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

NCT03590639 | Completed

• 1 other identifier: RC18_0032
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Inflammatory Bowel Diseases; disability; quality of life; IBD Disk; IBD-Disability Index; Patient-Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• IBD Disk's validity

  Validity of the questionnaire

  changes from baseline IBD disk at 12 months

Secondary Outcomes (4)

• IBD Disk's 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)

• IBD Disk's reproducibility

  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

  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

  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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients of both sexes
• aged over 18 with an established diagnosis of IBD (Crohn's Disease, Ulcerative Colitis or IBD unclassified)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• University Hospital, Angers: collaborator
• Rennes University Hospital: collaborator

Study Sites (3)

Angers University Hospital

Angers, 49100, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

Related Publications (1)

• 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.

  PMID: 32299390 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Caroline TRANG, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 18, 2018
• Study Start: April 23, 2018
• Primary Completion: July 9, 2019
• Study Completion: April 16, 2020
• Last Updated: July 22, 2020

Record last verified: 2018-06

Locations

FR (3)