Personalized Risk Estimation for Crohn’s Disease (PRE-Crohn’s): An Implementation and Feasibility Study
General Information:
Massachusetts General Hospital is conducting a research study to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for CD (PRE-Crohn’s) tool on behaviors and biomarkers associated with CD in unaffected first-degree relatives (FDRs) of patients with inflammatory bowel disease.
Eligibility:
Inclusion Criteria:
• Age 14 or older (those 14-17 must have a parent or guardian to consent)
• Ability to give informed consent
• Ability and willingness to comply with all study visits and study-related procedures (which will include participation in at least 3 in-person visits conducted at Massachusetts General Hospital in Boston, MA)
• Ability to understand and complete study questionnaires
• Must have at least one first-degree relative (parent, sibling or child) with any type of inflammatory bowel disease (IBD) and be able to provide proof of their diagnosis.
Exclusion Criteria:
• Inability to provide informed consent
• Unable to comply with all study visits and study-related procedures
• Inability to understand or complete study questionnaires
• Individuals with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn’s disease, or inflammatory bowel disease-unclassified)
• Evidence of clinical signs or symptoms of IBD, identified by a modified version of the Harvey-Bradshaw Index for CD activity.
Study Details:
Study description/explanation of participation:
This research study uses a web-based module called the PRE-Crohn’s (Personalized Risk Estimation for Crohn’s Disease) tool as well as markers of Crohn’s disease in the blood and stool to (1) estimate a person’s risk for developing Crohn’s disease and (2) counsel them on how to modify their risk factors for disease. One group will receive the PRE-Crohn’s tool as the intervention, and the other will receive standard (non-personalized) education about Crohn’s disease. We want to see if the PRE-Crohn’s tool can help change a person’s behaviors when compared to the standard education group. The study will last approximately 6-7 months with study visits at baseline, 8-weeks post-intervention, and 6-months post-intervention. Each visit will require questionnaire completion, height and weight measurements, stool collection, and a blood draw. Parts of this study, such as the questionnaires and stool collection, may be done from home, while other parts, such as the blood collection, will need to be done at Massachusetts General Hospital. Participants will be compensated $75 for each completed visit for a total of $225.
Description of treatment or intervention (mechanism of action):
Upon study entry, all participants will complete a lifestyle and dietary questionnaire assessing their smoking history, medication usage, physical activity, as well as daily consumption of foods like fruit, vegetables, whole grains, processed meat, fish, and sugary beverages. We will also measure height and weight to calculate body mass index (BMI), and collect stool and blood to test for biomarkers for Crohn’s disease. Participants will then be assigned to one of two groups: the intervention group, or the control group.
The intervention group will receive a web-based, Personalized Risk Estimation for Crohn’s disease (PRE-Crohn’s) tool, that will calculate a person’s risk for developing Crohn’s disease based on their questionnaire responses and stool and blood results. The PRE-Crohn’s module will explain to the user their risk for Crohn’s disease both in plain language and visually using helpful images and diagrams. The module will also provide education and counseling on how to modify behaviors associated with Crohn’s disease development. The 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 Medicine1. Finally, the intervention group will also receive standard education about Crohn's disease via the PRE-Crohn’s tool.
The control 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, participants assigned to the control group will also be given the opportunity to receive their personalized risk of Crohn's disease with the PRE-Crohn’s tool.
Patient Participation Requirements:
Participants will be asked to complete a detailed questionnaire related to their lifestyle and dietary habits along with height and weight measurements, blood draws, and stool collections at baseline, 8-weeks and 6-months post-intervention.
Possible risks and side effects:
Psychological
In this study, you may receive information on your risk of developing Crohn’s. Receiving information on your risk for developing Crohn’s disease may be associated with anxiety or stress due to uncertainty of whether one will develop the disease or not. If you enroll and subsequently decide you no longer want to receive this information after enrollment, you may choose to leave the study at any time.
Stool Collection
Accidental exposure to preservatives in the stool collection materials may cause skin irritation. These preservatives can be washed off with soap and water.
Blood Sampling
Blood sampling carries minor risks including brief pain, bruising, feeling faint when blood is drawn, or rarely infections, which can be treated. Research staff performing blood draws will use MGH standard sanitization procedures to minimize these risks.
Confidentiality
There is a risk of breach of confidentiality involving your protected health information. To minimize this risk, study codes will be used instead of our name on all samples and health information. Study staff with do everything in their power to prevent breaches in confidentiality.