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

Completed

• Conditions: Inflammatory Bowel Diseases; Crohn Disease

• Registration Number: NCT03668249
• Lead Sponsor: Takeda

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Study Start: 2018-09-26
• Primary Completion: 2019-09-16
• Study Completion: 2019-09-16
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5938

Inclusion Criteria

1. Diagnosed with CD from the medical centers participating in the study.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Prevalence of the Different Phenotypes	Approximately 5 years	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.
Number of Participants who met the Eligibility Criteria to Receive Biological Treatment for CD	Approximately 5 years
Number of Direct and Indirect Resources Used	Approximately 5 years	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.
Number of Essential Factors on Which Physician's Predictions of Participant Outcomes are Based	Approximately 5 years

Trial Locations

Locations (8)

H. U. de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain

H.U. Puerta de Hierro - Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

H.U. Rey Juan Carlos; 🇪🇸 Mostoles, Madrid, Spain

H.U. Infanta Sofia; 🇪🇸 San Sebastian de Los Reyes, Madrid, Spain

H. U. Infanta Elena; 🇪🇸 Valdemoro, Madrid, Spain

H Infanta Leonor y Virgen de la Torre; 🇪🇸 Vallecas, Madrid, Spain

H La Princesa; 🇪🇸 Madrid, Spain

HM Hospitales; 🇪🇸 Boadilla, Madrid, Spain