Crohn DiseaseNCT04232228
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
An observational study of Crohn Disease, run by Janssen-Cilag Ltd. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Feb 2020to 4 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Crohn Disease
- Being tested
- No intervention
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention was used in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months pre-index of C4T IBD application
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.
Measured: Up to 12 months post index of C4T IBD application
Secondary outcomes (10)
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.
Measured: 6 months pre- and 12-months post-index
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.
Measured: At screening (during 6 months pre-index)
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.
Measured: 6 months pre- and 12 months post-index
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.
Measured: 6 months pre- and 12 months post-index
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.
Measured: Up to 12 months post-index
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.
Measured: Up to 12 months post-index
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.
Measured: Up to 12 months post-index
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.
Measured: Up to 12 months post-index
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.
Measured: Up to 12 months post-index
Patient- and HCP-Reported Satisfaction
Patient- and HCP-reported satisfaction of C4T IBD application will be reported based on bespoke online questionnaire.
Measured: Up to 12 months post-index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start7 Feb 2020
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Why it stopped: The Care4Today® IBD dashboard for HCPs and the patient app will be deactivated indefinitely and will no longer be available for use
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232228
- Sponsor's protocol ID
- CR108721
- Other IDs
- CNTO1275CRD4033
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04232228
- Acronym / sponsor ID
- CR108721
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Care4Today® IBD dashboard for HCPs and the patient app will be deactivated indefinitely and will no longer be available for use
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Crohn's Disease (CD) | – | Other: No interventionAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention was used in this study. | Other | Participants with Crohn's Disease (CD) |
Primary outcome
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
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)
Time frame: 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.
10 secondary outcomes
Crohn's Disease (CD)-Related Primary Healthcare Resource Utilization
Time frame: 6 months pre- and 12-months post-index
Number of Participants with Characteristics Including Duration of Disease, Current Treatments and Previous Treatments
Time frame: At screening (during 6 months pre-index)
Disease Activity of Participants Measured Using the Harvey-Bradshaw Index (HBI) or Modified HBI
Time frame: 6 months pre- and 12 months post-index
Disease Activity of Participants Measured Using Markers of Systemic Inflammation
Time frame: 6 months pre- and 12 months post-index
Disease Progression of Participants Measured Using the Fatigue Severity Scale (FSS)
Time frame: Up to 12 months post-index
Disease Progression of Participants Measured Using Number of Bowel Movements
Time frame: Up to 12 months post-index
Disease Progression of Participants Measured by Level of Abdominal Pain
Time frame: Up to 12 months post-index
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
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
Patient- and HCP-Reported Satisfaction
Time frame: Up to 12 months post-index
Results and safety
The study was stopped early (reason given: The Care4Today® IBD dashboard for HCPs and the patient app will be deactivated indefinitely and will no longer be available for use). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Janssen-Cilag Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Care4Today® IBD dashboard for HCPs and the patient app will be deactivated indefinitely and will no longer be available for use). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 6 months pre-index of C4T IBD application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.