Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic (VALIDate) (VALIDate)

IBD-Disk Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • Angers University Hospital
  • Nantes, France, 44093
    • Nantes University Hospital
  • Rennes, France, 35033
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBD Disk's validity	Validity of the questionnaire	changes from baseline IBD disk at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBD Disk's reliability	IBD Disk's reliability (Cronbach's coefficient alpha)	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)
IBD Disk's reproducibility	IBD Disk's reproducibility (test-retest reliability)	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)
Satisfaction of the physician by Visual analog Scale	IBD Disk's feasibility (visual analog scale filled by the physician at the end of the study)	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)
Correlation between the IBD-Disk and the seriousness of the pathology	the IBD-disk will be combined to the seriousness of the disease.	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)

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: University Hospital, Angers; Rennes University Hospital
• Investigators: Principal Investigator: Caroline TRANG, PH, CHU de Nantes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): July 9, 2019
• Study Completion (Actual): April 16, 2020

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; disability; Inflammatory Bowel Diseases; IBD Disk; IBD-Disability Index; Patient-Reported Outcomes
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: RC18_0032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No