The Impact of Airway Allergic Diseases on the Health-related Quality of Life of Children and Their Parents (Caregivers): A Prospective Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Severity assessment of allergic rhinitis
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •Poor compliance;
- •Already received specific immunotherapy at another hospital;
- •Unable to independently read and complete the questionnaire;
- •Lost to follow-up or discontinued treatment.
- •Unwilling to sign the informed consent form;
- •Unable to complete the questionnaire due to physical condition or educational level.
Arms & Interventions
Allergic disease group
Receiving: 1) Subcutaneous immunotherapy and 2) Standard Treatment for Asthma and Rhinitis.
Intervention: Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis (Drug)
Outcomes
Primary Outcomes
Severity assessment of allergic rhinitis
Time Frame: Baseline 1 week before treatment; 2 follow-up every 12 months
The attending physician collects information on the patient's symptoms over the past four weeks, including sleep disturbances, limitations in daily activities such as leisure and exercise, limitations in learning, and symptoms (such as nasal itching, nasal congestion, runny nose, and sneezing) that did not cause significant discomfort. The physician then assesses the severity of the condition based on this information. Mild: None of the following are present: sleep disturbances, limitations on daily activities such as leisure/sports, learning limitations, and symptoms (itchy nose, nasal congestion, runny nose, sneezing) that do not cause distress. Moderate to Severe: One or more of the above symptoms are present.
EQ-5D-Y-3L for assessing health-related quality of life
Time Frame: Baseline 1 week before treatment; 2 follow-up every 12 months
The EQ-5D-Y-3L assesses HRQoL with five dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; and feeling worried, sad, or unhappy) and three severity levels. Each health state in the EQ-5D-Y-3L can be summarized using level descriptors, generating 243 (35) unique states. The best state, 11111, indicates 'no problems' in any dimension, while the worst state, 33333, indicates 'a lot of problems' in all dimensions. An index score of 1.0 represent the value of full health, and a score of 0.0 the value of death. Negative values represent health states with values below the value of death.
JRQLQ-No. 1 for assessing health-related quality of life in children with allergic rhinitis
Time Frame: Baseline 1 week before treatment; 2 follow-up every 12 months
The JRQLQ-No.1 questionnaire consists of 3 sections with a total of 24 items. Scoring: Calculate the average score for the first and second sections, then add the scores of all three sections and calculate the overall average score. Each item is scored on a scale, where higher scores indicate a better quality of life and lower scores indicate a worse quality of life. The minimum possible score is 1, indicating the worst outcome, and the maximum possible score is 7, indicating the best outcome.
PAQLQ for assessing health-related quality of life in children with asthma
Time Frame: Baseline 1 week before treatment; 2 follow-up every 12 months
The questionnaire includes symptoms (10 questions), activities (5 questions), and emotional functioning (8 questions), using a 7-point scale where 1 is the worst and 7 is the best. The total score is the sum of the scores for each dimension, with higher scores indicating better quality of life and lower scores indicating worse quality of life. A score greater than 66% of the total possible score indicates a high quality of life, 33%-66% indicates a moderate quality of life, and less than 33% indicates a low quality of life.
EQ-VAS for assessing health-related quality of life
Time Frame: Baseline 1 week before treatment; 2 follow-up every 12 months
A 20-cm visual analogue scale for overall health rating. Higher indicates better HRQoL.
Asthma control level for asthmatic children
Time Frame: Baseline 1 week before treatment; 2 follow-up every 12 months
The child or their parent recalls the frequency of asthma symptoms over the past four weeks, including daily activities, coughing, wheezing, use of asthma medications, and nighttime sleep. The attending physician collects this information during the consultation and assesses the severity of the condition. For individuals aged 12 and above, the Asthma Control Test (ACT) scores are interpreted as follows: a score of 25 or above indicates fully controlled asthma, 20-24 indicates well-controlled asthma, and 19 or below indicates uncontrolled asthma. For children aged 4 to 11, the Childhood Asthma Control Test (C-ACT) scores are interpreted similarly: a score of 24 or above indicates fully controlled asthma, 20-23 indicates well-controlled asthma, and 19 or below indicates uncontrolled asthma.
Secondary Outcomes
- Pulmonary function for assessing asthma disease severity(Baseline 1 week before treatment; 2 follow-up every 12 months)
- Peripheral Blood Eosinophils for assessing allergic severity(Baseline 1 week before treatment; 2 follow-up every 12 months)
Investigators
Wenjing Zhou
Principal Investigator
RenJi Hospital