Development and Validation of a Self-reported Objective Index of Work Disability in Inflammatory Bowel Disease (IBD-OWDI)
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|ClinicalTrials.gov Identifier: NCT03872726|
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 14, 2019
Background theme Crohn's disease (CD) and ulcerative colitis (UC) are chronic diseases that alternate flares of active inflammation with periods of clinical remission. The working capacity of patients may be affected both by disease activity and by the aggressive treatment or surgical intervention required for the management of the disease and its complications. Work disability and impairment are especially important in patients with inflammatory bowel disease (IBD) because the disease affects young individuals who are generally employed and fully active.
Although there are several indexes in the literature that assess the degree of work disability due to IBD, all have a high degree of subjectivity, so none can be used to request disability pensions.
Experience of the research group on the subject Our group has developed a line of research on work disability associated with IBD.
Initially the investigators have studied the parameters that condition the granting of disability pensions of Spanish courts.
Subsequently, a population study of the prevalence of work disability in Spain has been carried out.
Finally, the investigators develop and validated a disability index for CD (published in its extensive and reduced form) and for UC (currently under review).
Hypothesis The IBD generates a work disability that can be measured objectively. Establishing the parameters related to disability is essential to promote equity in administrative and judicial decisions related to the granting of disability pensions to patients with IBD.
Objective Development and validation of an objective index to measure the degree of disability in IBD.
Material and methods:
A self-reported and objective questionnaire of disability will be developed based on the data of the population survey already carried out by our group.
Patients from a previous study (n 293) will be included. The relationship of different objective variables and disability outcomes will be analyzed with a univariate and a subsequent multivariate analysis. Alternative work disability scores will be developed.
Study 2: for the validation of the questionnaire a new online interview will be performed, patients from patients' assocations will be asked to participate. Data Collection: patients will answer a online survey administered with the SurveyMonkey © platform.
Participant will answer questions about demographics, disease activity, treatment and complications and data regarding disability. Patients will also complete the SCDWDQ (Short Crohn's Disease Work Disability Questionnaire), Work Productivity and Activity Index (WPAI), IBDQ-9, the EuroQol and IBD-DI (IBD disability index).
Statistical analysis: psychometric properties of the index will be evaluated:
- Convergent validity: the Spearman correlation will be used to correlate the objective disability score with IBD-DI and SCDWDQ.
- Discriminant validity: it will be measured by the t-test among patients with different degrees of disability (inactive-active, hospitalization-no hospitalization, surgery-no surgery).
|Condition or disease|
|Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease Disabling Disease Disability Physical|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Development and Validation of a Self-reported Objective Index of Work Disability in Inflammatory Bowel Disease|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||May 30, 2019|
- Development and validation of a self-reported objective index of disability in inflammatory bowel disease [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872726
|Sabadell, Barcelona, Spain, 08208|
|Contact: Luigi LM Melcarne, MD +34622567020 firstname.lastname@example.org|