Assessing 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
This study looks at how having asthma or allergies affects the quality of life for children and their parents, comparing those getting special treatment to those on regular care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 5 Years to 16 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06535087 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the health-related quality of life (HRQoL) of 200 children aged 5-16 with bronchial asthma, allergic rhinitis, or both, alongside their parents. It compares 100 children receiving specific immunotherapy to 100 receiving routine treatment, using validated questionnaires to assess changes in HRQoL over one and two years. A control group of 100 healthy children and their parents will also be included to analyze the impact of allergic diseases on quality of life and caregiver burden. The study aims to provide insights that could enhance clinical management and inform policy for pediatric allergic conditions.
Who should consider this trial
Good fit: Ideal candidates include children aged 5-16 diagnosed with bronchial asthma, allergic rhinitis, or both, along with their primary caregivers.
Not a fit: Patients who have already received specific immunotherapy at another hospital or those unable to complete the questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that enhance the quality of life for children with allergic diseases and their families.
How similar studies have performed: Previous studies have shown that allergen-specific immunotherapy can significantly improve quality of life in patients with allergic diseases, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Wenjing Zhou — Renji Hospital, School of Medicine, Shanghai Jiaotong University
- Study coordinator: Wenjing Zhou
- Email: zhoujing2188@163.com
- Phone: +31685281032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.