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Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
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.
Details
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 80 |
| Start date | 2025-10-03 |
| Completion | 2027-11 |
Conditions
- Inflammatory Bowel Diseases
- Crohn Disease
- Crohn Colitis
- Crohn's Ileocolitis
- Crohn's Gastritis
- Crohn's Jejunitis
- Crohn's Duodenitis
- Crohn's Esophagitis
Interventions
- Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
- Standard Crohn's Disease Education
Primary outcomes
- Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion — 1.5 years and time of study completion
The total enrollment at 1.5 years and the retention rate recorded at the conclusion of the study will be measured based on completion of the 6-month survey.
Countries
United States