An observational study in Crohn Disease, sponsored by Janssen-Cilag Ltd.. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Janssen-Cilag Ltd. · Observational
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 32 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Janssen-Cilag Ltd. is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
No intervention was used in this study.
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
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.
Time frame: 6 months pre- and 12 months post-index
Disease Activity of Participants Measured Using Markers of Systemic Inflammation
Disease activity of participants using markers of systemic inflammation (Faecal calprotectin \[FCP\] and C reactive protein \[CRP\] levels) will be reported.
Time frame: 6 months pre- and 12 months post-index
Disease Progression of Participants Measured Using the Fatigue Severity Scale (FSS)
FSS is a short questionnaire implemented in the C4T IBD application that allows a person to measure their level of fatigue. It contains 9 items measuring the severity of fatigue symptoms in the last week.
Time frame: Up to 12 months post-index
Disease Progression of Participants Measured Using Number of Bowel Movements
Number of daily bowel movements will be measured using the bespoke patient-reported outcome (PRO) within the C4T IBD application. The questionnaire captures bowel movements recorded as day/night, according to the level of urgency, and presence of blood.
Time frame: Up to 12 months post-index
Disease Progression of Participants Measured by Level of Abdominal Pain
Abdominal pain will be measured using the bespoke PRO within the C4T IBD application. The questionnaire captures the level of abdominal pain on a scale from 0-10 (at 2 points intervals) where higher score indicates more severe pain.
Time frame: Up to 12 months post-index
Impact of C4T IBD on Health Related Quality of Life (HRQoL, General and Inflammatory Bowel Disease [IBD] Specific) and Productivity
Impact of C4T IBD on HRQoL (general and IBD specific) and productivity will be reported based on online questionnaires.
Time frame: Up to 12 months post-index
Impact of C4T IBD on Participant's Level of Engagement with Their Disease Measured Using the Patient Activation Measure (PAM)
Impact of C4T IBD on participant's level of engagement with their disease measured using the PAM will be reported based on online questionnaire.
Time frame: Up to 12 months post-index
Patient- and HCP-Reported Satisfaction
Patient- and HCP-reported satisfaction of C4T IBD application will be reported based on bespoke online questionnaire.
Time frame: Up to 12 months post-index
Change in Number of Flares
Change in number of flares will be reported from 6 months pre-index to 12 months post index. Flares will be identified as recorded in medical notes. A flare is defined as an exacerbation of Crohn's disease.
Time frame: 6 months pre-index to 12 months post index
Change in Duration of Flares
Change in duration of flares will be reported from 6 months pre-index to 12 months post index. Flares will be identified as recorded in medical notes. A flare is defined as an exacerbation of Crohn's disease.
Time frame: 6 months pre-index to 12 months post index
Change in Treatment Therapy
Change in CD treatment therapy including steroid use will be reported.
Time frame: 6 months pre-index to 12 months post index
Change in the Number of CD-Related Secondary HRU (Telephone calls, Outpatient Visits, Hospitalizations, Accident and Emergency Visits, Surgery)
Change in the number of CD-related secondary HRU (telephone calls, outpatient visits, hospitalizations, accident and emergency visits and surgery) between the 6 months pre- versus 12 months post-activation of C4T IBD will be reported.
Time frame: 6 months pre- and 12-months post-index
Change in the Number of CD-Related Primary HRU (Overall and by Type of HCP - General Practitioner [GP], Nurse)
Change in the number of CD-related primary HRU (overall and by type of HCP - GP, nurse).
Time frame: 6 months pre- and 12-months post-index
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Janssen-Cilag Ltd.