The Impact of Airway Allergic Diseases on the Health-related Quality of Life of Children and Their Parents (Caregivers): A Prospective Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 16
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Renji Hospital, School of Medicine, Shanghai Jiaotong University
RECRUITING
Shanghai
Contact Information
Primary
Wenjing Zhou
zhoujing2188@163.com
+31685281032
Time Frame
Start Date: 2024-07-20
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 600
Treatments
Allergic disease group
Receiving: 1) Subcutaneous immunotherapy and 2) Standard Treatment for Asthma and Rhinitis.
Healthy control Group
Healthy children aged 5-16 from the Shanghai region, with no history of allergic diseases, and without any intervention.
Related Therapeutic Areas
Sponsors
Leads: Wenjing Zhou

This content was sourced from clinicaltrials.gov

Similar Clinical Trials