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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Other | Standard of care provided by participating hospitals |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Behavioral | Standard of Care provided by enrolling hospitals |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriano Pereira | Hospital Israelita Albert Einstein | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Emergência Dr. Daniel Houly | Arapiraca | Alagoas | Brazil | |||
| Fundação de Medicina Tropical Dr. Heitor Vieira Dourado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41849488 | Background | 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. | |
| 41417397 |
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Data belongs to Brazilian Ministry of Health. May be shared upon agreement
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Cluster crossover randomized trial
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| 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. |
|
| From study enrollment (ICU admission) to 90 days after hospital discharge |
| Rehospitalization | New hospitalization | 30 days after hospital discharge |
| Return to work | Return to work or usual activities (work, study) | 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 |
| 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 |
| 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. |
| 42268591 | Derived | Rosa 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. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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