An observational study to assess the relationship between disease flare states and patient-reported health data, health data from a wearable activity tracker, and biomarker data obtained through a decentralized process in patients with inflammatory bowel disease

F. Hoffmann-La Roche Ltd0 sites350 target enrollmentMarch 11, 2022

Overview

No summary available.

Registry

who.int

Start Date

March 11, 2022

End Date

January 31, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

•Current inclusion criteria as of 01/08/2022:
•1\. Age of more than 18 years
•2\. Diagnosis of moderate\-severe CD or UC by a healthcare provider via colonoscopy
•3\. One or more IBD flares in the previous 12 months, with a flare defined as an occurrence in an unplanned visit to a primary gastroenterologist or IBD specialist or the initiation of treatment to manage IBD or due to change in the medical management of IBD by a healthcare provider
•4\. The participant is a resident of the United States and can speak, read, and understand English
•5\. Agree to wear an activity tracker on the same wrist 24 hours a day (except when charging the tracker) for the duration of the study
•6\. Agreement to self\-collect saliva and stool samples and store one stool sample in the freezer until pick\-up at least every 4 weeks
•7\. Must have a smartphone that is compatible with the IBDoc CalApp (list of compatible devices is available at: https://www.ibdoc.net/support/?lang\=en) and must be able to take an at\-home stool test and upload results using a smartphone app every 2 weeks
•8\. Agreement and ability to store up to four sample kits in the refrigerator during the study
•9\. Agreement and ability to receive shipments at a mailing address that is not a post office box

•Current exclusion criteria as of 01/08/2022:
•1\.Has a diagnosis of ischemic/radiation colitis
•2\. Has a diagnosis of primary sclerosing cholangitis
•3\. Has a diagnosis of an abdominal abscess or perianal abscess requiring surgical intervention or antibiotic treatment within the past 3 months
•4\. Has a history of cancer, excluding non\-melanoma skin cancer that was completely removed
•5\. Has a history of organ transplant
•6\. Diagnosis of, or treatment for, infectious colitis, such as CMV colitis or Clostridium difficile colitis, within the past 60 days
•7\. Hospitalization within the past 8 weeks
•8\. Participation in a treatment program for drug, alcohol, or chemical abuse in the past 6 months
•9\. Use of biologics for non\-IBD conditions