NCT06873672Not yet recruiting
Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China
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
Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 360 (estimated)
- First submitted
- 4 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Neuroblastoma, Kidney cancer, Childhood cancers
- NCT number
- NCT06873672
What you commit to
- Study type: Observational
- Planned participants: 360
- From 1 Apr 2025 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Children (Patients)
- Severe Cognitive or Developmental Impairment: Diagnosed with intellectual disability, autism spectrum disorder, or any neurological condition that prevents understanding and completing HRQoL assessments.
- Severe Physical Disability:
- Conditions that make it impossible to respond to surveys (e.g., advanced neuromuscular disease, severe paralysis).
- 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:
- If the child has participated in another HRQoL validation study within the past 6 months.
- Inability to Complete Study Follow-Up: Expected to be transferred to another hospital or relocated during follow-up.
- Caregivers (Parents/Family Caregivers)
- Not the Primary Caregiver:
- Individuals who do not have daily caregiving responsibilities for the child.
- Cognitive Impairment or Severe Health Conditions:
- Caregivers with severe mental illness, dementia, or a medical condition that affects their ability to complete surveys.
- Language Barrier: Unable to understand and complete HRQoL assessments in Mandarin Chinese.
- Refusal to Participate: Caregivers who decline to provide informed consent.
Who the study is looking for
- Children (Patients)
- Age: 5-16 years old.
- 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).
- 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).
- Caregivers (Parents/Family Caregivers)
- 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.
- Consent: Willing to provide informed consent for participation.
Age in the registry: 5 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.