NCT06535087Recruiting
The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life
The Impact of Airway Allergic Diseases on the Health-related Quality of Life of Children and Their Parents (Caregivers): A Prospective Controlled Study
Source: ClinicalTrials.gov · Last updated 2 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 29 Jul 2024
- Start date
- 20 Jul 2024
- Primary completion date
- 23 Jun 2025
- Lead sponsor
- Wenjing Zhou
- Diseases
- Asthma
- NCT number
- NCT06535087
What you commit to
- Study type: Observational
- Planned participants: 600
- From 20 Jul 2024 to the primary completion date, 23 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Children:
- Poor compliance;
- Already received specific immunotherapy at another hospital;
- Unable to independently read and complete the questionnaire;
- Lost to follow-up or discontinued treatment.
Other illness
- Parents:
- Unwilling to sign the informed consent form;
- Unable to complete the questionnaire due to physical condition or educational level.
Who the study is looking for
- Children:
- Aged 5-16 years;
- Diagnosed with bronchial asthma, allergic rhinitis, or both (persistent, duration ≥4 weeks) by a respiratory or allergy specialist;
- Guardian has signed the informed consent form;
- Able to understand and complete the questionnaire;
- Outpatients or inpatients at the Pediatrics Department of Renji Hospital in Shanghai.
- Parents:
- The primary caregiver of the enrolled child;
- Accompanied the child to the hospital on the day of the visit;
- Signed the informed consent form;
- Able to understand and complete the questionnaire.
Age in the registry: 5 years to 16 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
Related publications
- Impact of Allergen-Specific Subcutaneous Immunotherapy on 12-Month Health-Related Quality of Life in Children and Their Parental Caregivers.Allergy Asthma Immunol Res · 2026 · PMID 42547470
This page is information, not medical advice. Discuss any trial with your doctor.