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

Massachusetts General Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Inflammatory Bowel Diseases Crohn Disease Crohn Colitis Crohn's Ileocolitis

Interventions

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

We will develop a web-based, personalized risk estimation for CD (PRE-Crohn's) 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, fiber, and added sugar; oral contraceptive use (females); antibiotic use; breast-feeding; pets in home; 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.

Standard Crohn's Disease EducationBEHAVIORAL

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-Crohn's tool as well.

Eligibility

Sex: ALLMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion

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.

Time frame: 1.5 years and time of study completion

Secondary Outcomes

Motivation to change smoking behavior

We will measure change in contemplation ladder scores for motivation to change smoking behavior (yes/no for achieving a 1-point increase)