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| Name | Class |
|---|---|
| University of Western Ontario, Canada | OTHER |
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
| The Cleveland Clinic | OTHER |
| OPEN Health (Pharmerit) |
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To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments. To allow this patient population to be included in clinical trials, outcome and measurement tools are needed. This study aims to develop a Patient Reported Outcome (PRO) and Endoscopic Index (EI) for patients with Crohn's Disease (CD) and permanent ileostomy. The study will enroll about 50 participants and collect videos of endoscopies that are done as part of standard of care. The videos will be centrally read to identify features that represent a broad range of inflammation and will be used to develop the EI. Participants will also be asked to participate in interviews, to understand the symptoms and impacts that are most important to participants for the development of a PRO.
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| Measure | Description | Time Frame |
|---|---|---|
| Develop a PRO instrument for patients with Crohn's Disease and Permanent Ileostomy | Concept elicitation interviews focusing on the symptoms and impacts relevant to patients with CD and permanent ileostomy will be conducted and used to develop a PRO. Cognitive interviews will subsequently be conducted to determine respondent comprehension and relevance of the items. | through study completion, and average of 1 year |
| Evaluate the intrarater reliability of 100-mm VAS. | Central readers will score endoscopy videos using the VAS, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data. | At baseline and 2 weeks |
| Evaluate the intrarater reliability of RAM identified items. | Central readers will score endoscopy videos for items identified during a RAND/UCLA appropriateness method, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data. | At baseline and 2 weeks |
| Evaluate the intrarater reliability of Rutgeerts score and its component items. | Central readers will score endoscopy videos using the Rutgeerts Score, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data. | At baseline and 2 weeks |
| Evaluate the intrarater reliability of CDEIS and its component items. | Central readers will score endoscopy videos using the CDEIS, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data. |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 50 participants who meet the inclusion and exclusion criteria will be enrolled in the study. The study population will ideally include approximately equal distributions of participants with disease activity categorized by a central reader as normal, mild, moderate, and severe, according to the VAS assessment. It is not possible to predetermine the number of participants with specific disease activity levels. The distribution of inflammatory disease activity across the study population will be monitored on an ongoing basis and recruitment strategies may be reviewed for opportunities to help maintain a balanced distribution. No more than 10 asymptomatic participants will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Olteanu | Contact | 416-704-7734 | ana.olteanu@alimentiv.com | |
| Robyn Garrels-Lierman | Contact | 642-204-2047 | robyn.garrels@alimentiv.com |
| Name | Affiliation | Role |
|---|---|---|
| Florian Rieder | The Cleveland Clinic | Principal Investigator |
| Vipul Jairath | Western University, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic- Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| UNKNOWN |
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Participants enrolled in this study will be invited to donate biopsy samples, serum, and/or stool to the Cleveland Clinic Foundation Gastrointestinal Research Biobank. The provision of these samples is optional and not required for this study. The samples and corresponding deidentified data collected for this study will be transferred to the Cleveland Clinic, where they will be processed, stored, and analyzed for future research purposes not related to this study, including investigation of aspects of IBD that may lead to improved treatments and management strategies for individuals affected by IBD.
| At baseline and 2 weeks |
| Evaluate the intrarater reliability of SES-CD and its component items. | Central readers will score endoscopy videos using the SES-CD, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data. | At baseline and 2 weeks |
| Evaluate the interrater reliability of 100-mm VAS. | Central readers will score endoscopy videos using the VAS, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data. | At baseline |
| Evaluate the interrater reliability of RAM identified items. | Central readers will score endoscopy videos for items identified during a RAND/UCLA appropriateness method, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data. | At baseline |
| Evaluate the interrater reliability of Rutgeerts score and its component items. | Central readers will score endoscopy videos using the Rutgeerts score, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data. | At baseline |
| Evaluate the interrater reliability of CDEIS and its component items. | Central readers will score endoscopy videos using the CDEIS, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data. | At baseline |
| Evaluate the interrater reliability of SES-CD and its component items. | Central readers will score endoscopy videos using the SES-CD, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data. | At baseline |
| Develop a novel index using a multiple regression approach with the dependent variables being the VAS and candidate independent variables including items having at least moderate interrater reliability. | A prototype index will be created using the VAS for global assessment of severity as the dependent criterion. Prospective validation of the endoscopic index will be performed in a future initiative outside of the scope of this study. | through study completion, and average of 1 year |
| Washington University in St Louis School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| McMaster University Medical Centre | Recruiting | Hamilton | Ontario | L6S 0E2 | Canada |
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| LHSC - University Campus | Recruiting | London | Ontario | L6S 0E2 | Canada |
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| D007410 | Intestinal Diseases |