Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China (NCT06873672) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China
China360 participantsStarted 2025-04-01
Plain-language summary
The goal of this observational study is to validate the EQ-5D-Y-3L and EQ-5D-Y-5L in measuring health-related quality of life (HRQoL) for paediatric patients with different health conditions in China. The main research questions focus on comparing the psychometric performance of EQ-5D-Y-3L and EQ-5D-Y-5L, evaluating the differences between self-complete (SC), interviewer-administered (IA), and proxy-administered (Proxy) versions, and assessing their validity against other HRQoL measures like PedsQL. The study will recruit 360 inpatient-caregiver dyads from three disease groups, i.e., pneumonia, paediatric central nervous system (CNS) solid tumours, and immune thrombocytopenic purpura (ITP), using cross-sectional and longitudinal surveys. Baseline assessments will be conducted at hospital admission, with follow-up at hospital discharge (within 14 days). A qualitative component will explore acceptability and interpretation of EQ-5D-Y. The findings will contribute to the methodological development of EQ-5D-Y, with potential implications for HRQoL measurement and economic evaluations in paediatric healthcare.
Who can participate
Age range5 Years – 16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: 5-16 years old.
✓. Diagnosis: Clinically confirmed diagnosis of one of the following conditions:
✓. Health Status: Cognitively and physically capable of completing HRQoL assessments (for self-complete versions).
✓. Language Proficiency: Able to understand and communicate in Mandarin Chinese.
✓. Consent: Written informed consent obtained from the primary caregiver and verbal or written assent from the child (if age-appropriate).
✓. Primary Caregiver: Must be a parent or a long-term family caregiver (e.g., grandparent, older sibling, aunt, or uncle).
✓. Involvement: Directly responsible for the daily care and medical decision-making of the child.
✓. Language Proficiency: Able to understand and complete both the self-complete and proxy-reported HRQoL assessments in Mandarin Chinese.
Exclusion criteria
✕. Severe Cognitive or Developmental Impairment: Diagnosed with intellectual disability, autism spectrum disorder, or any neurological condition that prevents understanding and completing HRQoL assessments.
What they're measuring
1
Change in EQ-5D-Y Summary Scores across three disease groups from Baseline to Follow-up
Timeframe: From Day 1 (hospital admission) to hospital discharge (within 14 days)
✕. Comorbidities: Presence of another major chronic illness that could significantly affect HRQoL measurement (e.g., severe congenital heart disease, uncontrolled epilepsy).
✕. Recent Participation in Similar Studies:
✕. Inability to Complete Study Follow-Up: Expected to be transferred to another hospital or relocated during follow-up.
✕. Not the Primary Caregiver:
✕. Individuals who do not have daily caregiving responsibilities for the child.
✕. Caregivers with severe mental illness, dementia, or a medical condition that affects their ability to complete surveys.