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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-09

Study Completion Date

2021-06-28

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Crohn Disease Ulcerative Colitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Male or female, between 12 and 24 years old included at the time of the study
* Subject listed in the EPIMAD registry suffering from certain or probable Crohn's disease, or certain or probable ulcerative colitis, or certain or probable ulcerative proctitis
* Disease diagnosed before the age of 17 (pediatric onset disease)
* Patient residing in the area of the EPIMAD register at the time of diagnosis: Nord, Pas-de-Calais, Somme or Seine-Maritime
* Patient not opposing the research
* Patient not having objected to the use of these data for ancillary studies when registering in the EPIMAD register

Minimum Eligible Age

12 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No