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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Sequela
• Intervention / Treatment: Other: no interventional study

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 24 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: patient; Score of PedSQL who is the Pediatric Quality of Life Questionnaire	Other: no interventional study; no interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
This quality of life will be evaluated by a questionnaire, the Pediatric Quality of Life inventory.	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify quality of life determinants.	DIABACT III database has factors that could affect quality of life.	6 months
Assess long-term sequelae: evaluate somatic and psychological effects. We will have telephone interviews with the parents.	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	6 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 26, 2019
• Primary Completion (ACTUAL): February 15, 2020
• Study Completion (ACTUAL): February 15, 2020

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; children; severe bacterial infection; pediatric intensive care unit; long term sequela
• Additional Relevant MeSH Terms: Bacterial Infections and Mycoses; Infections; Bacterial Infections
• Other Study ID Numbers: RC19_0128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No