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Completed

NCT Number: NCT04005560

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.

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Key information

Conditions

Quality of Life Bacterial Infections Bacterial Infections and Mycoses Infections Sequela

Age range

6 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nantes

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Interventional study

Other

no interventional study

Primary outcomes

  1. This quality of life will be evaluated by a questionnaire, the Pediatric Quality of Life inventory.

    Time frame: 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 outcomes

  1. Identify quality of life determinants.

    Time frame: 6 months

    DIABACT III database has factors that could affect quality of life.

  2. Assess long-term sequelae: evaluate somatic and psychological effects. We will have telephone interviews with the parents.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2019
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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