NCT06851884

Effectiveness of Informational and Educational Tools to Improve the Experience of Relatives of ICU Patients. RELIEF, a Platform Trial

Efficacité d'Interventions Pour améliorer le vécu Des Proches de Patients hospitalisés en réanimation. RELIEF, un Essai Plateforme

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 562 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The admission of a patient to an intensive care unit (ICU) is associated with high levels of acute stress, anxiety, and depression among relatives, as well as extreme emotions such as fear, guilt, distress, and helplessness. In addition to these emotions, relatives also struggle to understand the information provided by the medical team-only half of the information is fully understood. These emotional and cognitive difficulties can become obstacles in decision-making processes and may have medium- and long-term consequences on their psychological well-being, particularly in terms of post-traumatic stress disorder (PTSD), anxiety, and depression. Three months after the patient is discharged from the ICU, one-third of relatives exhibit symptoms of PTSD. The aim of this research is to propose a variety of informational and educational tools to improve relatives' understanding of both the ICU context and the information provided, with the goal of reducing the risk of developing PTSD in the months following the patient's discharge or death.

Conditions

• Post Traumatic Stress Disorder PTSD

Interventions

Type	Name	Description
OTHER	Standard of Care (SOC)	Universal welcome leaflet on patient admission
OTHER	Video capsules	3 video capsules of 3 minutes each
OTHER	Cartoon	3 cartoons
OTHER	Virtual reality	3 virtual reality programs
OTHER	Set of "end-of-life and grief" informational and educational tools	Including a video capsule, a cartoon, and a kit of two leaflets
OTHER	Standard of Care (SOC)	Universal welcome leaflet on patient admission

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-12-31
• Completion: 2027-01-31
• First posted: 2025-02-28
• Last updated: 2025-02-28