Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)

NCT04881370 | Terminated

• 3 other identifiers: 2020_702020-A00464-35PRME-15-0464
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.

Conditions

Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Quality of life according to age and disease activity

  Quality of life is measured by EQ5D-5L questionnaire and transformed into utility according to French reference values

  through study completion, an average of 1 year

Secondary Outcomes (6)

• Correlation between EQ5D-5L and SIBDQ questionnaire in adults

  through study completion, an average of 1 year

• Correlation between EQ5D-5L and IMPACT III questionnaire in adolescents

  through study completion, an average of 1 year

• Quality of life according to previous surgery occurence

  through study completion, an average of 1 year

• Correlation between quality of life and perceived health

  through study completion, an average of 1 year

• Quality of life according to profession and academic degree (adults only)

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pediatric-onset IBD (diagnosed before the age of 17) and aged over 12 and under 25 at the time of the study.

You may qualify if:

• Male or female, between 12 and 24 years old included 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 ulcerative proctitis
• Disease diagnosed before the age of 17 (pediatric onset disease)
• Patient residing in the area of the EPIMAD register at the time of diagnosis: Nord, Pas-de-Calais, Somme or Seine-Maritime
• Patient not opposing the research
• Patient not having objected to the use of these data for ancillary studies when registering in the EPIMAD register

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

  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 3, 2021
• First Posted: May 11, 2021
• Study Start: October 9, 2020
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

FR (1)