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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05332639

Collaborator

American College of Gastroenterology (Other)

162

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Crohn Disease Crohn Colitis Crohn's Ileocolitis Crohn's Gastritis Crohn's Jejunitis Crohn's Duodenitis Crohn's Esophagitis	Behavioral: Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool Behavioral: Standard Crohn's Disease Education	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool	Behavioral: Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool 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. Other Names: Intervention Arm
Active Comparator: Comparator arm Standard Crohn's Disease Education	Behavioral: Standard Crohn's Disease Education 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. Other Names: Comparator Arm

Arm

Intervention/Treatment

Experimental: Intervention Arm

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

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

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.

Other Names:

Intervention Arm

Active Comparator: Comparator arm

Standard Crohn's Disease Education

Behavioral: Standard Crohn's Disease Education

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.

Other Names:

Comparator Arm

Outcome Measures

Primary Outcome Measures

Change in composite Crohn's disease risk score (CD-RS) [6-weeks and 6-months post-intervention]
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.

Secondary Outcome Measures

Change in blood C reactive protein (CRP) level [6-weeks and 6-months post-intervention]
We will assess for a decreases in blood CRP level (mg/L) compared to baseline values.
Change in stool calprotectin level [6-weeks and 6-months post-intervention]
We will assess for a decreases in fecal/stool calprotectin level (mcg/g) compared to baseline values.
Change in blood biomarker positivity [6-weeks and 6-months post-intervention]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)
Adults greater than 18 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