Clinical trial NCT06338930: Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy
Official title: Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

Participants eligible for inclusion in this Trial must meet all of the following criteria:

1. Patients with Crohn's disease, or ulcerative colitis, or IBD type unclassified
2. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
3. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
4. Patients with access to Mynexuzhealth via smartphone or internet
5. Patients must fluently speak, write, read Dutch.
6. 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
7. Patients having access to mynexuzhealth (plexus hospitals) or HiX (ZOL)
8. 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\*
9. Patients willing to go to their general practitioner or a hospital close by to perform a blood test every year\*
10. 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).

Exclusion Criteria:

Participants eligible for this Trial must not meet any of the following criteria:

1. Patients receiving an intravenous biological therapy or any form of corticosteroids (with the exception of inhaled or dermatological corticosteroids) in the last two years,
2. Patients with a change in concomitant IBD therapies in the last two years (except for rectal therapies),
3. Patients with IBD-related surgery in the past two years,
4. 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, ...)
5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
6. 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.

Primary outcomes:
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.
timeFrame: Two years
Secondary outcomes:
measure: Costs and cost savings for hospital, RIZIV, employer, patient, … in the intervention group versus the control group.
timeFrame: Two years
measure: Time saving for patients in the intervention group versus the control group will be measured using a "timing questionnaire".
timeFrame: Two years
measure: Number of telephone/email contacts with the IBD team within one year and within two years.
timeFrame: Two years
measure: Number of contacts with the general practitioner for IBD related reasons within one year and within two years.
timeFrame: Two years
measure: 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.
timeFrame: Two years
measure: 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.
timeFrame: Two years
measure: Number of patients refusing to participate in this trial and the reason why.
timeFrame: Two years
measure: Reasons to stop remote monitoring.
timeFrame: Two years
measure: Patient's compliance, measured via missing data in the intervention versus the control group
timeFrame: Two years
measure: Satisfaction with the program in the intervention group.
timeFrame: Two years
measure: System usability in the intervention group.
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
affiliation: UZ Leuven
name: Marc Ferrante
role: PRINCIPAL_INVESTIGATOR
References: