TOD-IBD: Empowering Patients On-Demand

Sponsor
Franciscus Gasthuis
Study ID
NCT06179563
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • On-Demand Telemonitoring — OTHER
    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.

Study Details

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.

Key Dates

First listed
Dec 22, 2023
Start date
Mar 26, 2025
Status verified
Aug 2025
Primary completion
Jul 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
422 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Standard telemonitoring
    Patients will be monitored according to a fixed telemonitoring schedule at their treating hospitals, based on the patient's medication type and in adherence to national and international guidelines.
  • Experimental: On-Demand Telemonitoring
    Patients will have the flexibility to use the telemonitoring application at their own discretion

Primary Outcome Measure

Persistent Flares [ Time Frame: 12 months ]

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