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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005560
• Other study ID #: RC19_0128
• Status: Completed
• Phase: N/A
• Start date: December 26, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: October 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Infection
• Quality of Life
• Sequela

Intervention

Other:
• no interventional study
no interventional study

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identify quality of life determinants.	DIABACT III database has factors that could affect quality of life.	6 months
Secondary	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