Clinical trial NCT04232228: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn Disease
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 6 months pre-index of C4T IBD application
measure: Crohn's Disease Related Secondary HRU in the 12 Months Post-Activation of C4T IBD Application (post-index)
timeFrame: Up to 12 months post index of C4T IBD application
Secondary outcomes:
measure: Crohn's Disease (CD)-Related Primary Healthcare Resource Utilization
timeFrame: 6 months pre- and 12-months post-index
measure: Number of Participants with Characteristics Including Duration of Disease, Current Treatments and Previous Treatments
timeFrame: At screening (during 6 months pre-index)
measure: Disease Activity of Participants Measured Using the Harvey-Bradshaw Index (HBI) or Modified HBI
timeFrame: 6 months pre- and 12 months post-index
measure: Disease Activity of Participants Measured Using Markers of Systemic Inflammation
timeFrame: 6 months pre- and 12 months post-index
measure: Disease Progression of Participants Measured Using the Fatigue Severity Scale (FSS)
timeFrame: Up to 12 months post-index
measure: Disease Progression of Participants Measured Using Number of Bowel Movements
timeFrame: Up to 12 months post-index
measure: Disease Progression of Participants Measured by Level of Abdominal Pain
timeFrame: Up to 12 months post-index
measure: Impact of C4T IBD on Health Related Quality of Life (HRQoL, General and Inflammatory Bowel Disease [IBD] Specific) and Productivity
timeFrame: Up to 12 months post-index
measure: Impact of C4T IBD on Participant's Level of Engagement with Their Disease Measured Using the Patient Activation Measure (PAM)
timeFrame: Up to 12 months post-index
measure: Patient- and HCP-Reported Satisfaction
timeFrame: Up to 12 months post-index
Other outcomes:
measure: Change in Number of Flares
timeFrame: 6 months pre-index to 12 months post index
measure: Change in Duration of Flares
timeFrame: 6 months pre-index to 12 months post index
measure: Change in Treatment Therapy
timeFrame: 6 months pre-index to 12 months post index
measure: Change in the Number of CD-Related Secondary HRU (Telephone calls, Outpatient Visits, Hospitalizations, Accident and Emergency Visits, Surgery)
timeFrame: 6 months pre- and 12-months post-index
measure: Change in the Number of CD-Related Primary HRU (Overall and by Type of HCP - General Practitioner [GP], Nurse)
timeFrame: 6 months pre- and 12-months post-index
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: