The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life
Recruiting now
Conditions studied: Pediatric Asthma, Rhinitis, Allergic, Quality of Life
In brief
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.
Key facts
- Study ID
- NCT06535087
- Run by
- Wenjing Zhou
- People needed
- 600
- Starts
- 2024-07-20
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2024-08-02
Who can join
Age: 5 and older, up to 16. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Parents:
- Unwilling to sign the informed consent form;
- Unable to complete the questionnaire due to physical condition or educational level.
Where it is running
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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