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Trial registered on ANZCTR


Registration number
ACTRN12613000903785
Ethics application status
Approved
Date submitted
30/07/2013
Date registered
13/08/2013
Date last updated
13/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective Validation Study of the International Classification of Functioning, Disability and Health Score in Crohn’s disease and ulcerative colitis.
Scientific title
IBD Disability Index Validation Study in patients with Crohn's disease or ulcerative colitis
Secondary ID [1] 282930 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel diseases 289745 0
Condition category
Condition code
Inflammatory and Immune System 290079 290079 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 290105 290105 0 0
Inflammatory bowel disease
Public Health 290106 290106 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Weeks
Description of intervention(s) / exposure
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.
Intervention code [1] 287628 0
Not applicable
Comparator / control treatment
Controls are non-IBD subjects, age- and sex-matched family members of hospital staff. They complete the same questionnaires as the intervention group at baseline only. Follow up is not required as they do not have IBD and do not flare.
Control group
Active

Outcomes
Primary outcome [1] 290127 0
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.
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.
Timepoint [1] 290127 0
Four weeks
Secondary outcome [1] 303983 0
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.
Timepoint [1] 303983 0
At baseline
Secondary outcome [2] 304013 0
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.
Timepoint [2] 304013 0
At baseline
Secondary outcome [3] 304014 0
Identifying predictors of employment status.
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.
Timepoint [3] 304014 0
At baseline

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
116 cases and 50 controls provide 80% power for 1 sided testing with alpha of 0.05 to identify 9% difference (eg 0 - 9%) of disability benefits. 9% being the rate of disability pension in a German population IBD cohort.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1361 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 1362 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 7225 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [2] 7226 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 287706 0
Hospital
Name [1] 287706 0
Concord Hospital
Address [1] 287706 0
Concord Hospital
IBD Service
Level 1 West
Hospital Rd
Concord NSW 2139
Country [1] 287706 0
Australia
Primary sponsor type
Hospital
Name
Concord Hospital
Address
Concord Hospital
IBD Service
Level 1 West
Hospital Rd
Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 286436 0
None
Name [1] 286436 0
Address [1] 286436 0
Country [1] 286436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289663 0
Concord Hospital
Ethics committee address [1] 289663 0
Concord Hospital
Level 1 West Concord Hospital
Hospital Rd
Concord NSW 2139
Ethics committee country [1] 289663 0
Australia
Date submitted for ethics approval [1] 289663 0
05/11/2010
Approval date [1] 289663 0
17/11/2010
Ethics approval number [1] 289663 0
HREC/10/CRGH/150

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41850 0
A/Prof Rupert Leong
Address 41850 0
Concord Hospital
Level 1 West
Hospital Rd
Concord NSW 2139
Country 41850 0
Australia
Phone 41850 0
+61297676111
Fax 41850 0
+61297676767
Email 41850 0
rupertleong@hotmail.com
Contact person for public queries
Name 41851 0
A/Prof Rupert Leong
Address 41851 0
Concord Hospital
Level 1 West
Hospital Rd
Concord NSW 2139
Country 41851 0
Australia
Phone 41851 0
61297676111
Fax 41851 0
Email 41851 0
rupertleong@hotmail.com
Contact person for scientific queries
Name 41852 0
A/Prof Rupert Leong
Address 41852 0
Concord Hospital
Level 1 West
Hospital Rd
Concord NSW 2139
Country 41852 0
Australia
Phone 41852 0
61297676111
Fax 41852 0
Email 41852 0
rupertleong@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary