Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535087
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
The Impact of Airway Allergic Diseases on Childrens and Parents Quality of Life
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-YEuroQol 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 childrens 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 FeNOFractional 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 oralnasal 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 Fishers 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
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 childrens 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 FeNOFractional 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 oralnasal 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 Fishers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None