Validation in French of a Quality of Life Questionnaire for Patients With Eosinophilic Esophagitis in Pediatrics
ValidEoE
1 other identifier
observational
100
1 country
1
Brief Summary
Eosinophilic esophagitis is a chronic condition of the esophagus. The symptoms of eosinophilic esophagitis can affect the quality of life of affected children. There is no French scale to specifically evaluate the quality of life of these patients. It will be a monocentric, prospective, descriptive study carried out at the Nice University Pédiatric Hospital. The main objective of this study will be the validation of a French version of the quality of life pediatric scale (PedsQL) module for eosinophilic esophagitis. It will take place in 2 distinct parts:
- The translation of the questionnaire in French.
- Collection of the quality of life questionnaires
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 Jul 2023
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
June 2, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2023
CompletedStudy Start
First participant enrolled
July 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedSeptember 29, 2023
September 1, 2023
12 months
June 2, 2023
September 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Measure of quality of life
Validation of a French and cross-cultural version of the quality of life scale for eosinophilic esophagitis in pediatrics (PedsQL) The PedsQL eosinophilic eosophagitis module is divided into several forms, each corresponding to different age groups with questions adapted according to age. (2-4 years, 5-7 years, 8-12 years and 13-18 years). This questionnaire is intended for children and their parents. The total score is the sum of the 35 items for 8-17 year olds, 22 for 2-4 year olds, 27 for 5-7 year olds. The maximum score is 175 for 8-17 year olds, 110 for 2-4 year olds, 135 for 5-7 year olds. The higher the score, the greater the impact of eosinophilic esophagitis on the patient's life.
at inclusion
Secondary Outcomes (1)
reliability of the interviewer
through study completion, an average of 1 year
Study Arms (1)
Patients in the pediatric population with eosinophilic eosphagitis
Patients in the pediatric population with eosinophilic eosiphagitis responding to the PedsQL eosinophilic eosophagitis module
Interventions
Measurement of the quality of life of patients with eosinophilic esophagitis by the PedsQL questionnaire eosinophilic esophagitis module
Eligibility Criteria
Patients in the pediatric population with eosinophilic eosiphagitis responding to the PedsQL eosinophilic eosophagitis module and their parents
You may qualify if:
- For children :
- Patients followed at Nice-Lenval University Hospital in pediatric gastroenterology between July 2022 and July 2023
- Age between 2 and 17 years old
- Obligation for all patients to be affiliated to social security system
- Patient followed for eosinophilic esophagitis. Diagnostic criteria for EoE ( compatible symptoms and histological involvement on at least two different esophageal levels: presence of infiltration of the esophageal mucosa greater than 15 eosinophils per field)
- Acceptance of participation in the study
- For parents or representative of parental authority:
- Parents or representative of parental authority, of a child followed at Lenval Hospital in pediatric gastroenterology for eosinophilic esophagitis
- Affiliated to a social security system
- Acceptance of participation in the study
You may not qualify if:
- Intellectual disability, cognitive inability to complete the questionnaire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondation Lenvallead
Study Sites (1)
Hopitaux Pediatriques de Nice Chu-Lenval
Nice, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2023
First Posted
June 12, 2023
Study Start
July 17, 2023
Primary Completion
July 1, 2024
Study Completion
December 1, 2024
Last Updated
September 29, 2023
Record last verified: 2023-09