Clinical trial NCT03590639: Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic (VALIDate)
Official title: IBD-Disk Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Inflammatory Bowel Diseases
disability
quality of life
IBD Disk
IBD-Disability Index
Patient-Reported Outcomes
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
name: Rennes University Hospital
First posted: 2018-07-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted in 3 university hospitals (Nantes, Rennes, Angers) which use the IBD-Disk in their current practice.

Investigators will offer patients with chronic inflammatory disease intestinal tract and seen in gastroenterological consultation during a control visit of their pathology to enter the study, regardless of previous or current treatments, with a goal to include 400 patients

Brief summary: Inflammatory Bowel Diseases (IBD) often affect psychological, family, social and professional dimensions of patients' life, leading to disability which is essential to quantify as part of Patient-Reported Outcomes (PROs) newly included in the therapeutic targets to reach in IBD patients. Up to now, the IBD-Disability Index (IBD-DI) was the only validated tool to assess functional status, but it is not appropriate for use in clinical practice. The IBD Disk was then developed, a shortened and self-administered tool, adapted from the IBD-DI, in order to give immediate representation of patient-reported disability. However, the IBD Disk has not been validated yet in clinical practice. The aims of the VALIDate study is to validate this tool in a large population of French IBD patients and to compare it to the already validated IBD-DI.

Detailed description: The IBD-Disk has not been evaluated in clinical practice and has not yet been validated. but the interest of rapid assessment of the disease led the physicians in University Hospital of Nantes' department, some of whom had participated in the construction of this tool, to use it in routine practice for consultations of patients with IBD, joined by many gastroenterologists from other hospitals including the University Hospitals of Rennes and Angers.

The objective of this study is to validate this tool and prove its effectiveness by comparing it to the gold standard represented by the IBD-DI, in the same way that the PsoDisk has been validated prospectively compared to other tools for evaluating the quality of life and activity of psoriatic disease.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes
* aged over 18 with an established diagnosis of IBD (Crohn's Disease, Ulcerative Colitis or IBD unclassified)

Exclusion Criteria:

* ongoing pregnancy or breast feeding woman
* vulnerable people i.e. Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard )
* insufficient command of French language and relevant psychiatric comorbidities (both of them making the self-questionnaire difficult to fill in)
* uncertain IBD diagnosis

Primary outcomes:
measure: IBD Disk's validity
timeFrame: changes from baseline IBD disk at 12 months
Secondary outcomes:
measure: IBD Disk's reliability
timeFrame: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
measure: IBD Disk's reproducibility
timeFrame: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
measure: Satisfaction of the physician by Visual analog Scale
timeFrame: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
measure: Correlation between the IBD-Disk and the seriousness of the pathology
timeFrame: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Caroline TRANG, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Berre C, Bourreille A, Flamant M, Bouguen G, Siproudhis L, Dewitte M, Dib N, Cesbron-Metivier E, Goronflot T, Hanf M, Gourraud PA, Kerdreux E, Poinas A, Trang-Poisson C. Protocol of a multicentric prospective cohort study for the VALIDation of the IBD-disk instrument for assessing disability in inflammatory bowel diseases: the VALIDate study. BMC Gastroenterol. 2020 Apr 16;20(1):110. doi: 10.1186/s12876-020-01246-7.