Personalized Risk Estimation for Crohn's Disease (PRE-CD): Implementation and Feasibility

Study Overview
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Brief Summary
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The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-CD) tool on behaviors and biomarkers associated with risk for Crohn's disease in unaffected first-degree relatives of patients with inflammatory bowel disease. We hypothesize that personalized risk disclosure via the PRE-CD educational tool is both feasible and successful in modifying behaviors associated with Crohn's disease risk and normalizing pre-clinical disease biomarkers when compared to standard Crohn's disease education. Broadly, completion of this project will also help elucidate the role of lifestyle and dietary factors in pre-clinical Crohn's disease development in high-risk individuals, and provide novel insight into potential strategies for disease prevention in this population.

Official Title
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Personalized Risk Estimation for Crohn's Disease (PRE-CD): Implementation and Feasibility

Conditions
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Inflammatory Bowel Diseases, Crohn Disease, Crohn Colitis, Crohn's Ileocolitis, Crohn's Gastritis, Crohn's Jejunitis, Crohn's Duodenitis, Crohn's Esophagitis

Intervention / Treatment
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* Behavioral: Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool
* Behavioral: Standard Crohn's Disease Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to give informed consent Ability and willingness to comply with all patient visits and study-related procedures Ability to understand and complete study questionnaires Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis) Individuals greater than 14 years of age Exclusion Criteria: Inability to provide informed consent Inability or unwillingness to comply with all patient visits and study-related procedures Inability to understand or complete study questionnaires Patients with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or indeterminate colitis) Evidence of clinical signs or symptoms of inflammatory bowel disease, identified by a modified version of the Harvey-Bradshaw Index for CD activity

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool | Behavioral: Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool<br>* We will develop a web-based, personalized risk estimation for CD (PRE-CD) tool to quantitate participants' relative risk (RR) and lifetime risk of CD based on known risk factors for disease. We will consider the following risk factors for Crohn's disease: body mass index (BMI), smoking history, NSAID use, intake of fruit, vegetables, and fiber, oral contraceptive use (females), and anti-microbial biomarker positivity. This tool will also display a participants' personalized summary of their risk factors for CD as well as educational tools for modifying these factors. Construction of this tool is based on the Your Disease Risk tool developed by the Siteman Cancer Center at Washington University in St. Louis School of Medicine. The interventional group will also receive standard education about Crohn's disease (comparison group intervention) via the web-based tool.<br>* Other names: Intervention Arm;|
| Active Comparator: Comparator arm<br>Standard Crohn's Disease Education | Behavioral: Standard Crohn's Disease Education<br>* The comparison group will receive standard education about Crohn's disease, which will include information regarding the prevalence of disease, clinical presentation including signs and symptoms of disease, and treatment options including available medications. Upon completion of the study, the comparator arm will be given the option of receiving their personalized risk of Crohn's disease with the PRE-CD tool as well.<br>* Other names: Comparator Arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in composite Crohn's disease risk score (CD-RS) | A composite Crohn's disease risk score (CD-RS) will be constructed that summarizes participants' behavioral and dietary patterns associated with risk for Crohn's disease. Higher CD-RS scores will reflect increased exposure to CD risk factors. Our primary outcome will be a binary outcome (yes/no) for achieving a one-point decrease in CD-RS. | 6-weeks and 6-months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood C reactive protein (CRP) level | We will assess for a decreases in blood CRP level (mg/L) compared to baseline values. | 6-weeks and 6-months post-intervention | 
| Change in stool calprotectin level | We will assess for a decreases in fecal/stool calprotectin level (mcg/g) compared to baseline values. | 6-weeks and 6-months post-intervention | 
| Change in blood biomarker positivity | We will assess for a reduction in seropositivity for one of several Crohn's disease biomarkers (p-antineutrophil cytoplasmic antibody, anti-saccharomyces cerevisiae antibody immunoglobulin A (IgA) and immunoglobulin G (IgG), anti-outer membrane protein C IgA, and anti-flagellins anti-CBir1 IgG, anti-A4-Fla2 IgG and anti-FlaX IgG). Each biomarker will be assessed as positive or negative if a biomarker is present or absent, respectfully. The outcome will be a binary outcome (yes/no) for achieving a change from a positive to negative biomarker for disease. | 6-weeks and 6-months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease