Inflammatory Bowel DiseasesIBD-OWDINCT03872726
Development and Validation of a Self-reported Objective Index of Work Disability in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- How many people
- 800 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 30 May 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients between 18 and 65 years old.
- Labor assets or temporary sick leave.
- Diagnosis of IBD in the 6 months prior to the survey
Who cannot join
- Inability to understand or fill out the questionnaires.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Luigi Melcarne
Sabadell, Barcelona, 08208
Luigi LM Melcarne, MD, +34622567020, lmelcarne@tauli.cat
About this study
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.
Read more
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).
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, Disabling Disease, Disability Physical
- Keywords
- disability, Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and validation of a self-reported objective index of disability in inflammatory bowel disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Mar 2019
- Primary completion30 May 2019 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Melcarne, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872726
- Sponsor's protocol ID
- Ref.: 2019/523
- Acronym
- IBD-OWDI
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19558989Vergara 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.
PubMed 21914506Vergara 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.
PubMed 19404204Ramos A, Calvet X, Sicilia B, Vergara M, Figuerola A, Motos J, Sastre A, Villoria A, Gomollon 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.
PubMed 26279841Vergara M, Sicilia B, Prieto L, Casellas F, Ramos A, Gomollon 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.
PubMed 26933747Ramos A, Vergara M, Melcarne L, Sicilia B, Gomollon 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.
PubMed 30278537Calvet X, Gallardo O, Coronas R, Casellas F, Montserrat A, Torrejon 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. doi: 10.1097/00054725-200608000-00004.
PubMed 16917223
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Self-reported Objective Index of Work Disability in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03872726
- Acronym / sponsor ID
- IBD-OWDI / Ref.: 2019/523
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, Disabling Disease, Disability Physical
- Keywords
- disability, Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients between 18 and 65 years old.
- Labor assets or temporary sick leave.
- Diagnosis of IBD in the 6 months prior to the survey
Key exclusion criteria (2 listed)
- Inability to understand or fill out the questionnaires.
- Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development and validation of a self-reported objective index of disability in inflammatory bowel disease
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Background: PubMed 19558989Calvet 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.
- Background: PubMed 21914506Vergara 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.
- Background: PubMed 19404204Vergara 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.
- Background: PubMed 26279841Ramos A, Calvet X, Sicilia B, Vergara M, Figuerola A, Motos J, Sastre A, Villoria A, Gomollon 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.
- Background: PubMed 26933747Vergara M, Sicilia B, Prieto L, Casellas F, Ramos A, Gomollon 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.
- Background: PubMed 30278537Ramos A, Vergara M, Melcarne L, Sicilia B, Gomollon 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.
- Results publication: PubMed 16917223Calvet X, Gallardo O, Coronas R, Casellas F, Montserrat A, Torrejon 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. doi: 10.1097/00054725-200608000-00004.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and validation of a self-reported objective index of disability in inflammatory bowel disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872726, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.