Clinical trial NCT04887428: Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)
Official title: Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Ulcerative Colitis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2021-05-14
Enrollment: 460
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 25 at the time of the study.

Brief summary: The main objective of this project is to assess the occupational insertion of these adult patients with pediatric-onset IBD and to compare it with the general population.

The secondary objectives are:

1. to assess the level of education and compare it to that of the general population
2. to assess occupational insertion and the educational level according to:

   * The disease (Crohn's disease, ulcerative colitis or unclassified colitis)
   * sex
   * Age at diagnosis (\<or ≥ 10 years)
   * The occurence of surgery, the location of the disease, the treatments undertaken
   * Quality of life
3. Evaluate the patient's feelings about the impact of his illness on occupational insertion and the educational level
4. To describe the quality of life of patients in relation to disease activity and health states (QALY calculation)
5. To assess the responsivness to change of the functional handicap score IBD-DI (n = 200 patients)

Detailed description: Chronic inflammatory bowel diseases (IBD) are responsible for high morbidity and impaired quality of life of patients throughout disease course.

Numerous studies have shown the impact of the disease on the quality of life of patients with IBD. However, very little data is available on the level of education and professional integration of patients who started their IBD in childhood.

The hypothesis behind the study project is that the level of education and consequently the professional integration of patients with early pediatric IBD: 1) could be different from those of the general population; 2) and that these differences could be influenced by the nature of IBD, the age of its onset and its main characteristics.

The main objective of this project is to assess the professional integration of these adult patients with pediatric-onset IBD and to compare it with the general population.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 25 and over 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 ulcerated proctitis, unclassified colitis, diagnosed between 01/01 / 1988 and 12/31/2011, with an age at diagnosis of less than 17 years (definition of the pediatric cohort of the EPIMAD Registry)
* Patient residing in the area of the EPIMAD registry: Nord, Pas-de-Calais, Somme or Seine-Maritime
* Patient not opposed to the research
* Patient not having objected to the use of their data for ancillary studies when registering in the EPIMAD register

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of active workers in employment
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
measure: Educational level
timeFrame: through study completion, an average of 18 months
measure: Association between occupational insertion and disease variables
timeFrame: through study completion, an average of 18 months
measure: Association between occupational insertion and quality of life
timeFrame: through study completion, an average of 18 months
measure: Association between educational level and disease variables
timeFrame: through study completion, an average of 18 months
measure: Association between educational level and quality of life
timeFrame: through study completion, an average of 18 months
measure: Percentage of patients for whom the disease had an influence on the choice of studies
timeFrame: through study completion, an average of 18 months
measure: Percentage of patients for whom the disease had an influence on the course of the studies
timeFrame: through study completion, an average of 18 months
measure: Percentage of patients for whom the disease had an influence on the choice of profession
timeFrame: through study completion, an average of 18 months
measure: Quality of life as measured by EQ5D-5L questionnaire
timeFrame: through study completion, an average of 18 months
measure: Disease activity for Crohn's patients
timeFrame: through study completion, an average of 18 months
measure: Disease activity for Ulcerative Colitis patients
timeFrame: through study completion, an average of 18 months
measure: Disability in 200 patients
timeFrame: through study completion, an average of 18 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Dominique Turck, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: