Clinical trial NCT06535087: The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life
Official title: The Impact of Airway Allergic Diseases on the Health-related Quality of Life of Children and Their Parents (Caregivers): A Prospective Controlled Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Asthma
Rhinitis, Allergic
Quality of Life
Keywords: pediatric allergic disease, health-related quality of life
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 600
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involves 200 children aged 5-16 years diagnosed with bronchial asthma, allergic rhinitis, or both, along with their 200 parents (direct caregivers). Of these children, 100 will receive allergen-specific immunotherapy, while the other 100 will undergo conventional treatment. Additionally, the control group consists of 100 pairs of healthy children and their parents.

Brief 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.

Detailed description: \[Research Background\] Asthma and allergic rhinitis are common chronic diseases in children, significantly impacting their HRQoL and increasing healthcare burden. Allergen-specific immunotherapy (AIT) is an effective treatment for these conditions, shown to improve symptoms and QoL. This study aims to further understand the impact of AIT on QoL in children and their caregivers, using validated assessment tools and comprehensive clinical data. The findings will contribute to better clinical management and policy-making for pediatric allergic diseases.

\[Study Design\] Prospective observational study.

\[Primary Objectives\] Assess the current health-related quality of life (HRQoL) of children with airway allergic diseases (bronchial asthma, allergic rhinitis, or both) using the EQ-5D-Y and disease-specific scales.

Evaluate and compare the dynamic changes in HRQoL over 1 and 2 years in children undergoing routine treatment versus specific immunotherapy. Analyze the impact of treatment type, disease severity, and treatment outcomes.

Determine the impact of allergic diseases on children's HRQoL by comparing them with healthy controls.

\[Secondary Objectives\] Explore the caregiver burden and spillover effects on parents using the PedsQL Family Impact Module, compared with healthy controls.

Compare the QoL of parents based on different treatment plans, disease severities, and treatment outcomes of their children.

Validate the newly developed Chinese versions of EQ-5D-Y and EQ-HWB-S for parents' QoL assessment.

\[Participants\] 200 children (ages 5-16) diagnosed with bronchial asthma, allergic rhinitis, or both, and their 200 parents (caregivers), divided into two groups: 100 children receiving specific immunotherapy and 100 receiving routine treatment.

Control group: 100 healthy children and their parents.

\[Methods\] Children with Allergies: Complete baseline and two follow-up surveys. Use the EQ-5D-Y-3L (3 level of EQ-5D-Y), EQ VAS (Visual Analogue Scale), PAQLQ (Pediatric Asthma Quality of Life Questionnaire) or JRQLQ-No. 1 (Japanese Rhinoconjunctivitis Quality of Life Questionnaire No. 1 ), and Overall Health Assessment (OHA).

Healthy Children: Complete a single baseline survey using EQ-5D-Y-3L, EQ VAS, and OHA.

Parents: Complete EQ-HWB-S, demographic information, EQ-5D-5L, OHA, and PedsQL (Pediatric Quality of Life Inventory) Family Impact Module.

Clinical data collection from medical records including diagnosis, symptoms, laboratory tests (lung function, allergens, eosinophils, IgE, FeNO\[Fractional Exhaled Nitric Oxide\]), treatment plans, side effects, and complications.

\[Inclusion Criteria\] Children with Allergies: Ages 5-16, diagnosed with bronchial asthma, allergic rhinitis, or both, with continuous treatment for ≥4 weeks. Able to understand and complete questionnaires.

Healthy Children: Ages 5-16, without a history of allergic diseases. Able to understand and complete questionnaires.

Parents: Primary caregivers, present during survey, signed informed consent.

\[Study Endpoints\] Completion of the second follow-up survey by the last enrolled child and parent.

\[Primary Outcomes\] Disease severity (Asthma Control Test, ACT). Laboratory tests (lung function, serum allergens, eosinophils, IgE, oral/nasal FeNO)

\[Statistical Methods\] Compare HRQoL before and after treatment in children and parents, and between allergic and healthy groups using t-tests, Wilcoxon rank-sum tests, chi-square tests, or Fisher's exact tests. Use ANOVA, Kruskal-Wallis tests, and chi-square tests for multiple group comparisons. Analyze correlations between HRQoL and influencing factors using multiple regression. Validate HRQoL scales using variance analysis for construct validity and effect size for responsiveness.

Eligibility 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.

Primary outcomes:
measure: Asthma control level for asthmatic children
timeFrame: Baseline 1 week before treatment; 2 follow-up every 12 months
measure: Severity assessment of allergic rhinitis
timeFrame: Baseline 1 week before treatment; 2 follow-up every 12 months
measure: EQ-5D-Y-3L for assessing health-related quality of life
timeFrame: Baseline 1 week before treatment; 2 follow-up every 12 months
measure: EQ-VAS for assessing health-related quality of life
timeFrame: Baseline 1 week before treatment; 2 follow-up every 12 months
measure: PAQLQ for assessing health-related quality of life in children with asthma
timeFrame: Baseline 1 week before treatment; 2 follow-up every 12 months
measure: JRQLQ-No. 1 for assessing health-related quality of life in children with allergic rhinitis
timeFrame: Baseline 1 week before treatment; 2 follow-up every 12 months
Secondary outcomes:
measure: Pulmonary function for assessing asthma disease severity
timeFrame: Baseline 1 week before treatment; 2 follow-up every 12 months
measure: Peripheral Blood Eosinophils for assessing allergic severity
timeFrame: Baseline 1 week before treatment; 2 follow-up every 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Wenjing Zhou
role: PRINCIPAL_INVESTIGATOR
References: