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.
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
400
Angers University Hospital
Angers, France
Nantes University Hospital
Nantes, France
Rennes University Hospital
Rennes, France
IBD Disk's validity
Validity of the questionnaire
Time frame: changes from baseline IBD disk at 12 months
IBD Disk's reliability
IBD Disk's reliability (Cronbach's coefficient alpha)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.