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

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)

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Ulcerative Colitis

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.

• Study Type: Observational
• Enrollment (Actual): 343

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Educational level	Description of educational level collected using a standardized self-administered questionnaire	through study completion, an average of 18 months
Association between occupational insertion and disease variables	Associated factors are : disease type (Crohn / Ulcerative colitis), gender, location of the disease at diagnosis, surgery, treatments, age at diagnosis	through study completion, an average of 18 months
Association between occupational insertion and quality of life	Quality of life as measured by SIBDQ questionnaire.	through study completion, an average of 18 months
Association between educational level and disease variables	Associated factors are : disease type (Crohn / Ulcerative colitis), gender, location of the disease at diagnosis, surgery, treatments, age at diagnosis	through study completion, an average of 18 months
Association between educational level and quality of life	Quality of life as measured by SIBDQ questionnaire.	through study completion, an average of 18 months
Percentage of patients for whom the disease had an influence on the choice of studies	This question is directly asked to the patient and reflects its own feeling	through study completion, an average of 18 months
Percentage of patients for whom the disease had an influence on the course of the studies	This question is directly asked to the patient and reflects its own feeling	through study completion, an average of 18 months
Percentage of patients for whom the disease had an influence on the choice of profession	This question is directly asked to the patient and reflects its own feeling	through study completion, an average of 18 months
Quality of life as measured by EQ5D-5L questionnaire	Quality of life as measured by EQ5D-5L questionnaire and transformed into utility according to French reference values. Quality of life will be described according to age, disease activity and surgery.	through study completion, an average of 18 months
Disease activity for Crohn's patients	As measured by HBI (Harvey-Bradshaw Index). Disease activity will be used to describe quality of life according to disease state and to assessed sensitivity to change of IBD-Disability Index.	through study completion, an average of 18 months
Disease activity for Ulcerative Colitis patients	As measured by SCCAI questionnaire (Simple Clinical Colitis Activity Index). Disease activity will be used to describe quality of life according to disease state and to assessed sensitivity to change of IBD-Disability Index.	through study completion, an average of 18 months
Disability in 200 patients	As measured by IBD-DI (IBD Disability Index) in 200 patients previously questioned in 2012 in order to address the question of sensitivity to change of IBD-DI. Measure of change is disease activity as measured by HBI-Index for Crohn's patients and SCCAI for Ulcerative Colitis patients.	through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Dominique Turck, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2019
• Primary Completion (Actual): January 28, 2023
• Study Completion (Actual): January 28, 2023

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: 2017_19; 2017-A03397-46 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No