Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection

Not Applicable

Completed

• Conditions: Sequela; Quality of Life
• Interventions: Other: no interventional study

• Registration Number: NCT04005560
• Lead Sponsor: Nantes University Hospital

Brief Summary

The aim of this study is to assess patient's quality of life 5 to 10 years after a severe bacterial infection with hospitalization in a intensive unit care. The population is derived from the DIABACT III study. The investigators will include every patient still alive. To evaluate our question, patients and their parents will answer quality of life questionnaires. The investigators will also have telephone interviews with the parents to know somatic and psychological effects on their child.

The investigators will see if quality of life and sequelae differ depending on various studied factors.

Detailed Description

The aim of this study is to assess patient's quality of life 5 to 10 years after hospitalization in intensive car unit for a severe bacterial infection. The population is derived from DIABACT III study, and includes all patients still alive.

To evaluate their quality of life, patients and parents will answer specific questionnaries. The Pediatric Quality of Life inventory (PedSQL) has various versions for children depending on their age, adults and parents. The investigators will get physical, emotional, social and academic scores.

To assess somatic and psychological effect after the severe bacterial infection, the investigators will have telephone interviews with the parents, with many questions about organs disorders, specialized medical follow-up, medication, need physical or material assistance, financial and psychological family impact... The investigators will examine data from DIABACT III study to assess determinants of the quality of life for these patients.

Study Timeline

• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-02
• Study Start: 2019-12-26
• Primary Completion: 2020-02-15
• Study Completion: 2020-02-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Every patients from DIABACT III study still alive at the beginning of this study

Exclusion Criteria

• Patients who did not respond to the questionnaire
• Inability to contact the patient and family
• No fixed postal address

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient	no interventional study	Score of PedSQL who is the Pediatric Quality of Life Questionnaire

Primary Outcome Measures

Name	Time	Method
This quality of life will be evaluated by a questionnaire, the Pediatric Quality of Life inventory.	6 months	The Pediatric Quality of Life inventory questionnaire has various versions depending on the patient age, from 5 years old to adult age. Patients will answers many questions in the academic, emotional, physical and social fields. It exists the same questionnaire adapted for parents. At the end, there is a score for each field and a total score.

Secondary Outcome Measures

Name	Time	Method
Identify quality of life determinants.	6 months	DIABACT III database has factors that could affect quality of life.
Assess long-term sequelae: evaluate somatic and psychological effects. We will have telephone interviews with the parents.	6 months	During the telephone interview, we will ask many questions about organs disorders and psychological disorders (Strenghts and Difficulties Questionnaire), specialized medical follow-up, medication, need physical or material assistance, financial and psychological family impact

Trial Locations

Locations (1)

CHU Nantes; 🇫🇷 Nantes, France