Inflammatory Bowel DiseasesVALIDateNCT03590639
Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic (VALIDate)
An observational study of Inflammatory Bowel Diseases, run by Nantes University Hospital at 3 sites in France.
Trial summary
Inflammatory Bowel Diseases (IBD) often affect psychological, family, social and professional dimensions of patients' life, leading to disability which is essential to quantify as part of Patient-Reported Outcomes (PROs) newly included in the therapeutic targets to reach in IBD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 400 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Apr 2018to 16 Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted in 3 university hospitals (Nantes, Rennes, Angers) which use the IBD-Disk in their current practice. Investigators will offer patients with chronic inflammatory disease intestinal tract and seen in gastroenterological consultation during a control visit of their pathology to enter the study, regardless of previous or current treatments, with a goal to include 400 patients
Who may be able to join
- Patients of both sexes
- aged over 18 with an established diagnosis of IBD (Crohn's Disease, Ulcerative Colitis or IBD unclassified)
Who cannot join
- ongoing pregnancy or breast feeding woman
- vulnerable people i.e. Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard )
- insufficient command of French language and relevant psychiatric comorbidities (both of them making the self-questionnaire difficult to fill in)
- uncertain IBD diagnosis
Trial locations and contacts
3 sites in 1 country.
France3 sites
Angers University Hospital
Angers, 49100
Nantes University Hospital
Nantes, 44093
Rennes University Hospital
Rennes, 35033
About this study
Official title: IBD-Disk Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic
Inflammatory Bowel Diseases (IBD) often affect psychological, family, social and professional dimensions of patients' life, leading to disability which is essential to quantify as part of Patient-Reported Outcomes (PROs) newly included in the therapeutic targets to reach in IBD patients. Up to now, the IBD-Disability Index (IBD-DI) was the only validated tool to assess functional status, but it is not appropriate for use in clinical practice. The IBD Disk was then developed, a shortened and self-administered tool, adapted from the IBD-DI, in order to give immediate representation of patient-reported disability. However, the IBD Disk has not been validated yet in clinical practice. The aims of the VALIDate study is to validate this tool in a large population of French IBD patients and to compare it to the already validated IBD-DI.
Read the detailed description
The IBD-Disk has not been evaluated in clinical practice and has not yet been validated. but the interest of rapid assessment of the disease led the physicians in University Hospital of Nantes' department, some of whom had participated in the construction of this tool, to use it in routine practice for consultations of patients with IBD, joined by many gastroenterologists from other hospitals including the University Hospitals of Rennes and Angers.
The objective of this study is to validate this tool and prove its effectiveness by comparing it to the gold standard represented by the IBD-DI, in the same way that the PsoDisk has been validated prospectively compared to other tools for evaluating the quality of life and activity of psoriatic disease.
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Diseases, disability, quality of life, IBD Disk, IBD-Disability Index, Patient-Reported Outcomes
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
IBD Disk's validity
Validity of the questionnaire
Measured: changes from baseline IBD disk at 12 months
Secondary outcomes (4)
IBD Disk's reliability
IBD Disk's reliability (Cronbach's coefficient alpha)
Measured: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
IBD Disk's reproducibility
IBD Disk's reproducibility (test-retest reliability)
Measured: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
Satisfaction of the physician by Visual analog Scale
IBD Disk's feasibility (visual analog scale filled by the physician at the end of the study)
Measured: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
Correlation between the IBD-Disk and the seriousness of the pathology
the IBD-disk will be combined to the seriousness of the disease.
Measured: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start23 Apr 2018
- Primary completion9 Jul 2019
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers, Rennes University Hospital
- Responsible party
- Sponsor
- Investigators
- Caroline TRANG, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590639
- Sponsor's protocol ID
- RC18_0032
- Acronym
- VALIDate
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le Berre C, Bourreille A, Flamant M, Bouguen G, Siproudhis L, Dewitte M, Dib N, Cesbron-Metivier E, Goronflot T, Hanf M, Gourraud PA, Kerdreux E, Poinas A, Trang-Poisson C. Protocol of a multicentric prospective cohort study for the VALIDation of the IBD-disk instrument for assessing disability in inflammatory bowel diseases: the VALIDate study. BMC Gastroenterol. 2020 Apr 16;20(1):110. doi: 10.1186/s12876-020-01246-7.
PubMed 32299390
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IBD-Disk Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic
- ClinicalTrials.gov ID
- NCT03590639
- Acronym / sponsor ID
- VALIDate / RC18_0032
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Diseases, disability, quality of life, IBD Disk, IBD-Disability Index, Patient-Reported Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Angers, Rennes University Hospital
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 18 Jul 2018 (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.
Inflammatory Bowel Diseases (IBD) often affect psychological, family, social and professional dimensions of patients' life, leading to disability which is essential to quantify as part of Patient-Reported Outcomes (PROs) newly included in the therapeutic targets to reach in IBD patients. Up to now, the IBD-Disability Index (IBD-DI) was the only validated tool to assess functional status, but it is not appropriate for use in clinical practice. The IBD Disk was then developed, a shortened and self-administered tool, adapted from the IBD-DI, in order to give immediate representation of patient-reported disability. However, the IBD Disk has not been validated yet in clinical practice. The aims of the VALIDate study is to validate this tool in a large population of French IBD patients and to compare it to the already validated IBD-DI.
Detailed description
The IBD-Disk has not been evaluated in clinical practice and has not yet been validated. but the interest of rapid assessment of the disease led the physicians in University Hospital of Nantes' department, some of whom had participated in the construction of this tool, to use it in routine practice for consultations of patients with IBD, joined by many gastroenterologists from other hospitals including the University Hospitals of Rennes and Angers.
The objective of this study is to validate this tool and prove its effectiveness by comparing it to the gold standard represented by the IBD-DI, in the same way that the PsoDisk has been validated prospectively compared to other tools for evaluating the quality of life and activity of psoriatic disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in 3 university hospitals (Nantes, Rennes, Angers) which use the IBD-Disk in their current practice. Investigators will offer patients with chronic inflammatory disease intestinal tract and seen in gastroenterological consultation during a control visit of their pathology to enter the study, regardless of previous or current treatments, with a goal to include 400 patients
Key inclusion criteria (2 listed)
- Patients of both sexes
- aged over 18 with an established diagnosis of IBD (Crohn's Disease, Ulcerative Colitis or IBD unclassified)
Key exclusion criteria (4 listed)
- ongoing pregnancy or breast feeding woman
- vulnerable people i.e. Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard )
- insufficient command of French language and relevant psychiatric comorbidities (both of them making the self-questionnaire difficult to fill in)
- uncertain IBD diagnosis
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
IBD Disk's validity
Time frame: changes from baseline IBD disk at 12 months
Validity of the questionnaire
4 secondary outcomes
IBD Disk's reliability
Time frame: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
IBD Disk's reproducibility
Time frame: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
Satisfaction of the physician by Visual analog Scale
Time frame: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
Correlation between the IBD-Disk and the seriousness of the pathology
Time frame: Baseline and follow-up visit (between 3 and 12 months after baseline) for all of the outcome measures, except for reproducibility (7 days after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Derived from this study: PubMed 32299390Le Berre C, Bourreille A, Flamant M, Bouguen G, Siproudhis L, Dewitte M, Dib N, Cesbron-Metivier E, Goronflot T, Hanf M, Gourraud PA, Kerdreux E, Poinas A, Trang-Poisson C. Protocol of a multicentric prospective cohort study for the VALIDation of the IBD-disk instrument for assessing disability in inflammatory bowel diseases: the VALIDate study. BMC Gastroenterol. 2020 Apr 16;20(1):110. doi: 10.1186/s12876-020-01246-7.
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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.
Caroline TRANG, PH principal investigator
Nantes University Hospital
3 sites 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, run by Nantes University Hospital at 3 sites in France.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBD Disk's validity (time frame: changes from baseline IBD disk at 12 months). 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 NCT03590639, which also lists 1 linked publication.
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 22 Jul 2020.