Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory … (NCT04887428) | Clinical Trial Compass
CompletedNot Applicable
Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)
France343 participantsStarted 2019-11-28
Plain-language 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)
Who can participate
Age range
25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of active workers in employment
Timeframe: through study completion, an average of 18 months