protocolSection identificationModule nctId: NCT06338930, orgStudyIdInfo id: ROADMAP, briefTitle: Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy, acronym: ROADMAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-03-02, completionDateStruct date: 2027-03-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Crohn Disease, conditions: Colitis, Ulcerative, conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 456, type: ESTIMATED, armsInterventionsModule interventions name: Remote monitoring, outcomesModule primaryOutcomes 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., secondaryOutcomes measure: Costs and cost savings for hospital, RIZIV, employer, patient, … in the intervention group versus the control group., secondaryOutcomes measure: Time saving for patients in the intervention group versus the control group will be measured using a "timing questionnaire"., secondaryOutcomes measure: Number of telephone/email contacts with the IBD team within one year and within two years., secondaryOutcomes measure: Number of contacts with the general practitioner for IBD related reasons within one year and within two years., secondaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes measure: Number of patients refusing to participate in this trial and the reason why., secondaryOutcomes measure: Reasons to stop remote monitoring., secondaryOutcomes measure: Patient's compliance, measured via missing data in the intervention versus the control group, secondaryOutcomes measure: Satisfaction with the program in the intervention group., secondaryOutcomes measure: System usability in the intervention group., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False