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

Primary Purpose

Quality of Life, Sequela

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
no interventional study
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Quality of Life focused on measuring severe bacterial infection, quality of life, long term sequela, pediatric intensive care unit, children

Eligibility Criteria

6 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Nantes

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patient

Arm Description

Score of PedSQL who is the Pediatric Quality of Life Questionnaire

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Identify quality of life determinants.
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.
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

Full Information

First Posted
June 25, 2019
Last Updated
October 20, 2020
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04005560
Brief Title
Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection
Official Title
Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 26, 2019 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Sequela
Keywords
severe bacterial infection, quality of life, long term sequela, pediatric intensive care unit, children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient
Arm Type
Other
Arm Description
Score of PedSQL who is the Pediatric Quality of Life Questionnaire
Intervention Type
Other
Intervention Name(s)
no interventional study
Intervention Description
no interventional study
Primary Outcome Measure Information:
Title
This quality of life will be evaluated by a questionnaire, the Pediatric Quality of Life inventory.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Identify quality of life determinants.
Description
DIABACT III database has factors that could affect quality of life.
Time Frame
6 months
Title
Assess long-term sequelae: evaluate somatic and psychological effects. We will have telephone interviews with the parents.
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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