Prospective Validation Study of the International Classification of Functioning, Disability and Health Score in Crohn’s disease and ulcerative colitis.

Not Applicable

Active, not recruiting

• Conditions: Inflammatory bowel diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders; Oral and Gastrointestinal - Inflammatory bowel disease; Public Health - Health service research

• Registration Number: ACTRN12613000903785
• Lead Sponsor: Concord Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Consecutive consenting ambulatory CD and UC patients were prospectively recruited from the IBD clinics of Concord and Bankstown Hospitals.
These are convenient cohorts that have a large range of severity of disabilities in order to test the full range of IBD disability.

Exclusion Criteria

Indeterminate colitis, microscopic colitis, infective enterocolitis. Unable to comprehend or complete the questionnaire, have an active psychiatric disorder, stoma, ileoanal pouch or significant symptomatic comorbidity that might affect function

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study was to design and validate a numerical scoring system for the IBD-DI to measure IBD disability using standard statistical techniques. <br>Patients will have nonparametric statistical validation studies on construct validity of the IBD-DI against CDAI, pMayo, IBDQ (Spearman correlation) along with Crohbachs alpha, intraclass correlation and reliability testing. Wilcoxon signed ranks test will be conducted to determine significance of median changes at 4 week follow up in those with and without flares of disease in between paired testing. [Four weeks]

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include identification of the extent of severe disability. Percentage of severe disability is defined as those with < - 30 IBD-DI scores within the cohort. <br> [At baseline];Correlation of disability with work absenteeism. The Work Productivity Assessment questionnaire will be used to correlate IBD-DI with hours of work absenteeism in the previous week to determine indirect cost of disability in terms of partial employment and unemployment. [At baseline];Identifying predictors of employment status. <br>Binary logistic regression is used to determine the predictive of unemployment - testing IBD-DI, IBDQ, medical and surgical treatment. This will be conducted using univariate tests selecting P<0.05 components and testing for multi-variate independent risk factors. [At baseline]