Crohn DiseaseROADMAPNCT06338930
Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy
A study testing Remote monitoring in people with Crohn Disease and Colitis, Ulcerative, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
Routine follow-up of patients with inflammatory bowel disease (IBD) under stable doses of maintenance therapy or no IBD-related therapy at all, consists of intensive monitoring with prescheduled outpatient visits every six or twelve months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
- What is being tested?
- Remote monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants eligible for inclusion in this Trial must meet all of the following criteria:
- Patients with Crohn's disease, or ulcerative colitis, or IBD type unclassified
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Patients with access to Mynexuzhealth via smartphone or internet
- Patients must fluently speak, write, read Dutch.
Show all 12Show fewer
- Patients under stable treatment with oral mesalamine, thiopurines, methotrexate, subcutaneous biologicals and/or oral small molecules or under no such therapies at all for at least two years
- Patients having access to mynexuzhealth (plexus hospitals) or HiX (ZOL)
- Patients willing to perform a home-based fecal calprotectin measurement every three months through CalproSmart or a similar application, or to go to their general practitioner or a hospital close by to perform a classical ELISA to measure fecal calprotectin every three months*
- Patients willing to go to their general practitioner or a hospital close by to perform a blood test every year*
- Patients willing to go to their general practitioner or a hospital close by to perform the required three-monthly blood tests in case of treatment with thiopurines or methotrexate (evaluation of liver tests and complete blood count)*
- On the day of the classical outpatient clinic organized every two years, this can be performed at UZ Leuven All participants that are considered for Trial participation, per the above criteria will be documented via applicable log forms in Investigator Site File (including Screen Failures).
Who cannot join
- Participants eligible for this Trial must not meet any of the following criteria:
- Patients receiving an intravenous biological therapy or any form of corticosteroids (with the exception of inhaled or dermatological corticosteroids) in the last two years,
- Patients with a change in concomitant IBD therapies in the last two years (except for rectal therapies),
- Patients with IBD-related surgery in the past two years,
- Patients in whom the IBD team estimates that a more frequent follow-up is required (e.g., due to previous non-compliance, need for additional support, comorbidities such as primary sclerosing cholangitis, cancer, …)
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Pregnant patients at screening should be excluded. If the participant becomes pregnant during the study, case-by-case will be evaluated. Study participation or stop should be a mutual decision after clear discussion between physician and patient.
- Participants who meet one or more of the above exclusion criteria must not proceed to be enrolled/randomized in the Trial and will be identified via applicable log forms in Investigator Site File.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Routine follow-up of patients with inflammatory bowel disease (IBD) under stable doses of maintenance therapy or no IBD-related therapy at all, consists of intensive monitoring with prescheduled outpatient visits every six or twelve months. However, many of these patients do not require additional interventions from the IBD specialist during these visits. In addition, patients in long-term remission, often request a less frequent follow-up in the hospital and in consequence a less frequent absence from school or work. In conclusion, these routinely follow-up visits might put unnecessary burden on both healthcare providers and IBD patients, as well as on healthcare resources.
Until now, no clear standard was set for how to organize a remote monitoring programme that is feasible and safe in a large patient population. Despite the possible added value of remote monitoring for IBD patients on stable or no therapy and who are in remission, they are seldomly the targeted population in clinical trials analysing the effects of remote monitoring in IBD. Secondly, a significant reduction in outpatient clinic visits, is often not actively included in the programme, but more an outcome result. Finally, to compose a safe remote monitoring programme, subjective and objective parameters of disease activity should be collected.
With the ROADMAP study, the main objective is to evaluate the safety and feasibility of remote monitoring in IBD patients that are stable on their current therapy or receive no IBD-related therapy. Secondly, a health economic evaluation will be conducted. Patients will be randomised to either the remote monitoring group or control group. The remote monitoring group will visit the outpatient clinic after two years. During this two-year period, patients will be monitored remotely via three-monthly questionnaires (PRO-2, IBD disk, WPAI, EQ-5D-5L) and faecal calprotectin measures. An IBD nurse will evaluate all incoming data and act in case of red flags.
- Being tested
- Remote monitoring
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote monitoringOther
The intervention group will enroll in the remote monitoring programme. In the standard of care patients visit the outpatient clinic every six months. Patients in the control group will remain in the six-monthly follow-up programma, whereas patients in the intervention group will only visit the outpatient clinic two-yearly. The latter group will be monitored remotely via questionnaires, calprotectin analysis (using CalproSmart) and blood analyses. An IBD nurse will evaluate all incomming data and undertake action if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Remote monitoring group | Experimental | This group will follow the remote monitoring programme. Receives: Other: Remote monitoring |
| Control group | No intervention | This group will be monitored following the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient safety measured as the number of patients not requiring unplanned IBD related hospital visits (outpatient clinic, emergency department, hospitalization, or surgery) or rescue therapy with steroids within two years.
Non-inferiority trial: patient safety in the remote monitoring programme must be at least equal to patient safety in standard of care.
Measured: Two years
Secondary outcomes (11)
Costs and cost savings for hospital, RIZIV, employer, patient, … in the intervention group versus the control group.
costs and cost savings
Measured: Two years
Time saving for patients in the intervention group versus the control group will be measured using a "timing questionnaire".
Time savings
Measured: Two years
Number of telephone/email contacts with the IBD team within one year and within two years.
Contact moments with IBD team
Measured: Two years
Number of contacts with the general practitioner for IBD related reasons within one year and within two years.
Number of contacts with GP
Measured: Two years
Absence at work or school within one year and within two years in the intervention group versus the control group will be measured using the WPAI IBD questionnaire.
WPAI
Measured: Two years
Quality of life in the intervention group versus the control group will be measured using the European Quality of Live Five Dimension Five Level Scale.
European Quality of Live Five Dimension Five Level Scale: Aside from general questions regarding the patient's wellbeing, this questionnaire also contains a scale on which "current health" has to be scored with a score between 0 (verry sick) and 100 (perfect health).
Measured: Two years
Number of patients refusing to participate in this trial and the reason why.
Patients refusing to participate and reason
Measured: Two years
Reasons to stop remote monitoring.
The patient can always withdraw consent for participation in the ROADMAP study. In such a case, the investigator will try to collect information on the reason for withdrawing consent.
Another reason to stop remote monitoring might be that the treating physician decided that it was safer and in the best interest of the patient to stop the remote monitoring programme.
Measured: Two years
Patient's compliance, measured via missing data in the intervention versus the control group
- Number of patients filling out the PRO questionnaire every three months.
- Number of patients with a fecal calprotectin analysis every three months.
- Number of patients with a blood test performed every year / three months (in case of patients under thiopurines or methotrexate).
Measured: Two years
Satisfaction with the program in the intervention group.
Patient satisfaction questionnaire. We will ask patients about their satisfaction with the remote monitoring programme.
Measured: Two years
System usability in the intervention group.
System usability scale: is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. Each question has to be scored with a score of 1 (strongly disagree) to 5 (strongly agree). A high total score, means high system usability.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Feb 2025 (estimated)
- Primary completion2 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Ferrante, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338930
- Sponsor's protocol ID
- ROADMAP
- Acronym
- ROADMAP
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy
- ClinicalTrials.gov ID
- NCT06338930
- Acronym / sponsor ID
- ROADMAP / ROADMAP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 2 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 1 Apr 2024 (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.
Routine follow-up of patients with inflammatory bowel disease (IBD) under stable doses of maintenance therapy or no IBD-related therapy at all, consists of intensive monitoring with prescheduled outpatient visits every six or twelve months. However, many of these patients do not require additional interventions from the IBD specialist during these visits. In addition, patients in long-term remission, often request a less frequent follow-up in the hospital and in consequence a less frequent absence from school or work. In conclusion, these routinely follow-up visits might put unnecessary burden on both healthcare providers and IBD patients, as well as on healthcare resources.
Until now, no clear standard was set for how to organize a remote monitoring programme that is feasible and safe in a large patient population. Despite the possible added value of remote monitoring for IBD patients on stable or no therapy and who are in remission, they are seldomly the targeted population in clinical trials analysing the effects of remote monitoring in IBD. Secondly, a significant reduction in outpatient clinic visits, is often not actively included in the programme, but more an outcome result. Finally, to compose a safe remote monitoring programme, subjective and objective parameters of disease activity should be collected.
With the ROADMAP study, the main objective is to evaluate the safety and feasibility of remote monitoring in IBD patients that are stable on their current therapy or receive no IBD-related therapy. Secondly, a health economic evaluation will be conducted. Patients will be randomised to either the remote monitoring group or control group. The remote monitoring group will visit the outpatient clinic after two years. During this two-year period, patients will be monitored remotely via three-monthly questionnaires (PRO-2, IBD disk, WPAI, EQ-5D-5L) and faecal calprotectin measures. An IBD nurse will evaluate all incoming data and act in case of red flags.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote monitoring group | Experimental | Other: Remote monitoringThis group will follow the remote monitoring programme. |
| Control group | No intervention | –This group will be monitored following the standard of care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants eligible for inclusion in this Trial must meet all of the following criteria:
- Patients with Crohn's disease, or ulcerative colitis, or IBD type unclassified
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Patients with access to Mynexuzhealth via smartphone or internet
Key exclusion criteria (8 listed)
- Patients receiving an intravenous biological therapy or any form of corticosteroids (with the exception of inhaled or dermatological corticosteroids) in the last two years,
- Patients with a change in concomitant IBD therapies in the last two years (except for rectal therapies),
- Patients with IBD-related surgery in the past two years,
- Patients in whom the IBD team estimates that a more frequent follow-up is required (e.g., due to previous non-compliance, need for additional support, comorbidities such as primary sclerosing cholangitis, cancer, …)
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
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 |
|---|---|---|
| Remote monitoringThe intervention group will enroll in the remote monitoring programme. In the standard of care patients visit the outpatient clinic every six months. Patients in the control group will remain in the six-monthly follow-up programma, whereas patients in the intervention group will only visit the outpatient clinic two-yearly. The latter group will be monitored remotely via questionnaires, calprotectin analysis (using CalproSmart) and blood analyses. An IBD nurse will evaluate all incomming data and undertake action if necessary. | Other | Remote monitoring group |
Primary outcome
Patient safety measured as the number of patients not requiring unplanned IBD related hospital visits (outpatient clinic, emergency department, hospitalization, or surgery) or rescue therapy with steroids within two years.
Time frame: Two years
Non-inferiority trial: patient safety in the remote monitoring programme must be at least equal to patient safety in standard of care.
11 secondary outcomes
Costs and cost savings for hospital, RIZIV, employer, patient, … in the intervention group versus the control group.
Time frame: Two years
Time saving for patients in the intervention group versus the control group will be measured using a "timing questionnaire".
Time frame: Two years
Number of telephone/email contacts with the IBD team within one year and within two years.
Time frame: Two years
Number of contacts with the general practitioner for IBD related reasons within one year and within two years.
Time frame: Two years
Absence at work or school within one year and within two years in the intervention group versus the control group will be measured using the WPAI IBD questionnaire.
Time frame: Two years
Quality of life in the intervention group versus the control group will be measured using the European Quality of Live Five Dimension Five Level Scale.
Time frame: Two years
Number of patients refusing to participate in this trial and the reason why.
Time frame: Two years
Reasons to stop remote monitoring.
Time frame: Two years
Patient's compliance, measured via missing data in the intervention versus the control group
Time frame: Two years
Satisfaction with the program in the intervention group.
Time frame: Two years
System usability in the intervention group.
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Marc Ferrante principal investigator
UZ Leuven
Questions about this trial
What is this clinical trial studying?
A study testing Remote monitoring in people with Crohn Disease and Colitis, Ulcerative, run by Universitaire Ziekenhuizen KU Leuven.
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 12 inclusion and 8 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: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Ferrante (016 342845 ext. +32, marc.ferrante@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient safety measured as the number of patients not requiring unplanned IBD related hospital visits (outpatient clinic, emergency department, hospitalization, or surgery) or rescue therapy with steroids within two years. (time frame: Two years). 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 11 Dec 2024.