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

Mass General Brigham

Status: Enrolling

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

Treatments: Behavioral: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool; Behavioral: Standard Crohn's Disease Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05332639

2022p000905

1K23DK136977-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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-Crohn's) 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-Crohn's 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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/IBD unclassified)
• Individuals greater than 14 years of age

Exclusion criteria

• Inability to provide informed consent
• Inability 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/IBD unclassified)
• Evidence of clinical signs or symptoms of inflammatory bowel disease, identified by a modified version of the Harvey-Bradshaw Index for CD activity

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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

Treatment:

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

Comparator arm

Active Comparator group

Description:

Standard Crohn's Disease Education

Treatment:

Behavioral: Standard Crohn's Disease Education