Personalized Risk Estimation Tool for Crohn's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new online tool called the Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool, which estimates personal risk for Crohn's disease. It aims to help individuals change habits and improve health markers before any disease signs appear. The trial compares the new tool to standard education about Crohn's disease to determine which is more effective. It targets individuals with close family members who have inflammatory bowel disease but do not have the disease themselves. The study seeks to find ways to prevent Crohn's by focusing on lifestyle and diet. As an unphased trial, it offers a unique opportunity to contribute to preventive health strategies for Crohn's disease.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the PRE-Crohn's tool is safe?
Research has shown that the Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool helps individuals understand their risk factors for Crohn's disease. It provides educational resources to guide lifestyle changes that may reduce these risks. This tool does not require medication or medical procedures, which generally results in fewer side effects. As a non-invasive, informational tool, it presents no direct evidence of safety concerns. Instead, it focuses on teaching individuals how to change their habits to manage disease risk.12345
Why are researchers excited about this trial?
Researchers are excited about the Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool because it offers a customized approach that could transform how patients manage their condition. Unlike standard treatment options that primarily focus on medication and broad strategies to control inflammation, the PRE-CD tool aims to provide tailored insights into a patient's unique risk factors. This personalized method has the potential to optimize treatment plans, helping patients avoid unnecessary treatments and focus on interventions that are most likely to be effective for them. By focusing on individualized risk, the PRE-CD tool could lead to more precise and effective management of Crohn's disease, which is a significant step forward from the one-size-fits-all approach currently in use.
What evidence suggests that the PRE-Crohn's tool is effective for Crohn's disease risk management?
Research has shown that tools designed to estimate personal risk can help people understand their chances of developing Crohn's disease. In this trial, participants in the intervention arm will use the PRE-Crohn's tool, which provides a personalized summary of risk factors and offers educational resources to help change behaviors linked to the disease. Meanwhile, the comparator arm will receive standard Crohn's Disease education. Studies have found that similar tools can improve decision-making and encourage healthier lifestyle changes in people at high risk. Although the evidence is still developing, these tools show promise in potentially lowering the risk of developing Crohn's disease by guiding users toward healthier habits.25678
Who Is on the Research Team?
Emily W. Lopes, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for individuals over 14 years old who have a first-degree relative with inflammatory bowel disease but do not show signs of the disease themselves. They must be able to understand and fill out questionnaires, give informed consent, and follow all study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants use the PRE-Crohn's tool or receive standard Crohn's disease education
Follow-up
Participants are monitored for changes in biomarkers and behaviors
Study Completion
Final assessment of enrollment and retention rates
What Are the Treatments Tested in This Trial?
Interventions
- Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool
- Standard Crohn's Disease Education
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
American College of Gastroenterology
Collaborator