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
- Conditions
- Crohn Disease
- Interventions
- Other: No intervention
- Registration Number
- NCT04232228
- Lead Sponsor
- Janssen-Cilag Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Crohn's Disease (CD) No intervention 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.
- Primary Outcome Measures
Name Time Method 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) 6 months pre-index of C4T IBD application 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.
Crohn's Disease Related Secondary HRU in the 12 Months Post-Activation of C4T IBD Application (post-index) Up to 12 months post index of C4T IBD application 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.
- Secondary Outcome Measures
Name Time Method 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 using HBI or modified HBI will be reported.
Crohn's Disease (CD)-Related Primary Healthcare Resource Utilization 6 months pre- and 12-months post-index CD-related primary healthcare resource utilization of participants in the 6 months pre- and 12-months post-index of C4T IBD will be reported.
Number of Participants with Characteristics Including Duration of Disease, Current Treatments and Previous Treatments At screening (during 6 months pre-index) 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.
Disease Activity of Participants Measured Using Markers of Systemic Inflammation 6 months pre- and 12 months post-index Disease activity of participants using markers of systemic inflammation (Faecal calprotectin \[FCP\] and C reactive protein \[CRP\] levels) will be reported.
Disease Progression of Participants Measured Using the Fatigue Severity Scale (FSS) Up to 12 months post-index 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.
Impact of C4T IBD on Participant's Level of Engagement with Their Disease Measured Using the Patient Activation Measure (PAM) Up to 12 months post-index Impact of C4T IBD on participant's level of engagement with their disease measured using the PAM will be reported based on online questionnaire.
Disease Progression of Participants Measured Using Number of Bowel Movements Up to 12 months post-index 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.
Disease Progression of Participants Measured by Level of Abdominal Pain Up to 12 months post-index 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.
Impact of C4T IBD on Health Related Quality of Life (HRQoL, General and Inflammatory Bowel Disease [IBD] Specific) and Productivity Up to 12 months post-index Impact of C4T IBD on HRQoL (general and IBD specific) and productivity will be reported based on online questionnaires.
Patient- and HCP-Reported Satisfaction Up to 12 months post-index Patient- and HCP-reported satisfaction of C4T IBD application will be reported based on bespoke online questionnaire.
Trial Locations
- Locations (1)
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom