Skip to main content
OpenTrials
Completed

NCT Number: NCT04887428

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Crohn Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of active workers in employment

    Time frame: through study completion, an average of 18 months

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

Secondary outcomes

  1. Educational level

    Time frame: through study completion, an average of 18 months

    Description of educational level collected using a standardized self-administered questionnaire

  2. Association between occupational insertion and disease variables

    Time frame: through study completion, an average of 18 months

    Associated factors are : disease type (Crohn / Ulcerative colitis), gender, location of the disease at diagnosis, surgery, treatments, age at diagnosis

  3. Association between occupational insertion and quality of life

    Time frame: through study completion, an average of 18 months

    Quality of life as measured by SIBDQ questionnaire.

  4. Association between educational level and disease variables

    Time frame: through study completion, an average of 18 months

    Associated factors are : disease type (Crohn / Ulcerative colitis), gender, location of the disease at diagnosis, surgery, treatments, age at diagnosis

  5. Association between educational level and quality of life

    Time frame: through study completion, an average of 18 months

    Quality of life as measured by SIBDQ questionnaire.

  6. Percentage of patients for whom the disease had an influence on the choice of studies

    Time frame: through study completion, an average of 18 months

    This question is directly asked to the patient and reflects its own feeling

  7. Percentage of patients for whom the disease had an influence on the course of the studies

    Time frame: through study completion, an average of 18 months

    This question is directly asked to the patient and reflects its own feeling

  8. Percentage of patients for whom the disease had an influence on the choice of profession

    Time frame: through study completion, an average of 18 months

    This question is directly asked to the patient and reflects its own feeling

  9. Quality of life as measured by EQ5D-5L questionnaire

    Time frame: through study completion, an average of 18 months

    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.

  10. Disease activity for Crohn's patients

    Time frame: through study completion, an average of 18 months

    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.

  11. Disease activity for Ulcerative Colitis patients

    Time frame: through study completion, an average of 18 months

    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.

  12. Disability in 200 patients

    Time frame: through study completion, an average of 18 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: PROMICI

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 14, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.