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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275CRD4033 | Other Identifier | Janssen-Cilag Ltd. |
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The Care4Today® IBD dashboard for HCPs and the patient app will be deactivated indefinitely and will no longer be available for use
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention was used in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months pre- and 12-months post-index |
| Number of Participants with Characteristics Including Duration of Disease, Current Treatments and Previous Treatments |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months pre-index to 12 months post index |
| Change in Duration of Flares |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd. Clinical Trial | Janssen-Cilag Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
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
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 12 months post-index |
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. |
| 6 months pre-index to 12 months post index |
| Change in Treatment Therapy | Change in CD treatment therapy including steroid use will be reported. | 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. | 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). | 6 months pre- and 12-months post-index |
| D007410 | Intestinal Diseases |