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Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD) — QALY-ECOPED  

Ulcerative Colitis Clinical Trial

Official title:
Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)

Clinical Trial Summary

The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.

Clinical Trial Description

The continuous increase in incidence of chronic inflammatory bowel disease (IBD) will increase their burden on health care costs in the future. Pediatric IBD is frequently associated with an aggressive phenotype causing specific complications (undernutrition, pubertal delay or height-weight loss) and has a long-term impact on quality of life. Therapeutic evolutions were marked in the 1990s by the arrival of immunosuppressants and then in the 2000s of biotherapies (anti-TNF).To limit the accumulation of tissue damage and to benefit from the maximum effectiveness of anti -TNF, clinicians are tempted to offer early treatment of CD with anti-TNF. An ongoing study using data from the EPIMAD registry aims to study the impact of therapies on the disease course of patients with IBD in their childhood (Inspired study). This study also contains a medico-economic component, the objective of which is to evaluate the cost-effectiveness of the different management strategies for pediatric onset IBD. As part of this economic study, quality of life data will be needed. Indeed, there are very few data on quality of life in children / adolescents with IBD in the literature. These data must be collected from patients, unlike the other data used (retrospective data, in medical records). The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models. This study will supplement data currently being collected from patients over 25 years of age, quality of life being the subject of a secondary objective of a study on the professional integration of patients with IBD (PROMICI study , ID-RCB: 2017-A03397-46). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04881370
Study type Observational
Source University Hospital, Lille
Contact
Status Terminated
Phase
Start date October 9, 2020
Completion date June 28, 2021
View Details
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