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

NCT04232228 | Terminated

• 2 other identifiers: CR108721CNTO1275CRD4033
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 12 months post index of C4T IBD application

Secondary Outcomes (10)

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

  6 months pre- and 12-months post-index

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

  At screening (during 6 months pre-index)

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

  6 months pre- and 12 months post-index

• Disease Activity of Participants Measured Using Markers of Systemic Inflammation

  6 months pre- and 12 months post-index

• Disease Progression of Participants Measured Using the Fatigue Severity Scale (FSS)

  Up to 12 months post-index

Other Outcomes (5)

• Change in Number of Flares

  6 months pre-index to 12 months post index

• Change in Duration of Flares

  6 months pre-index to 12 months post index

• Change in Treatment Therapy

  6 months pre-index to 12 months post index

Study Arms (1)

Participants with Crohn's Disease (CD)

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention was used in this study.

Participants with Crohn's Disease (CD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with moderate to severe CD for at least 6 months and with at least 6 months of continuous care, which may include conventional and/or biological therapies.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Janssen-Cilag Ltd. Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: February 7, 2020
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)