Goiás
Hospital de Emergência Dr. Daniel Houly
Arapiraca, Alagoas
Hospital Regional de Augustinópolis
Augustinópolis, Tocantins
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais
Hospital Geral de Roraima - HGR
Boa Vista, Roraima
Hospital Regional de Samambaia
Brasília, Federal District
Hospital Municipal Pedro I
Campina Grande, Paraíba
Hospital de Messejana Dr. Carlos Alberto Studart Gomes (HM)
Fortaleza, Ceará
Hospital Estadual de Doenças Tropicais Dr. Anuar Auad
Goiânia, Goiás
Hospital Geral e Maternidade Tereza Ramos
Lages, Santa Catarina
Hospital Universitário - Universidade Estadual de Londrina
Londrina, Paraná
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Manaus, Amazonas
Hospital Estadual Dirceu Arcoverde
Parnaíba, Piauí
Centro De Pesquisa Em Medicina Tropical - CEPEM
Porto Velho, Rondônia
Instituto de Medicina Integral "Prof. Fernando Figueira" - IMIP
Recife, Pernambuco
Hospital Municipal Ronaldo Gazolla
Rio de Janeiro
Hospital Municipal de Salvador
Salvador, Estado de Bahia
Hospital Regional Norte - HRN
Sobral, Ceará
Hospital São Sebastião Martir
Venâncio Aires, Rio Grande do Sul
Hospital Geral de Vitória da Conquista
Vitória da Conquista, Estado de Bahia
About this study
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)
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.
Read the 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.
- Conditions
- Acute Respiratory Failure
- Being tested
- Standard of Care, Disability Prevention and Rehabilitation
- Keywords
- acute respiratory failure, rehabilitation, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareBehavioural
Standard of Care provided by enrolling hospitals
Disability Prevention and RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Standard of care provided by participating hospitals Receives: 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. Receives: Behavioral: Standard of Care; Behavioral: Disability Prevention and Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Health-related quality of life assessed by the Brazilian version of the 5-dimension, 3-level EuroQol scale (EQ-5D-3L)
Measured: 90 days after hospital discharge
Secondary outcomes (9)
Mortality
All cause mortality
Measured: 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)
Measured: From study enrollment (ICU admission) to 90 days after hospital discharge
Rehospitalization
New hospitalization
Measured: 30 days after hospital discharge
Return to work
Return to work or usual activities (work, study)
Measured: 90 days after hospital discharge
Anxiety and Depression
Anxiety and depression measured according to Hospital Anxiety and Depression Scale
Measured: 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
Measured: 90 days after hospital discharge
Physical dependence
Prevalence of moderate, severe, or total physical disability assessed by the modified Barthel Index
Measured: 90 days after hospital discharge
Clinical Status
Ordinal scale from using World Health Organization
Measured: 90 days after hospital discharge
Cognitive impairment
Prevalence of cognitive impairment assessed by the Telephone Interview for Cognitive Status
Measured: 90 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start10 Jun 2024
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster crossover randomized trial
- Masking
- None (open label)
- Enrolment
- 1,916 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriano Pereira, Study chair, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343545
- Sponsor's protocol ID
- Rehab_PROADI
- Acronym
- Tele-Rehab MV
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data belongs to Brazilian Ministry of Health. May be shared upon agreement
Publications
Cavaliere YF, Moraes RB, Trott G, Santos MCD, Rech GS, Carvalho A, Maia IR, Zampieri FG, Pereira AJ, Rosa RG. 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 Mar 13;38:e20260308. doi: 10.62675/2965-2774.20260308. eCollection 2026.
PubMed 41849488Pereira 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.
PubMed 41417397Rosa RG, Moraes RB, Trott G, Dos Santos MC, Miozzo AP, Andrade A, de Souza JMB, Wanderley J, Mocellin D, de Almeida TM, Dos Santos RDRM, De Matos LDNJ, De Carli RF, Caserta RA, de Souza Roldao E, Ferreira MS, Farias SE, Asato MS, Joao GAP, De Almeida GMB, De Oliveira CD, Junior ROC, Silva MDA, Furtado MJA, De Oliveira DF, Abreu MML, Flores LK, Meira Teles JM, Falcao SNDRS, Fernandes TF, Nobre VC, Crisostomo AM, Rossato EV, da Silva Macedo LM, Boaventura MM, Alves Goncalves FP, Teixeira C, Rolim Ferraz LJ, Cavaliere YF, Zampieri FG, Pereira AJ; Tele-Rehab Trial Group. Integrated Telehealth Rehabilitation and Quality of Life in Mechanically Ventilated Adults: A Randomized Clinical Trial. JAMA. 2026 Jun 10:e2610617. doi: 10.1001/jama.2026.10617. Online ahead of print.
PubMed 42268591
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06343545
- Acronym / sponsor ID
- Tele-Rehab MV / Rehab_PROADI
- Conditions
- Acute Respiratory Failure
- Keywords
- acute respiratory failure, rehabilitation, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,916 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster crossover randomized trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Behavioral: Standard of CareStandard of care provided by participating hospitals |
| Rehabilitation | Experimental | Behavioral: Standard of Care, Behavioral: Disability Prevention and RehabilitationAn implementation bundle of measures to improve outcomes in intensive care unit, hospital, and after hospital discharge, including rehabilitation at home performed through telemedicine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareStandard of Care provided by enrolling hospitals | Behavioural | Rehabilitation, Standard of Care |
| Disability Prevention and RehabilitationThe 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. | Behavioural | Rehabilitation |
Primary outcome
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)
9 secondary outcomes
Mortality
Time frame: 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
Rehospitalization
Time frame: 30 days after hospital discharge
Return to work
Time frame: 90 days after hospital discharge
Anxiety and Depression
Time frame: 90 days after hospital discharge
New disability in instrumental activities of daily living
Time frame: 90 days after hospital discharge
Physical dependence
Time frame: 90 days after hospital discharge
Clinical Status
Time frame: 90 days after hospital discharge
Cognitive impairment
Time frame: 90 days after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 41849488Cavaliere YF, Moraes RB, Trott G, Santos MCD, Rech GS, Carvalho A, Maia IR, Zampieri FG, Pereira AJ, Rosa RG. 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 Mar 13;38:e20260308. doi: 10.62675/2965-2774.20260308. eCollection 2026.
- Background: PubMed 41417397Pereira 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.
- Derived from this study: PubMed 42268591Rosa RG, Moraes RB, Trott G, Dos Santos MC, Miozzo AP, Andrade A, de Souza JMB, Wanderley J, Mocellin D, de Almeida TM, Dos Santos RDRM, De Matos LDNJ, De Carli RF, Caserta RA, de Souza Roldao E, Ferreira MS, Farias SE, Asato MS, Joao GAP, De Almeida GMB, De Oliveira CD, Junior ROC, Silva MDA, Furtado MJA, De Oliveira DF, Abreu MML, Flores LK, Meira Teles JM, Falcao SNDRS, Fernandes TF, Nobre VC, Crisostomo AM, Rossato EV, da Silva Macedo LM, Boaventura MM, Alves Goncalves FP, Teixeira C, Rolim Ferraz LJ, Cavaliere YF, Zampieri FG, Pereira AJ; Tele-Rehab Trial Group. Integrated Telehealth Rehabilitation and Quality of Life in Mechanically Ventilated Adults: A Randomized Clinical Trial. JAMA. 2026 Jun 10:e2610617. doi: 10.1001/jama.2026.10617. Online ahead of print.
- Individual participant dataSharing planned: Yes. Data belongs to Brazilian Ministry of Health. May be shared upon agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriano Pereira study chair
Hospital Israelita Albert Einstein
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disability Prevention and Rehabilitation in people with Acute Respiratory Failure, run by Hospital Israelita Albert Einstein at 20 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 90 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06343545, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.