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Completed

NCT Number: NCT03590639

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. IBD Disk's validity

    Time frame: changes from baseline IBD disk at 12 months

    Validity of the questionnaire

Secondary outcomes

  1. IBD Disk's 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)

    IBD Disk's reliability (Cronbach's coefficient alpha)

  2. IBD Disk's reproducibility

    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 (test-retest reliability)

  3. Satisfaction of the physician by Visual analog Scale

    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 feasibility (visual analog scale filled by the physician at the end of the study)

  4. Correlation between the IBD-Disk and the seriousness of the pathology

    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)

    the IBD-disk will be combined to the seriousness of the disease.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Rennes University Hospital
  • University Hospital, Angers

Registry information

Official study title

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

Acronym: VALIDate

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 18, 2018
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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