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-Cilag Ltd.32 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Crohn Disease

Interventions

No interventionOTHER

No intervention was used in this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Outcomes

Primary Outcomes

Crohn's Disease Related Secondary Health Related Utilization (HRU) in the 6 Months Pre-Activation of Care4Today® Inflammatory Bowel Disease (C4T IBD) Application (Pre-Index)

The number of gastroenterology health care provider (HCP) contacts per participant in the 6 months pre-index will be reported. Index is the activation date of C4T IBD application in participant's smartphone.

Time frame: 6 months pre-index of C4T IBD application

Crohn's Disease Related Secondary HRU in the 12 Months Post-Activation of C4T IBD Application (post-index)

The number of gastroenterology HCP contacts per participant in the 12 months post-index will be reported. The 12 months post-index period will be split into two time periods: 0-6 months post-index and 6-12 months post-index. The 0-6 and 6-12 month post-index periods will be described separately.

Time frame: Up to 12 months post index of C4T IBD application

Secondary Outcomes

Crohn's Disease (CD)-Related Primary Healthcare Resource Utilization

CD-related primary healthcare resource utilization of participants in the 6 months pre- and 12-months post-index of C4T IBD will be reported.

Time frame: 6 months pre- and 12-months post-index

Number of Participants with Characteristics Including Duration of Disease, Current Treatments and Previous Treatments

Characteristics of participants enrolled into the study including, but not limited to, duration of disease, current treatments (ongoing at the time of C4T IBD activation) and previous treatments (including reasons for treatment changes where available) will be reported. Data will be collected from participant's medical records.

Time frame: At screening (during 6 months pre-index)

Disease Activity of Participants Measured Using the Harvey-Bradshaw Index (HBI) or Modified HBI

Disease activity of participants using HBI or modified HBI will be reported.

Data from ClinicalTrials.gov

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