Quality of Life (QOL)NCT06873672
Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China
An observational study of Quality of Life (QOL) and Patient-Reported Outcome Measures (PROMs), run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Quality of Life (QOL), Patient-Reported Outcome Measures (PROMs), Pneumonia Childhood
- Type of treatment
- Injection or infusion
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2027
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be recruited from three tertiary hospitals different cities in China. The study will enroll paediatric patients aged 5-16 years who are receiving routine care for pneumonia, central nervous system (CNS) solid tumours, or immune thrombocytopenic purpura (ITP). These conditions represent common and clinically significant paediatric health issues requiring hospitalization or specialized treatment. The study will also recruit primary caregivers, who are typically parents or long-term family caregivers responsible for the child's daily care and medical decision-making.
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guizhou Medical University
Guiyang, Guizhou, 550025
Zhihao Yang, PhD, +8618302637542, zhihao_yang_cn@126.com
About this study
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
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.
Read the 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 widely used HRQoL measurement tools, but their psychometric properties in Chinese paediatric populations remain underexplored. Understanding how these instruments perform across different administration modes (self-complete, interviewer-administered, and proxy) and in comparison to other established HRQoL measures such as Pediatric Quality of Life Inventory (PedsQL) is essential for improving their application in paediatric healthcare. This study aims to evaluate the validity, reliability, and responsiveness of EQ-5D-Y instruments in children with pneumonia, central nervous system (CNS) solid tumours, and immune thrombocytopenic purpura (ITP) in China, contributing to better HRQoL assessment and economic evaluations in paediatric healthcare.
[Study Design] Prospective observational study.
[Primary Objectives] (1) Compare the psychometric performance (validity, reliability, responsiveness) of EQ-5D-Y-3L and EQ-5D-Y-5L in a Chinese paediatric population. (2) Evaluate differences between self-complete (SC), interviewer-administered (IA), and proxy versions of EQ-5D-Y. (3) Assess how EQ-5D-Y compares with PedsQL in measuring paediatric HRQoL.
[Secondary Objectives] (1) Explore caregiver burden and potential spillover effects using EQ-5D-5L and EQ-HWB-S. (2) Examine the influence of children's disease severity, treatment type, and administration mode on children's HRQoL outcomes. (3) Investigate differences in HRQoL measurement properties across three distinct paediatric disease groups.
[Participants] 360 paediatric patient-caregiver dyads, recruited from three hospitals in China. Disease groups include: Pneumonia (n=120), CNS solid tumours (n=120), and Immune thrombocytopenic purpura (ITP) (n=120).
[Methods] (1) Quantitative assessment: All participants will complete EQ-5D-Y-3L or EQ-5D-Y-5L, administered via three administration modes (SC, IA, or Proxy ). PedsQL will be used as a comparator. Baseline survey will be completed on Day 1 at hospital addmission, and follow-up will occur at discharge (≤14 days) to assess test-retext reliability and responsiveness. (2) Qualitative component: Semi-structured interviews (n=25) will explore acceptability, interpretability, and response patterns.
[Inclusion Criteria] (1) Children aged 5-16 years, diagnosed with pneumonia, CNS solid tumours, or ITP. (2) Primary caregivers (parents/legal guardians) of the participating children. (3) Ability to complete study questionnaires in Mandarin Chinese.
[Study Endpoints] (1) Completion of follow-up assessments. (2) Sufficient qualitative and quantitative data to evaluate HRQoL instruments psychometric properties.
[Primary Outcomes] Psychometric evaluation of EQ-5D-Y, including: Test-retest reliability (intraclass correlation coefficients); Construct validity (correlation with PedsQL, and known-groups validity); Responsiveness (effect size and standardized response means); Comparison of administration modes to determine impact on HRQoL scores.
[Secondary Outcomes] Caregiver burden and spillover Effects will be assessed using EQ-5D-5L and EQ-HWB-S to evaluate caregivers' health and well-being. Correlations with children's HRQoL will explore spillover effects.
[Statistical Methods] (1) Reliability: Test-retest reliability via intraclass correlation coefficients (ICC) and Gwet's AC. (2) Validity: Convergent validity using Spearman's correlation with PedsQL. (3) Known-groups validity assessed via ANOVA and t-tests. (4) Responsiveness: Cohen's d effect sizes and Wilcoxon signed-rank tests. (5) Comparison of administration modes: Generalized linear models (GLM) to assess the impact of SC, IA, and proxy versions on HRQoL scores. (6) Thematic analysis will examine factors contributing to ceiling effects, including response interpretation and differentiation challenges, following COREQ guidelines for rigor. (7) Regression model will be used to analyse the correlation between caregiver's HRQoL and children's.
[Dissemination] This study will provide critical insights into the performance of EQ-5D-Y in China, informing its future use in paediatric health research and economic evaluations. Findings will be disseminated through peer-reviewed publications and international conferences.
- Conditions
- Quality of Life (QOL), Patient-Reported Outcome Measures (PROMs), Pneumonia Childhood, Neuroblastoma (NB), Wilms Tumour, Immune Thrombocytopenic Purpura ( ITP )
- Keywords
- Quality of life, children, psychometric measurements, Paediatric pneumonia, Paediatric central nervous system solid tumour, paediatric immune thrombocytopenic purpura, spillover effect
- Medical subject headings
- Neuroblastoma, Wilms Tumor, Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with pneumonia | Children with pneumonia will be recruited from inpatient wards at Guizhou Provincial People's Hospital and affiliated hospitals of Guizhou Medical University. These children are diagnosed with community-acquired pneumonia (CAP) and receive routine paediatric pneumonia treatment, including antibiotic therapy, oxygen support, intravenous fluids, and symptom monitoring, based on national clinical guidelines. | |
| Children with central nervous system (CNS) solid tumours | Children with central nervous system (CNS) solid tumours will be recruited from The Children's Hospital affiliated with Zhejiang University School of Medicine. These children are diagnosed with CNS solid tumours, i.e., Neuroblastoma or Wilms tumour, and are either undergoing active treatment (including surgical resection, chemotherapy, and radiotherapy) or in post-treatment follow-up. | |
| Children with immune thrombocytopenic purpura | Children with immune thrombocytopenic purpura (ITP) will be recruited from paediatric haematology departments at the No.1 Hospital Affiliated to Guizhou Medical University. These children are diagnosed with ITP, a rare autoimmune disorder characterized by low platelet counts and increased bleeding risk. Their treatment varies by disease severity, including observation, corticosteroids, intravenous immunoglobulin (IVIG), or thrombopoietin receptor agonists (TPO-RAs). | |
| Family caregivers | Caregivers in this study include parents and family caregivers who provide long-term care and support for the child's well-being. Parents (biological or adoptive mothers and fathers) are the primary caregivers, responsible for medical decisions, daily care, and emotional support. Family caregivers, including grandparents, older siblings, aunts, or uncles, may assume caregiving roles due to parental absence or additional support needs, assisting with daily care, medical follow-ups, and emotional well-being. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EQ-5D-Y Summary Scores across three disease groups from Baseline to Follow-up
The EQ-5D-Y Summary Scores include: (1) Index Score which is derived using the Chinese value set for EQ-5D-Y-3L; (2) the Level Sum Score (LSS) which is calculated by summing the reported levels across five dimensions of the EQ-5D-Y-3L and EQ-5D-Y-5L (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with higher scores indicating worse health; and (3) the visual analogue scale (EQ VAS), a self-reported global health assessment measured on a 0 to 100 scale, where 0 represents the worst imaginable health and 100 represents the best imaginable health. The change in these scores from baseline to follow-up will be analyzed to assess test-retest reliability, responsiveness and known-groups validity, and will be compared across the three administration modes (self-complete, interviewer-administered, and proxy-reported) and across three disease groups.
Measured: From Day 1 (hospital admission) to hospital discharge (within 14 days)
Secondary outcomes (1)
Caregiver Burden and Spillover Effects Using EQ-5D-5L and EQ-HWB-S
The impact of caregiving burden on parents will be assessed using the EQ-5D-5L and EQ Health and Well-Being Scale (EQ-HWB-S), both of which generate preference-based index scores. The EQ-5D-5L assesses caregivers' health status across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-while the EQ-HWB-S captures a broader range of well-being aspects, including social and emotional impacts such as exhaustion, loneliness, and cognitive difficulties. Index scores for both instruments will be derived using the respective value sets, with higher scores indicating better health and well-being. Correlations between caregiver scores and children's EQ-5D-Y scores will be analyzed to explore spillover effects, distinguishing between caregiving-related burdens and broader family-level impacts.
Measured: At hospital admission (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of Life (QOL)Studies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The EuroQol Research Foundation, Guizhou Provincial People's Hospital, Guizhou Medical University, The Children's Hospital of Zhejiang University School of Medicine, The Affiliated Hospital Of Guizhou Medical University
- Responsible party
- Principal investigator, Wenjing Zhou, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873672
- Sponsor's protocol ID
- 2024-IRB-159
- Other IDs
- 1721-RA
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Qi X, Zhou W, Yang Z, Guannan B, Yang X, Zhang J, Busschbach J. Validation of EuroQol instruments in paediatric patients and their caregivers in China: protocol for a prospective observational study. BMJ Open. 2025 Jun 18;15(6):e102509. doi: 10.1136/bmjopen-2025-102509.
PubMed 40533211
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06873672
- Acronym / sponsor ID
- 2024-IRB-159
- Conditions
- Quality of Life (QOL), Patient-Reported Outcome Measures (PROMs), Pneumonia Childhood, Neuroblastoma (NB), Wilms Tumour, Immune Thrombocytopenic Purpura ( ITP )
- Keywords
- Quality of life, children, psychometric measurements, Paediatric pneumonia, Paediatric central nervous system solid tumour, paediatric immune thrombocytopenic purpura, spillover effect
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- The EuroQol Research Foundation, Guizhou Provincial People's Hospital, Guizhou Medical University, The Children's Hospital of Zhejiang University School of Medicine, The Affiliated Hospital Of Guizhou Medical University
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 widely used HRQoL measurement tools, but their psychometric properties in Chinese paediatric populations remain underexplored. Understanding how these instruments perform across different administration modes (self-complete, interviewer-administered, and proxy) and in comparison to other established HRQoL measures such as Pediatric Quality of Life Inventory (PedsQL) is essential for improving their application in paediatric healthcare. This study aims to evaluate the validity, reliability, and responsiveness of EQ-5D-Y instruments in children with pneumonia, central nervous system (CNS) solid tumours, and immune thrombocytopenic purpura (ITP) in China, contributing to better HRQoL assessment and economic evaluations in paediatric healthcare.
[Study Design] Prospective observational study.
[Primary Objectives] (1) Compare the psychometric performance (validity, reliability, responsiveness) of EQ-5D-Y-3L and EQ-5D-Y-5L in a Chinese paediatric population. (2) Evaluate differences between self-complete (SC), interviewer-administered (IA), and proxy versions of EQ-5D-Y. (3) Assess how EQ-5D-Y compares with PedsQL in measuring paediatric HRQoL.
[Secondary Objectives] (1) Explore caregiver burden and potential spillover effects using EQ-5D-5L and EQ-HWB-S. (2) Examine the influence of children's disease severity, treatment type, and administration mode on children's HRQoL outcomes. (3) Investigate differences in HRQoL measurement properties across three distinct paediatric disease groups.
[Participants] 360 paediatric patient-caregiver dyads, recruited from three hospitals in China. Disease groups include: Pneumonia (n=120), CNS solid tumours (n=120), and Immune thrombocytopenic purpura (ITP) (n=120).
[Methods] (1) Quantitative assessment: All participants will complete EQ-5D-Y-3L or EQ-5D-Y-5L, administered via three administration modes (SC, IA, or Proxy ). PedsQL will be used as a comparator. Baseline survey will be completed on Day 1 at hospital addmission, and follow-up will occur at discharge (≤14 days) to assess test-retext reliability and responsiveness. (2) Qualitative component: Semi-structured interviews (n=25) will explore acceptability, interpretability, and response patterns.
[Inclusion Criteria] (1) Children aged 5-16 years, diagnosed with pneumonia, CNS solid tumours, or ITP. (2) Primary caregivers (parents/legal guardians) of the participating children. (3) Ability to complete study questionnaires in Mandarin Chinese.
[Study Endpoints] (1) Completion of follow-up assessments. (2) Sufficient qualitative and quantitative data to evaluate HRQoL instruments psychometric properties.
[Primary Outcomes] Psychometric evaluation of EQ-5D-Y, including: Test-retest reliability (intraclass correlation coefficients); Construct validity (correlation with PedsQL, and known-groups validity); Responsiveness (effect size and standardized response means); Comparison of administration modes to determine impact on HRQoL scores.
[Secondary Outcomes] Caregiver burden and spillover Effects will be assessed using EQ-5D-5L and EQ-HWB-S to evaluate caregivers' health and well-being. Correlations with children's HRQoL will explore spillover effects.
[Statistical Methods] (1) Reliability: Test-retest reliability via intraclass correlation coefficients (ICC) and Gwet's AC. (2) Validity: Convergent validity using Spearman's correlation with PedsQL. (3) Known-groups validity assessed via ANOVA and t-tests. (4) Responsiveness: Cohen's d effect sizes and Wilcoxon signed-rank tests. (5) Comparison of administration modes: Generalized linear models (GLM) to assess the impact of SC, IA, and proxy versions on HRQoL scores. (6) Thematic analysis will examine factors contributing to ceiling effects, including response interpretation and differentiation challenges, following COREQ guidelines for rigor. (7) Regression model will be used to analyse the correlation between caregiver's HRQoL and children's.
[Dissemination] This study will provide critical insights into the performance of EQ-5D-Y in China, informing its future use in paediatric health research and economic evaluations. Findings will be disseminated through peer-reviewed publications and international conferences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children with pneumonia | – | –Children with pneumonia will be recruited from inpatient wards at Guizhou Provincial People's Hospital and affiliated hospitals of Guizhou Medical University. These children are diagnosed with community-acquired pneumonia (CAP) and receive routine paediatric pneumonia treatment, including antibiotic therapy, oxygen support, intravenous fluids, and symptom monitoring, based on national clinical guidelines. |
| Children with central nervous system (CNS) solid tumours | – | –Children with central nervous system (CNS) solid tumours will be recruited from The Children's Hospital affiliated with Zhejiang University School of Medicine. These children are diagnosed with CNS solid tumours, i.e., Neuroblastoma or Wilms tumour, and are either undergoing active treatment (including surgical resection, chemotherapy, and radiotherapy) or in post-treatment follow-up. |
| Children with immune thrombocytopenic purpura | – | –Children with immune thrombocytopenic purpura (ITP) will be recruited from paediatric haematology departments at the No.1 Hospital Affiliated to Guizhou Medical University. These children are diagnosed with ITP, a rare autoimmune disorder characterized by low platelet counts and increased bleeding risk. Their treatment varies by disease severity, including observation, corticosteroids, intravenous immunoglobulin (IVIG), or thrombopoietin receptor agonists (TPO-RAs). |
| Family caregivers | – | –Caregivers in this study include parents and family caregivers who provide long-term care and support for the child's well-being. Parents (biological or adoptive mothers and fathers) are the primary caregivers, responsible for medical decisions, daily care, and emotional support. Family caregivers, including grandparents, older siblings, aunts, or uncles, may assume caregiving roles due to parental absence or additional support needs, assisting with daily care, medical follow-ups, and emotional well-being. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be recruited from three tertiary hospitals different cities in China. The study will enroll paediatric patients aged 5-16 years who are receiving routine care for pneumonia, central nervous system (CNS) solid tumours, or immune thrombocytopenic purpura (ITP). These conditions represent common and clinically significant paediatric health issues requiring hospitalization or specialized treatment. The study will also recruit primary caregivers, who are typically parents or long-term family caregivers responsible for the child's daily care and medical decision-making.
Key inclusion criteria (12 listed)
- Children (Patients)
- 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).
- Caregivers (Parents/Family Caregivers)
Key exclusion criteria (15 listed)
- Children (Patients)
- Conditions that make it impossible to respond to surveys (e.g., advanced neuromuscular disease, severe paralysis).
- If the child has participated in another HRQoL validation study within the past 6 months.
- Caregivers (Parents/Family Caregivers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in EQ-5D-Y Summary Scores across three disease groups from Baseline to Follow-up
Time frame: From Day 1 (hospital admission) to hospital discharge (within 14 days)
The EQ-5D-Y Summary Scores include: (1) Index Score which is derived using the Chinese value set for EQ-5D-Y-3L; (2) the Level Sum Score (LSS) which is calculated by summing the reported levels across five dimensions of the EQ-5D-Y-3L and EQ-5D-Y-5L (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with higher scores indicating worse health; and (3) the visual analogue scale (EQ VAS), a self-reported global health assessment measured on a 0 to 100 scale, where 0 represents the worst imaginable health and 100 represents the best imaginable health. The change in these scores from baseline to follow-up will be analyzed to assess test-retest reliability, responsiveness and known-groups validity, and will be compared across the three administration modes (self-complete, interviewer-administered, and proxy-reported) and across three disease groups.
1 secondary outcome
Caregiver Burden and Spillover Effects Using EQ-5D-5L and EQ-HWB-S
Time frame: At hospital admission (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 40533211Qi X, Zhou W, Yang Z, Guannan B, Yang X, Zhang J, Busschbach J. Validation of EuroQol instruments in paediatric patients and their caregivers in China: protocol for a prospective observational study. BMJ Open. 2025 Jun 18;15(6):e102509. doi: 10.1136/bmjopen-2025-102509.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life (QOL) and Patient-Reported Outcome Measures (PROMs), run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjing Zhou, PhD (+31685281032, zhoujing2188@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EQ-5D-Y Summary Scores across three disease groups from Baseline to Follow-up (time frame: From Day 1 (hospital admission) to hospital discharge (within 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06873672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.