Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)

NCT ID: NCT04887428

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 460 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2026-01-31

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.

Conditions

Crohn Disease; Ulcerative Colitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique Turck, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Dominique Turck, MD,PhD

Role: CONTACT

Phone: 320446885

Email: Dominique.Turck@CHRU-Lille.fr

Facility Contacts

Role: primary

Other Identifiers

2017-A03397-46

Identifier Type: OTHER

Identifier Source: secondary_id

2017_19

Identifier Type: -

Identifier Source: org_study_id