Development and Validation of a Self-reported Objective Index of Work Disability in Inflammatory Bowel Disease (IBD-OWDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03872726

Recruitment Status : Unknown

Verified March 2019 by Luigi Melcarne, Corporacion Parc Tauli.
Recruitment status was: Recruiting

First Posted : March 13, 2019

Last Update Posted : March 14, 2019

Sponsor:

Information provided by (Responsible Party):

Luigi Melcarne, Corporacion Parc Tauli

Study Description

Brief Summary:

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:

Study 1:

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 Design

Layout table for study information

Study Type :	Observational [Patient Registry]
Estimated Enrollment :	800 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Ulcerative colitis Crohn disease

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Development and validation of a self-reported objective index of disability in inflammatory bowel disease [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

A cross-sectional observational epidemiological study will be developed by administering a survey to a large population (on a national scale in Spain) of patients with IBD occupationally active.

Patients will be asked to complete an online survey using a form written with the SurveyMonkey © platform.

For the validation we included more than 500 patients equally divided between CU and EC.

Criteria

Inclusion Criteria:

Patients between 18 and 65 years old.
Labor assets or temporary sick leave.
Diagnosis of IBD in the 6 months prior to the survey

Exclusion Criteria:

Inability to understand or fill out the questionnaires.
Refusal to participate in the study.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

Layout table for location information

Spain
Luigi Melcarne	Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Luigi LM Melcarne, MD +34622567020 lmelcarne@tauli.cat

Sponsors and Collaborators

Corporacion Parc Tauli

More Information

Additional Information:

Publications of Results:

Calvet X, Gallardo O, Coronas R, Casellas F, Montserrat A, Torrejón A, Vergara M, Campo R, Brullet E. Remission on thiopurinic immunomodulators normalizes quality of life and psychological status in patients with Crohn's disease. Inflamm Bowel Dis. 2006 Aug;12(8):692-6.

Other Publications:

Calvet X, Motos J, Montserrat A, Gallardo O, Vergara M. Analysis of court criteria for awarding disability benefits to patients with Crohn's disease. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1322-7. doi: 10.1016/j.cgh.2009.01.015. Epub 2009 Feb 4.

Vergara M, Montserrat A, Casellas F, Villoria A, Suarez D, Maudsley M, Gallardo O, Ricart E, Calvet X. A new validation of the Spanish Work Productivity and Activity Impairment Questionnaire-Crohn's disease version. Value Health. 2011 Sep-Oct;14(6):859-61. doi: 10.1016/j.jval.2011.02.1179. Epub 2011 May 28.

Vergara M, Montserrat A, Casellas F, Maudsley M, Gallardo O, Ricart E, Calvet X. Validation of the Spanish Work Productivity and Activity impairment questionnaire: Crohn's disease version. Eur J Gastroenterol Hepatol. 2009 Jul;21(7):809-15. doi: 10.1097/MEG.0b013e32830f4c9e.

Ramos A, Calvet X, Sicilia B, Vergara M, Figuerola A, Motos J, Sastre A, Villoria A, Gomollón F. IBD-related work disability in the community: Prevalence, severity and predictive factors. A cross-sectional study. United European Gastroenterol J. 2015 Aug;3(4):335-42. doi: 10.1177/2050640615577532.

Vergara M, Sicilia B, Prieto L, Casellas F, Ramos A, Gomollón F, Calvet X. Development and Validation of the Short Crohn's Disease Work Disability Questionnaire. Inflamm Bowel Dis. 2016 Apr;22(4):955-62. doi: 10.1097/MIB.0000000000000678.

Ramos A, Vergara M, Melcarne L, Sicilia B, Gomollón F, Calvet X. Validation of a self-reported work disability questionnaire for ulcerative colitis. Medicine (Baltimore). 2018 Sep;97(39):e12486. doi: 10.1097/MD.0000000000012486.

Layout table for additonal information

Responsible Party:	Luigi Melcarne, Principal Investigator, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:	NCT03872726
Other Study ID Numbers:	Ref.: 2019/523
First Posted:	March 13, 2019 Key Record Dates
Last Update Posted:	March 14, 2019
Last Verified:	March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Luigi Melcarne, Corporacion Parc Tauli:


disability Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease

Additional relevant MeSH terms:

Layout table for MeSH terms

Crohn Disease Colitis Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases Ulcer	Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes

To Top