NCT06873672Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. márc. 13. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 360 (tervezett)
- Első benyújtás
- 2025. márc. 4.
- Kezdés
- 2025. ápr. 1.
- Elsődleges befejezés
- 2027. márc. 31.
- Fő szponzor
- RenJi Hospital
- Betegségek
- Gyermekkori daganatok, Neuroblasztóma, Vesedaganat
- NCT-szám
- NCT06873672
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 360
- 2025. ápr. 1. és az elsődleges befejezés (2027. márc. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 5 év – 16 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Guizhou Medical University | Guiyang | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.