A Study to Evaluate the Impact of Care4Today® IBD, a Smart System to Facilitate the Management of Crohn's Disease by Patients and Health Care Providers

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Crohn Disease

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04232228

CR108721

CNTO1275CRD4033 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to describe the Crohn's Disease (CD)-related secondary healthcare resource utilisation of patients in the 6 months pre- and 12 months post-activation of Care4Today® inflammatory bowel disease (C4T IBD) alongside standard of care (SOC) in the management of CD.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with moderate to severe Crohn's disease (CD), diagnosed at least 6 months prior to index date, as documented by the treating healthcare professional (HCP)
• Participants with at least 6 months of continuous care in the study centre prior to index date
• Participants who have agreed to install Care4Today® inflammatory bowel disease (C4T IBD) on their iOS or android smartphone as part of their management of CD
• Participants providing informed written consent to participate in the study from the date of activation (including installation and linkage to HCP web interface) of the C4T IBD app on his/her smartphone

Exclusion criteria

• Participants with presence of ileorectal or ileal pouch-anal anastomosis documented in their medical records
• Participants in remission for over 2 years as documented in their medical records
• Participants participating in an interventional clinical trial
• Participants participating in an observational study where the protocol interferes with the C4T study in the opinion of the principal investigator at each site
• Participants with insufficient command of English to interact effectively with C4T IBD and complete the study questionnaires in the opinion of the principal investigator at each site
• Participants unable or unwilling to provide their informed written consent to participate in the study

Trial design

32 participants in 1 patient group

Participants with Crohn's Disease (CD)

Description:

Adult participants with moderate to severe CD who agree to be part of the study and who fit the inclusion/exclusion criteria and use Care4Today inflammatory bowel disease (C4T IBD) alongside standard of care (SOC) at participating centers will be observed. Data available per clinical practice and via the C4T IBD application will be collected within this study. Participants will also be asked to complete questionnaires that are sent directly to the patients, which are not completed as part of clinical practice or via the application. Relevant data will be collected by prospectively following participants from the index date for 12 months, and also by retrospectively collecting data for the 6-month period prior to the index date from participant's medical records. Index is the activation date of C4T IBD application in participant's smartphone.

Treatment:

Other: No intervention