Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
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 |
|
Other |
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. |
6 months pre-index to 12 months post index |
|
Other |
Change in Treatment Therapy |
Change in CD treatment therapy including steroid use will be reported. |
6 months pre-index to 12 months post index |
|
Other |
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 |
|
Other |
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 |
|
Primary |
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 |
|
Primary |
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 |
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 |
|
Secondary |
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) |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|