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

Ulcerative Colitis Clinical Trial

— QALY-ECOPED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04881370
• Other study ID #: 2020_70
• Secondary ID: 2020-A00464-35PR
• Status: Terminated
• Start date: October 9, 2020
• Est. completion date: June 28, 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 298
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Quality of life according to previous surgery occurence	Quality of life is measured by EQ5D-5L	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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