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

NCT06873672 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • The EuroQol Research Foundation

    collaborator OTHER

  • Guizhou Provincial People's Hospital

    collaborator OTHER

  • Guizhou Medical University

    collaborator OTHER

  • The Children's Hospital of Zhejiang University School of Medicine

    collaborator OTHER

  • The Affiliated Hospital Of Guizhou Medical University

    collaborator OTHER

  • RenJi Hospital

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-03-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873672 on ClinicalTrials.gov