Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338930
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-02-28
Brief Title:
Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROADMAP
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None