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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04232228
• Other study ID #: CR108721
• Secondary ID: CNTO1275CRD4033
• Status: Terminated
• Start date: February 7, 2020
• Est. completion date: April 4, 2022

Study information

• Verified date: June 2023
• Source: Janssen-Cilag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• No intervention
No intervention was used in this study.

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Country where clinical trial is conducted

United Kingdom, 

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