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

NCT ID: NCT04005560

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-26

Study Completion Date

2020-02-15

Brief Summary

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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

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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.

Conditions

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Quality of Life Sequela

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patient

Score of PedSQL who is the Pediatric Quality of Life Questionnaire

Group Type OTHER

no interventional study

Intervention Type OTHER

no interventional study

Interventions

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no interventional study

no interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC19_0128

Identifier Type: -

Identifier Source: org_study_id

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