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

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.

Study Overview

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

Detailed Description

The continuous increase in incidence of chronic inflammatory bowel disease (IBD) will increase their burden on health care costs in the future. Pediatric IBD is frequently associated with an aggressive phenotype causing specific complications (undernutrition, pubertal delay or height-weight loss) and has a long-term impact on quality of life.

Therapeutic evolutions were marked in the 1990s by the arrival of immunosuppressants and then in the 2000s of biotherapies (anti-TNF).To limit the accumulation of tissue damage and to benefit from the maximum effectiveness of anti -TNF, clinicians are tempted to offer early treatment of CD with anti-TNF.

An ongoing study using data from the EPIMAD registry aims to study the impact of therapies on the disease course of patients with IBD in their childhood (Inspired study). This study also contains a medico-economic component, the objective of which is to evaluate the cost-effectiveness of the different management strategies for pediatric onset IBD. As part of this economic study, quality of life data will be needed. Indeed, there are very few data on quality of life in children / adolescents with IBD in the literature. These data must be collected from patients, unlike the other data used (retrospective data, in medical records).

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.

This study will supplement data currently being collected from patients over 25 years of age, quality of life being the subject of a secondary objective of a study on the professional integration of patients with IBD (PROMICI study , ID-RCB: 2017-A03397-46).

• Study Type: Observational
• Enrollment (Actual): 298

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• No exclusion criteria

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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between EQ5D-5L and SIBDQ questionnaire in adults	EQ5D-5L is a generic measure of quality of life and SIBDQ a disease-specific questionnaire of quality of life	through study completion, an average of 1 year
Correlation between EQ5D-5L and IMPACT III questionnaire in adolescents	EQ5D-5L is a generic measure of quality of life and IMPACT III a disease-specific questionnaire of quality of life	through study completion, an average of 1 year
Quality of life according to previous surgery occurence	Quality of life is measured by EQ5D-5L	through study completion, an average of 1 year
Correlation between quality of life and perceived health	Quality of life measured by EQ5D-5L and perceived health by Visual Analogue Scale	through study completion, an average of 1 year
Quality of life according to profession and academic degree (adults only)	Quality of life as measured by EQ5D-5L	through study completion, an average of 1 year
Quality of life according to profession and academic degree (adults only)	Quality of life as measured by SIBDQ	through study completion, an average of 1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Actual): June 28, 2021
• Study Completion (Actual): June 28, 2021

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 2020_70; 2020-A00464-35 (Other Identifier: ID-RCB number, ANSM); PRME-15-0464 (Other Identifier: DGOS number, PRME number)

Drug and device information, study documents

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