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

Inflammatory Bowel Diseases Clinical Trial

— VALIDate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590639
• Other study ID #: RC18_0032
• Status: Completed
• Start date: April 23, 2018
• Est. completion date: April 16, 2020

Study information

• Verified date: June 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 16, 2020
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Nantes University Hospital	Nantes
France	Rennes University Hospital	Rennes

Sponsors (3)

Lead Sponsor	Collaborator
Nantes University Hospital	Rennes University Hospital, University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBD Disk's validity	Validity of the questionnaire	changes from baseline IBD disk at 12 months
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)