CompletedNot Applicable

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

Brazil1,916 participantsStarted 2024-06-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Quality of life

Timeframe: 90 days after hospital discharge

Trial details

NCT IDNCT06343545

SponsorHospital Israelita Albert Einstein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-05

View on ClinicalTrials.gov More Acute Respiratory Failure trials