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临床试验/NCT04637113
NCT04637113已完成不适用

Singapore's Health Outcomes After Critical Illness in Kids: the SHACK Study: A Longitudinal Mixed-methods Study in Singapore to Explore the Health Outcomes of Children and Their Parents in the First Six Months After PICU Discharge

KK Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
To describe and compare the change in total score of the Paediatric Quality of Life Inventory Version 4.0 (PedsQL™) in children at baseline from 6 months after PICU discharge.

研究概览

简要总结

What is the problem? Every year about 2.5 million children are affected by critical illness and require admission to the pediatric intensive care unit (PICU). However, both children and their parents may encounter difficulties after critical illness. Children affected physically may have difficulties in breathing, eating, and drinking. Parents have reported feeling symptoms of stress such as nightmares and excessive worries after PICU discharge. Currently, the investigators do not know when and how the problems unfold and what harm does it cause. Without this information, healthcare professionals are not equipped to support these families after PICU discharge.

Research Plan? To understand how critical illness could affect the physical, emotional, and social experiences of children age 1 month to 18 years of age and their parents in the first 6 months after a PICU admission.

144 children and their parents will be followed from the time of PICU admission to 6 months after discharge. Children and their parents will complete surveys to measure physical, social, emotional and function outcomes. A total of 12 families will be interviewed at 1 and 3 months after PICU discharge. Using the data provided to map out any trend or changes in this information over time.

Why is this study important? To better understand the experience and health consequences of children and their parents in the first six months after PICU admission. This information would help to identify potential areas to improve the negative consequence of children and their families after a severe illness. Results will be shared to the PICU survivors and their families, national organizations, international pediatric intensive care community to improve the experiences and health outcomes following a PICU admission.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Opted for a "Do Not Resuscitate" status for their child and/or
  • Had participated in the current study in a previous PICU admission within the recruitment period.

结局指标

主要结局

To describe and compare the change in total score of the Paediatric Quality of Life Inventory Version 4.0 (PedsQL™) in children at baseline from 6 months after PICU discharge.

时间窗: baseline and 6 months

The PedsQL instrument consists of 23 items that evaluate 4 domains: physical, emotional, social, and school functioning with summary scores available for physical and psychological health. It is scored using a 5-point Likert scale from 0 (never) to 4 (A lot) with a possible score of 0 to 100.

次要结局

  • To investigate the risk factors for parental PTSD using the PTSD Checklist for DSM-5 (PCL-5) six months after their child's' PICU discharge.(6 months)
  • To determine the correlation between race/ethnicity, children's health baseline, and PICU factors with a total score of the Paediatric Quality of Life Inventory Version 4.0 (PedsQL™) after PICU discharge.(6 months)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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