Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool, Standard Crohn's Disease Education.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases, Crohn Disease, Crohn Colitis, Crohn's Ileocolitis. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Behavioral Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
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 displa - 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-Crohn's tool as well.
Primary outcome measures
- Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion [Time frame: 1.5 years and time of study completion]
Secondary outcome measures (12)
- Motivation to change smoking behavior [Time frame: 8 weeks and 6 months]
- Motivation to change diet [Time frame: 8 weeks and 6 months]
- Motivation to change physical activity [Time frame: 8 weeks and 6 months]
- Change in physical activity [Time frame: 8 weeks and 6 months]
- Change in fruit intake [Time frame: 8 weeks and 6 months]
- Change in vegetable intake [Time frame: 8 weeks and 6 months]
- Change in processed meat intake [Time frame: 8 weeks and 6 months]
- Change in fiber intake [Time frame: 8 weeks and 6 months]
- Change in added sugar intake [Time frame: 8 weeks and 6 months]
- Change in smoking behaviors [Time frame: 8 weeks and 6 months]
- Change in C-reactive protein (CRP; mg/L) [Time frame: 8 weeks and 6 months]
- Change in fecal calprotectin (mcg/g) [Time frame: 8 weeks and 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Publications
- Colditz GA, Dart H. Commentary: 20 years online with "Your Disease Risk". Cancer Causes Control. 2021 Jan;32(1):5-11. doi: 10.1007/s10552-020-01356-3. Epub 2020 Oct 17. PMID 33068181
Identifiers
NCT: NCT05332639 · 2022p000905 · 1K23DK136977-01