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TOD-IBD: Empowering Patients On-Demand

NCT06179563 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2025-08-21

No results posted yet for this study

Summary

Crohn's disease and Ulcerative Colitis, collectively known as Inflammatory Bowel Disease (IBD), impose a significant burden on patients and healthcare systems due to their chronic nature and complex treatment. This study aims to assess the effectiveness and safety of on-demand telemonitoring, as opposed to standard fixed-schedule telemonitoring, in managing IBD. The primary objective is to evaluate the impact of on-demand telemonitoring on the number of persistent flares over 12 months. The study involves a multicenter randomized controlled trial comparing standard telemonitoring, which includes regular completion of the Monitor IBD At Home questionnaire and fecal calprotectin home tests, with on-demand telemonitoring where patients use the app based on their symptoms. The study population includes adult patients with stable remission on maintenance therapy. Disease activity, measured by unplanned healthcare contacts, is the primary outcome, while secondary outcomes encompass clinical and patient-reported disease activity, quality of life, self-efficacy, patient activation, total healthcare contacts, safety, and costs. Baseline characteristics include patient, disease, and socio-demographic factors. This innovative approach has the potential to enhance patient autonomy, satisfaction, and self-management, while reducing the overall burden on the healthcare system.

Conditions

  • Inflammatory Bowel Diseases
  • Telemonitoring
  • Patient Empowerment
  • Self Efficacy

Interventions

OTHER

On-Demand Telemonitoring

Patients assigned to the on-demand intervention group do not have to use the app at set time intervals but will be asked to use the app at their own discretion, in case of symptoms. This implies that patients have full control over their monitoring activities. Patients have the option to reach out to the hospital whenever they feel the need.

Sponsors & Collaborators

  • Jeroen Bosch Ziekenhuis

    collaborator OTHER

  • Franciscus Gasthuis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2027-07-01
Completion
2028-03-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06179563 on ClinicalTrials.gov