NCT06535087 The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life
| NCT ID | NCT06535087 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wenjing Zhou |
| Condition | Pediatric Asthma |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-07-20 |
| Primary Completion | 2025-06-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2024-07-20 with a primary completion date of 2025-06-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Wenjing Zhou
PRINCIPAL INVESTIGATOR
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Frequently Asked Questions
Who can join the NCT06535087 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 16 Years, studying Pediatric Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06535087 currently recruiting?
Yes, NCT06535087 is actively recruiting participants. Contact the research team at zhoujing2188@163.com for enrollment information.
Where is the NCT06535087 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06535087 clinical trial?
NCT06535087 is sponsored by Wenjing Zhou. The principal investigator is Wenjing Zhou at Renji Hospital, School of Medicine, Shanghai Jiaotong University. The trial plans to enroll 600 participants.
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