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

Study Overview
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Brief Summary
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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.

Official Title
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A UK Observational 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

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Crohn's Disease (CD)<br>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<br>* No intervention was used in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |