Status:
NOT_YET_RECRUITING
Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
The EuroQol Research Foundation
Guizhou Provincial People's Hospital
Conditions:
Quality of Life (QOL)
Patient-Reported Outcome Measures (PROMs)
Eligibility:
All Genders
5-16 years
Brief 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....
Detailed Description
\[Research Background\] Health-related quality of life (HRQoL) is a key indicator of well-being in paediatric patients, particularly for those with chronic illnesses. The EQ-5D-Y-3L and EQ-5D-Y-5L are...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06873672
Start Date
April 1 2025
End Date
December 31 2027
Last Update
March 13 2025
Active Locations (1)
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1
Guizhou Medical University
Guiyang, Guizhou, China, 550025