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

IBD Disability Index Validation Study in patients with Crohn's disease or ulcerative colitis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613000903785

Enrollment

162

Registered

2013-08-13

Start date

2013-01-05

Completion date

2013-07-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The central hypothesis is that the IBD-DI is an objective measure of disability in IBD that correlates with work absenteeism. 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. Secondary endpoints include identification of the extent of severe disability, correlation of disability with work absenteeism, and identifying predictors of employment status.

Interventions

This prospective face-to-face IBD ambulatory clinic cohort study measured IBD-DI, Crohn's Disease Activity Index (CDAI) for Crohn’s disease (CD) or partial Mayo score (pMayo) for ulcerative colitis (UC), IBDQ quality-of-life, and Work Productivity and Activity Impairment performed at baseline and at 4 weeks. Validation tests are performed and predictors and extent of work absenteeism are determined.

Eligibility

Sex/Gender

All

Age

16 Years to 80 Years

Healthy volunteers

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

Outcome results