Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy

Conditions

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Remote monitoring — OTHER
  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 Details

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.

Key Dates

First listed

Apr 1, 2024

Start date

Feb 1, 2025

Status verified

Feb 2024

Primary completion

Mar 2, 2027

Completion

Mar 30, 2027

Study Design

Enrollment

456 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Remote monitoring group
  This group will follow the remote monitoring programme.
• No Intervention: Control group
  This group will be monitored following the standard of care.

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 ]

Central Contacts

• Marc Ferrante
  016 342845
  [email protected]
• Stephanie Brams
  016348212
  [email protected]

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