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Completed

NCT Number: NCT03668249

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HM Hospitales, Boadilla, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of Participants who had Relapses

    Time frame: Approximately 5 years

  2. Number of Participants who had Disease Related Complications

    Time frame: Approximately 5 years

  3. Number of day Hospital Visits

    Time frame: Approximately 5 years

  4. Number of Participants who had Surgeries

    Time frame: Approximately 5 years

  5. Number of Participants with Complications Such as Perianal Fistulas and Complex Perianal Fistulas

    Time frame: approximately 5 years

  6. Participant Flow

    Time frame: Approximately 5 years

  7. Number of Participants who Visit to Other Specialists

    Time frame: Approximately 5 years

Secondary outcomes

  1. Prevalence of the Different Phenotypes

    Time frame: 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.

  2. Number of Participants who met the Eligibility Criteria to Receive Biological Treatment for CD

    Time frame: Approximately 5 years

  3. Number of Direct and Indirect Resources Used

    Time frame: 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.

  4. Number of Essential Factors on Which Physician's Predictions of Participant Outcomes are Based

    Time frame: Approximately 5 years

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Acronym: PREMONITION-CD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2018
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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