CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children
1 other identifier
observational
113
1 country
1
Brief Summary
This project is an observational study for the Italian language validation of the CARATKids questionnaire investigating the asthma and coexisting allergic rhinitis control in children. 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy. The study will be completed in two medical examination, within 3-6 weeks of each other. CARATKids questionnaire, VAS (Visual Analogic Scale) and C-ACT (Children Asthma Control Test) will be filled by each patient. The main outcome is the Italian language validation of the CARATKids questionnaire investigating the coexisting asthma and allergic rhinitis control in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJuly 15, 2016
July 1, 2016
1.3 years
March 24, 2015
July 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CARATKids Italian language validation
The main objective of the study is the assessment process of the tool CARATKids, in a scholastic children Italian population affected by coexisting asthma and allergic rhinitis.
3 weeks
Study Arms (1)
113 patients with concomitant asthma and allergic rhinitis
113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.
Interventions
Eligibility Criteria
113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.
You may qualify if:
- patients with concomitant asthma and allergic rhinitis followed up from at least 3 months
- \< years old \> 6
You may not qualify if:
- Patients with asthma only or allergic rhinitis only, or younger or older than the targeted age group
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Biomedicine and Molecular Immunology, IBIM
Palermo, Palermo, 90146, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Study Record Dates
First Submitted
March 24, 2015
First Posted
April 7, 2015
Study Start
April 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
July 15, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share
The IPD collected will be available on May 2016. The following participant data will be shared: * Asthma severity level * Asthma control level * Pulmonary function tests * Demographic characteristics All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.