Singapore's Health Outcomes After Critical Illness in Kids

Critical Illness Clinical Trial

— SHACK  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04637113
• Other study ID #: theSHACKStudy:Singapore
• Status: Active, not recruiting
• Start date: January 14, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Pediatric ALL
• Post Intensive Care Unit Syndrome

Intervention

Other:
• This is a non-interventional study
This is a non-interventional study.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	University of Plymouth

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Abela KM, Wardell D, Rozmus C, LoBiondo-Wood G. Impact of Pediatric Critical Illness and Injury on Families: An Updated Systematic Review. J Pediatr Nurs. 2020 Mar-Apr;51:21-31. doi: 10.1016/j.pedn.2019.10.013. Epub 2019 Dec 23. — View Citation

Manning JC, Pinto NP, Rennick JE, Colville G, Curley MAQ. Conceptualizing Post Intensive Care Syndrome in Children-The PICS-p Framework. Pediatr Crit Care Med. 2018 Apr;19(4):298-300. doi: 10.1097/PCC.0000000000001476. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	baseline and 6 months
Secondary	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.	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.	6 months
Secondary	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.	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.	6 months