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

NCT04887428 | Completed

• 2 other identifiers: 2017_192017-A03397-46
• Study Type: observational
• Target: 343
• Locations: 1 country
• Sites: 1

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:

• 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
• Evaluate the patient's feelings about the impact of his illness on occupational insertion and the educational level
• To describe the quality of life of patients in relation to disease activity and health states (QALY calculation)
• To assess the responsivness to change of the functional handicap score IBD-DI (n = 200 patients)

Conditions

Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Rate of active workers in employment

  Rate of active workers in employment collected using a standardized self-questionnaire

  through study completion, an average of 18 months

Secondary Outcomes (12)

• Educational level

  through study completion, an average of 18 months

• Association between occupational insertion and disease variables

  through study completion, an average of 18 months

• Association between occupational insertion and quality of life

  through study completion, an average of 18 months

• Association between educational level and disease variables

  through study completion, an average of 18 months

• Association between educational level and quality of life

  through study completion, an average of 18 months

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Dominique Turck, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: November 28, 2019
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

FR (1)