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临床试验/NCT04005560
NCT04005560已完成不适用

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

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2019年12月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
This quality of life will be evaluated by a questionnaire, the Pediatric Quality of Life inventory.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
6 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Every patients from DIABACT III study still alive at the beginning of this study

排除标准

  • Patients who did not respond to the questionnaire
  • Inability to contact the patient and family
  • No fixed postal address

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Identify quality of life determinants.(6 months)
  • Assess long-term sequelae: evaluate somatic and psychological effects. We will have telephone interviews with the parents.(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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