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

NCT03590639 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2020-07-22

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Sponsors & Collaborators

  • University Hospital, Angers

    collaborator OTHER_GOV

  • Rennes University Hospital

    collaborator OTHER

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Caroline TRANG, PH · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2019-07-09
Completion
2020-04-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03590639 on ClinicalTrials.gov