Actively Recruiting
The Impact of Airway Allergic Diseases on the Health-related Quality of Life of Children and Their Parents: A Prospective Controlled Study
Led by Wenjing Zhou · Updated on 2024-08-02
600
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how airway allergic diseases like bronchial asthma and allergic rhinitis affect the health-related quality of life (HRQoL) of children aged 5 to 16 and their parents. It compares children receiving specific immunotherapy with those receiving routine treatment, as well as a healthy control group, to explore the impact on both children and caregiver burden over time. The study uses validated questionnaires and clinical data to assess changes in quality of life and disease severity. Children in the study are divided into groups receiving either subcutaneous allergen-specific immunotherapy or standard treatments such as inhaled corticosteroids and antihistamines. Healthy children without allergic diseases serve as a control group. Data collection includes baseline and follow-up surveys at 1 and 2 years to evaluate quality of life using tools like EQ-5D-Y and disease-specific questionnaires. Clinical assessments include lung function tests, blood tests, and allergy markers. Participants and their parents complete questionnaires at the start and during follow-ups to measure quality of life and caregiver impact. Researchers collect medical records for clinical data and use statistical methods to compare outcomes between treatment groups and healthy controls. The study monitors disease severity and treatment effects over 2 years, aiming to validate new measurement tools and better understand the burden of pediatric allergic diseases on families.
CONDITIONS
Brief Title
The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 16 years
- Diagnosed with bronchial asthma, allergic rhinitis, or both lasting at least 4 weeks
- Guardian has signed informed consent
- Able to understand and complete questionnaires
- Outpatients or inpatients at the Pediatrics Department of Renji Hospital
- Parents are primary caregivers accompanying the child
- Parents have signed informed consent
- Parents able to understand and complete questionnaires
You will not qualify if you...
- Children with poor compliance
- Children who previously received specific immunotherapy at another hospital
- Children unable to read or complete questionnaires independently
- Children lost to follow-up or discontinued treatment
- Parents unwilling to sign informed consent
- Parents unable to complete questionnaires due to physical or educational limitations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week before treatment
Participants with allergic diseases complete baseline surveys and clinical data collection before starting their assigned treatment or routine care. Healthy controls complete a single baseline survey.
1 baseline visit (in-person)
Duration - 2 years
Participants undergo routine treatment or specific immunotherapy while completing follow-up surveys and clinical assessments to monitor health-related quality of life and disease severity over time.
2 follow-up visits, annually
Trial Site Locations
Total: 1 location
1
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
W
Wenjing Zhou
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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