The Tele-Rehab MV Cluster Stepped-Wedge Randomized Clinical Trial
NCT06343545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1916
Last updated 2026-02-23
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
Interventions
- 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.
Sponsors & Collaborators
-
Hospital Israelita Albert Einstein
lead OTHER
Principal Investigators
-
Adriano Pereira · Hospital Israelita Albert Einstein
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-10
- Primary Completion
- 2025-09-05
- Completion
- 2025-09-05
Countries
- Brazil
Study Locations
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