SHACK: Singapore's Health Outcomes After Critical Illness in Kids

Sponsor

KK Women's and Children's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04637113

Collaborator

University of Plymouth (Other)

220

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric ALL Critical Illness Post Intensive Care Unit Syndrome	Other: This is a non-interventional study

Study Design

Study Type:

Observational

Anticipated Enrollment :

220 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
All patients admitted to the PICU meeting eligible criteria This is a non-interventional study.	Other: This is a non-interventional study This is a non-interventional study.

Arm

Intervention/Treatment

All patients admitted to the PICU meeting eligible criteria

This is a non-interventional study.

Other: This is a non-interventional study

This is a non-interventional study.

Outcome Measures

Primary Outcome Measures

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. [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.

Secondary Outcome Measures

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]
The Paediatric Quality of Life Inventory Version 4.0 (PedsQL™) total score will be used to compare the difference between Chinese, Malay, and Indian families. This 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.
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]
PTSD Checklist for DSM-5 (PCL-5) assesses the 20 Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-5) symptoms of post-traumatic stress disorder. The 20 items self-report measure is scored on a rating a 5-point Likert scale from 0 (Not at all) to 4 (Extremely). The symptoms severity score ranges from 0-80. A cut-off score between 31-33 is indicative of probable PTSD.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Child inclusion criteria:

Aged 1 month to 18 years at the point of PICU admission
PICU total length of stay (LOS) ≥ 48 hours at the point of PICU discharge

Parents inclusion criteria:

(a) Parent or legal guardian; (b) cohabits with the child
For the family home to be the planned location following hospital discharge.

Exclusion Criteria:

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.