- ICH GCP
- US Clinical Trials Registry
- 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
June 30, 2023 updated by: Janssen-Cilag Ltd.
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
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leeds, United Kingdom, LS9 7TF
- Leeds Teaching Hospitals NHS Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Participants with Crohn's Disease (CD)
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.
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No intervention was used in this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: 6 months pre-index of C4T IBD application
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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.
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6 months pre-index of C4T IBD application
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Crohn's Disease Related Secondary HRU in the 12 Months Post-Activation of C4T IBD Application (post-index)
Time Frame: Up to 12 months post index of C4T IBD application
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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.
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Up to 12 months post index of C4T IBD application
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Crohn's Disease (CD)-Related Primary Healthcare Resource Utilization
Time Frame: 6 months pre- and 12-months post-index
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CD-related primary healthcare resource utilization of participants in the 6 months pre- and 12-months post-index of C4T IBD will be reported.
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6 months pre- and 12-months post-index
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Number of Participants with Characteristics Including Duration of Disease, Current Treatments and Previous Treatments
Time Frame: At screening (during 6 months pre-index)
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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.
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At screening (during 6 months pre-index)
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Disease Activity of Participants Measured Using the Harvey-Bradshaw Index (HBI) or Modified HBI
Time Frame: 6 months pre- and 12 months post-index
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Disease activity of participants using HBI or modified HBI will be reported.
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6 months pre- and 12 months post-index
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Disease Activity of Participants Measured Using Markers of Systemic Inflammation
Time Frame: 6 months pre- and 12 months post-index
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Disease activity of participants using markers of systemic inflammation (Faecal calprotectin [FCP] and C reactive protein [CRP] levels) will be reported.
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6 months pre- and 12 months post-index
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Disease Progression of Participants Measured Using the Fatigue Severity Scale (FSS)
Time Frame: Up to 12 months post-index
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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.
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Up to 12 months post-index
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Disease Progression of Participants Measured Using Number of Bowel Movements
Time Frame: Up to 12 months post-index
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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.
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Up to 12 months post-index
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Disease Progression of Participants Measured by Level of Abdominal Pain
Time Frame: Up to 12 months post-index
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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.
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Up to 12 months post-index
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Impact of C4T IBD on Health Related Quality of Life (HRQoL, General and Inflammatory Bowel Disease [IBD] Specific) and Productivity
Time Frame: Up to 12 months post-index
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Impact of C4T IBD on HRQoL (general and IBD specific) and productivity will be reported based on online questionnaires.
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Up to 12 months post-index
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Impact of C4T IBD on Participant's Level of Engagement with Their Disease Measured Using the Patient Activation Measure (PAM)
Time Frame: Up to 12 months post-index
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Impact of C4T IBD on participant's level of engagement with their disease measured using the PAM will be reported based on online questionnaire.
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Up to 12 months post-index
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Patient- and HCP-Reported Satisfaction
Time Frame: Up to 12 months post-index
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Patient- and HCP-reported satisfaction of C4T IBD application will be reported based on bespoke online questionnaire.
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Up to 12 months post-index
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Number of Flares
Time Frame: 6 months pre-index to 12 months post index
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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.
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6 months pre-index to 12 months post index
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Change in Duration of Flares
Time Frame: 6 months pre-index to 12 months post index
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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.
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6 months pre-index to 12 months post index
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Change in Treatment Therapy
Time Frame: 6 months pre-index to 12 months post index
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Change in CD treatment therapy including steroid use will be reported.
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6 months pre-index to 12 months post index
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Change in the Number of CD-Related Secondary HRU (Telephone calls, Outpatient Visits, Hospitalizations, Accident and Emergency Visits, Surgery)
Time Frame: 6 months pre- and 12-months post-index
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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.
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6 months pre- and 12-months post-index
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Change in the Number of CD-Related Primary HRU (Overall and by Type of HCP - General Practitioner [GP], Nurse)
Time Frame: 6 months pre- and 12-months post-index
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Change in the number of CD-related primary HRU (overall and by type of HCP - GP, nurse).
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6 months pre- and 12-months post-index
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2020
Primary Completion (Actual)
April 4, 2022
Study Completion (Actual)
April 4, 2022
Study Registration Dates
First Submitted
January 15, 2020
First Submitted That Met QC Criteria
January 15, 2020
First Posted (Actual)
January 18, 2020
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 30, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108721
- CNTO1275CRD4033 (Other Identifier: Janssen-Cilag Ltd.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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