Personalized Risk Estimation Tool for Crohn's Disease

Recruiting in Palo Alto (17 mi)

Overseen by Emily W. Lopes, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of 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.

Research Team

Emily W. Lopes, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals over 14 years old who have a first-degree relative with inflammatory bowel disease but do not show signs of the disease themselves. They must be able to understand and fill out questionnaires, give informed consent, and follow all study procedures.

Inclusion Criteria

I have a close family member with inflammatory bowel disease.

Ability to understand and complete study questionnaires

I am older than 14 years.

Exclusion Criteria

Inability or unwillingness to comply with all patient visits and study-related procedures

I have been diagnosed with an inflammatory bowel disease.

Inability to understand or complete study questionnaires

Treatment Details

Interventions

• Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool (Behavioural Intervention)
• Standard Crohn's Disease Education (Behavioural Intervention)

Trial Overview The study tests a web-based tool called PRE-CD that estimates personal risk for Crohn's Disease against standard education on the condition. It aims to see if this tool can change behaviors and improve biomarkers related to Crohn's Disease risk in high-risk individuals.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

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

Group II: Comparator arm Active Control 1 Intervention

Standard Crohn's Disease Education

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

American College of Gastroenterology

Collaborator

Trials

40

Recruited

6,900+