Crohn Disease
Conditions
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.
Interventions
OTHERNo intervention
No intervention was used in this study.
Sponsors
Janssen-Cilag Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
| 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 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the Number of CD-Related Secondary HRU (Telephone calls, Outpatient Visits, Hospitalizations, Accident and Emergency Visits, Surgery) | 6 months pre- and 12-months post-index | 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. |
| Change in the Number of CD-Related Primary HRU (Overall and by Type of HCP - General Practitioner [GP], Nurse) | 6 months pre- and 12-months post-index | Change in the number of CD-related primary HRU (overall and by type of HCP - GP, nurse). |
| Change in Number of Flares | 6 months pre-index to 12 months post index | 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. |
| Change in Treatment Therapy | 6 months pre-index to 12 months post index | Change in CD treatment therapy including steroid use will be reported. |
| Change in Duration of Flares | 6 months pre-index 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. |
Countries
United Kingdom
Outcome results
None listed