CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 431 enrolled
Drug / intervention
Hospital diariesbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04961697
NCT04961697N/ACompleted

Family and Patient Outcomes After Pediatric Intensive Care

D'Or Institute for Research and Education·interventional·Posted Jul 14, 2021·Updated Dec 24, 2025

In Brief

A clinical study evaluating Hospital diaries for Post-Intensive Care Syndrome and 5 related conditions. Completed, enrolled 431 participants across 1 site.

Detailed Summary

This study aims to evaluate in the Brazilian context, the impact of the implementation of a diary program on patient and family-centered outcomes after PICU discharge. The intervention investigated will be the use of hospital diaries for the critically ill child in a cross-over study, randomized by clusters in four PICUs of Rio de Janeiro. Family members of children aged 29 days to 12 years, admitted for more than 36 hours will be included and data collection will take place upon admission, at PICU discharge and 60 days after discharge from the PICU. Family-centered outcomes assessed will be: satisfaction with care, anxiety and depression at discharge, incidence of anxiety, depression, PTSD, burden and quality of life in follow-up. Patient-centered outcomes will be assessed in children at discharge and follow-up - quality of life and incidence of new morbidities will be evaluated. The association of clinical, social and demographic variables with family- and patient-centered outcomes will be investigated on an exploratory basis. Burnout Syndrome in PICU health professionals will be assessed before and after the intervention as a proxy of intervention security for PICU staff.

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 14, 2021
Enrollment StartDec 20, 2019
Primary CompletionDec 16, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.0 years ago

Interventions

Hospital diariesbehavioral

Diaries will be used by family members, PICU staff or even the patient himself. They will take daily notes expressing feelings and thoughts and describing events that might help chronologically to better understand the course of disease and PICU stay. Photographs and other important PICU memories may also be used in the diary.