Clinical trial NCT04881370: Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)
Official title: Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn Disease
Ulcerative Colitis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2021-05-11
Enrollment: 298
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pediatric-onset IBD (diagnosed before the age of 17) and aged over 12 and under 25 at the time of the study.

Brief 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.

Detailed 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).

Eligibility criteria: 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

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Quality of life according to age and disease activity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Correlation between EQ5D-5L and SIBDQ questionnaire in adults
timeFrame: through study completion, an average of 1 year
measure: Correlation between EQ5D-5L and IMPACT III questionnaire in adolescents
timeFrame: through study completion, an average of 1 year
measure: Quality of life according to previous surgery occurence
timeFrame: through study completion, an average of 1 year
measure: Correlation between quality of life and perceived health
timeFrame: through study completion, an average of 1 year
measure: Quality of life according to profession and academic degree (adults only)
timeFrame: through study completion, an average of 1 year
measure: Quality of life according to profession and academic degree (adults only)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Dominique TURCK
role: PRINCIPAL_INVESTIGATOR
References: