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The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life

Recruitingn/aAges 5 Years - 16 YearsAllWenjing Zhou
NCT06535087 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective observational study aims to assess the health-related quality of life (HRQoL) of 200 children (ages 5-16) with bronchial asthma, allergic rhinitis, or both, and their 200 parents, comparing 100 children receiving specific immunotherapy with 100 receiving routine treatment. Using EQ-5D-Y(EuroQol five dimensions questionnaire, youth version), disease-specific scales, and newly developed Chinese versions of EQ-5D-Y and EQ-HWB-S (EuroQol health and well-being questionnaire, short version), the study evaluates HRQoL changes over 1 and 2 years and explores the impact on caregiver burden and spillover effects. A control group of 100 healthy children and their parents will be included. Data collection involves baseline and follow-up surveys, clinical data from medical records, and statistical analyses to compare treatment effects and validate measurement tools.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Children: 1. Aged 5-16 years; 2. Diagnosed with bronchial asthma, allergic rhinitis, or both (persistent, duration ≥4 weeks) by a respiratory or allergy specialist; 3. Guardian has signed the informed consent form; 4. Able to understand and complete the questionnaire; 5. Outpatients or inpatients at the Pediatrics Department of Renji Hospital in Shanghai. 2. Parents: 1. The primary caregiver of the enrolled child; 2. Accompanied the child to the hospital on the day of the visit; 3. Signed the informed consent form; 4. Able to understand and complete the questionnaire. Exclusion Criteria: 1. Children: 1. Poor compliance; 2. Already received specific immunotherapy at another hospital; 3. Unable to independently read and complete the questionnaire; 4. Lost to follow-up or discontinued treatment. 2. Parents: 1. Unwilling to sign the informed consent form; 2. Unable to complete the questionnaire due to physical condition or educational level.
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What it tests

  • Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis
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Where

1 site
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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