Personalized Risk Estimation Tool for Crohn's Disease

Overseen By Emily W Lopes, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

80 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 5 6 7 8}

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

I have a close family member with inflammatory bowel disease.

Ability to understand and complete study questionnaires

I am older than 14 years.

Exclusion Criteria

Inability or unwillingness to comply with all patient visits and study-related procedures

I have been diagnosed with an inflammatory bowel disease.

Inability to understand or complete study questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the PRE-Crohn's tool or receive standard Crohn's disease education

8 weeks

Initial visit for tool introduction and education

Follow-up

Participants are monitored for changes in biomarkers and behaviors

6 months

Follow-up assessments at 8 weeks and 6 months

Study Completion

Final assessment of enrollment and retention rates

1.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool
• Standard Crohn's Disease Education

Trial Overview

The study tests a web-based tool called PRE-CD that estimates personal risk for Crohn's Disease against standard education on the condition. It aims to see if this tool can change behaviors and improve biomarkers related to Crohn's Disease risk in high-risk individuals.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool

Group II: Comparator arm Active Control 1 Intervention

Standard Crohn's Disease Education

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

American College of Gastroenterology

Collaborator

Trials

40

Recruited

6,900+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05332639

Personalized Risk Estimation for Crohn's Disease (PRE- ...

This tool will also display a participants' personalized summary of their risk factors for CD as well as educational tools for modifying these factors.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8040347/

Prognostic tools for identification of high risk in people with ...

... IBD tool. All identified studies were observational and were considered to provide weak evidence on the effectiveness of the tools. ... data on the two tools ...

3.

digital.ahrq.gov

digital.ahrq.gov/ahrq-funded-projects/evaluating-prediction-tool-and-decision-aid-patients-crohns-disease

Evaluating a Prediction Tool and Decision Aid for Patients with ...

Use of the Crohn's Disease Prediction Tool, a validated individualized risk prediction tool plus a web-based decision aid, resulted in improved shared ...

4.

academic.oup.com

academic.oup.com/crohnscolitis360/article/3/4/otab074/6414478

Performance Characteristics of a Clinical Decision Support ...

CDPATH risk assessment tool (formerly called the Personalized Risk and Outcome Prediction Tool [PROSPECT]) was developed to assess individual risk of Crohn's ...

5.

nature.com

nature.com/articles/s41746-025-01627-w

From trial data to personalized medicine: a validated ...

Lastly, we developed a prototype decision support tool to help improve treatment selection and patient outcomes for Crohn's disease. Overall ...

6.

trialx.com

trialx.com/clinical-trials/listings/307023/personalized-risk-estimation-for-crohns-disease-pre-crohns-implementation-and-feasibility/

Personalized Risk Estimation for Crohn's Disease (PRE ...

... personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated with risk for Crohn's disease in ...

7.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/340018

Personalized Risk Estimation for Crohn's Disease (PRE- ...

This tool will also display a participants' personalized summary of their risk factors for CD as well as educational tools for modifying these ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10726957/

Personalized Treatment for Crohn's Disease

Similarly, multiple tools are employed to monitor response to biologic therapies. Therapeutic drug monitoring (TDM) is a clinical tool that involves measurement ...