A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)

Study Overview
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Brief Summary
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The descriptive purpose of this study is to characterize clinical and nonclinical factors of participants with CD, participant flow and visits to other specialists in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of electronic medical records. The clinical and nonclinical factors include: demographic and baseline clinical characteristics, lifestyle, relapses, complications, day hospital visits, surgery, presence of complications such as perianal fistulas and complex perianal fistulas. The predictive purpose of this study is to develop a statistical predictive model with the information obtained from the descriptive purpose, in the hospitals of the healthcare network of the Autonomous Community of Madrid, capable of assigning any participant diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.

Detailed Description
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This is a retrospective and non-interventional study of participants with CD. The study will collect data from electronic medical records (EMRs) of the participants in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of EMRs and will describe the determining factors and develop a statistical model for predicting likely outcomes in participants with CD. This study will conduct an additional substudy to evaluate the performance of the system through a human assessment to be performed by the clinical experts at each participating site. The study will have a retrospective data collection from EMRs of the participants referring to last 5 years. The study will enroll approximately 3000 participants. All participants will be enrolled in one observational cohort. This multi-center trial will be conducted in Spain. The overall time for data collection in the study will be approximately 5 years.

Official Title
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Characterization of a Multidimensional Model to Predict the Course of Crohn's Disease: A Pilot Study

Conditions
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Inflammatory Bowel Diseases, Crohn Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Diagnosed with CD from the medical centers participating in the study.

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>Participants diagnosed with CD from approximately 12 to 15 investigational sites will be observed retrospectively for previous 5 years. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who had Relapses |  | Approximately 5 years | 
| Number of Participants who had Disease Related Complications |  | Approximately 5 years | 
| Number of day Hospital Visits |  | Approximately 5 years | 
| Number of Participants who had Surgeries |  | Approximately 5 years | 
| Number of Participants with Complications Such as Perianal Fistulas and Complex Perianal Fistulas |  | approximately 5 years | 
| Participant Flow |  | Approximately 5 years | 
| Number of Participants who Visit to Other Specialists |  | Approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of the Different Phenotypes | Development of a statistical predictive model capable of assigning any patient diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications. | Approximately 5 years | 
| Number of Participants who met the Eligibility Criteria to Receive Biological Treatment for CD |  | Approximately 5 years | 
| Number of Direct and Indirect Resources Used | Health care resources of participants with CD will be assessed in terms of direct and indirect resources. Direct resources will include number of hospital admissions, emergency and hospital visits, and tests performed, etc. Indirect resources related to decreased productivity of CD participants through a specific variable, the total number of work days lost due to CD during the study period. | Approximately 5 years | 
| Number of Essential Factors on Which Physician's Predictions of Participant Outcomes are Based |  | Approximately 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy