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)

Key Points

• This research aims to outline the analysis plan for the Tele-Rehab MV Trial evaluating a telemedicine intervention.
• Cluster stepped-wedge randomized clinical trial design
• Comparison of telemedicine program and usual care
• Focus on disability prevention and rehabilitation strategies during ICU care
• Plan developed prior to database lock
• Specific results not available before database lock
• Aim to identify effects on quality of life through statistical analysis
• Potential improvements in rehabilitation noted in preliminary assessments