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NCT06873672

Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

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.

Official title: Using EQ-5D-Y to Measure the Health of Patients for Multiple Paediatric Health Conditions: a Project to Validate the Self-complete, Interviewer-administered and Proxy Administered Versions of EQ-5D-Y-3L and EQ-5D-Y-5L in China

Key Details

Gender

All

Age Range

5 Years - 16 Years

Study Type

OBSERVATIONAL

Enrollment

360

Start Date

2025-04-01

Completion Date

2027-12-31

Last Updated

2025-03-13

Healthy Volunteers

Conditions

Quality of Life (QOL)Patient-Reported Outcome Measures (PROMs)Pneumonia Childhood Neuroblastoma (NB)Wilms Tumour Immune Thrombocytopenic Purpura ( ITP )

Inclusion Criteria: * Children (Patients) 1. Age: 5-16 years old. 2. Diagnosis: Clinically confirmed diagnosis of one of the following conditions: Pneumonia (hospitalized due to community-acquired pneumonia); Central Nervous System (CNS) Solid Tumours (receiving active treatment or in post-treatment follow-up); Immune Thrombocytopenic Purpura (ITP) (diagnosed with acute or chronic ITP). 3. Health Status: Cognitively and physically capable of completing HRQoL assessments (for self-complete versions). 4. Language Proficiency: Able to understand and communicate in Mandarin Chinese. 5. Consent: Written informed consent obtained from the primary caregiver and verbal or written assent from the child (if age-appropriate). * Caregivers (Parents/Family Caregivers) 1. Primary Caregiver: Must be a parent or a long-term family caregiver (e.g., grandparent, older sibling, aunt, or uncle). 2. Involvement: Directly responsible for the daily care and medical decision-making of the child. 3. Language Proficiency: Able to understand and complete both the self-complete and proxy-reported HRQoL assessments in Mandarin Chinese. 4. Consent: Willing to provide informed consent for participation. Exclusion Criteria: * Children (Patients) 1. Severe Cognitive or Developmental Impairment: Diagnosed with intellectual disability, autism spectrum disorder, or any neurological condition that prevents understanding and completing HRQoL assessments. 2. Severe Physical Disability: Conditions that make it impossible to respond to surveys (e.g., advanced neuromuscular disease, severe paralysis). 3. Comorbidities: Presence of another major chronic illness that could significantly affect HRQoL measurement (e.g., severe congenital heart disease, uncontrolled epilepsy). 4. Recent Participation in Similar Studies: If the child has participated in another HRQoL validation study within the past 6 months. 5. Inability to Complete Study Follow-Up: Expected to be transferred to another hospital or relocated during follow-up. * Caregivers (Parents/Family Caregivers) 1. Not the Primary Caregiver: 2. Individuals who do not have daily caregiving responsibilities for the child. Cognitive Impairment or Severe Health Conditions: 3. Caregivers with severe mental illness, dementia, or a medical condition that affects their ability to complete surveys. 4. Language Barrier: Unable to understand and complete HRQoL assessments in Mandarin Chinese. 5. Refusal to Participate: Caregivers who decline to provide informed consent.

Locations (1)

Guizhou Medical University

Guiyang, Guizhou, China