About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
- Standard Crohn's Disease Education
Treatment groups
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
American College of Gastroenterology
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator