Clinical trial NCT06179563: TOD-IBD: Empowering Patients On-Demand
Official title: Enhancing Patient Empowerment in Inflammatory Bowel Disease: The Role of On-Demand Telemonitoring
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Telemonitoring
Patient Empowerment
Self Efficacy
Keywords: Monitor IBD At Home
Fecal Calprotectin
On-Demand
Appropriate Care
Lead sponsor: Franciscus Gasthuis
Sponsor class: OTHER
Collaborators: name: Jeroen Bosch Ziekenhuis
First posted: 2023-12-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pragmatic, multicentre, randomized controlled tria
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Rationale: Crohn's disease and Ulcerative Colitis (Inflammatory Bowel Disease (IBD)) are chronic intestinal inflammations with significant impact on quality of life. Due to their chronic nature and complex treatment requiring regular outpatient appointments, IBD care puts a great burden on both the patient and the healthcare system. Appropriate care, as described in the Integrated Care Agreement published by the Dutch ministry of Health, is becoming increasingly important. Telemonitoring is a promising alternative to regular outpatient visits, with even evidence of improving the quality of care. We combined a clinical disease activity patient-reported outcome measure (the Monitor IBD At Home questionnaire) with a faecal calprotectin home test (SmarTest from Preventis) integrated in a new easy to use E-health application IBD Care Everywhere (IBD-CE) for IBD patients to determine disease activity at home.

In this study, we investigate whether using telemonitoring on-demand, according to individual needs, is equally effective and safe as telemonitoring based on a fixed schedule. This concept offers the opportunity to align the treatment of the disease more closely with the principles of appropriate care, which can result in improved patient autonomy, increased satisfaction, and enhanced self-management, while simultaneously reducing the burden on the healthcare system.

Objective: The primary objective is to assess the effect of on-demand telemonitoring for IBD patients on the number persistent flares for 12 months follow up.

Study design and intervention: This is a multicenter randomized controlled trial comparing on-demand telemonitoring with standard telemonitoring over a period of 12 months. Patients in the standard telemonitoring group follow the regular telemonitoring care pathway, which involves completing the Monitor IBD At Home (MIAH) questionnaire and performing a fecal calprotectin (FCP) home test. The app provides follow-up advice based on the results ofan algorithm. In the on-demand intervention group, patients can use the app at their own discretion when they experience symptoms but are not required to perform standard measurements when they are symptom-free. This allows them to have control over their monitoring activities.

Study population: Adult (\>18 years) patients with an established diagnosis of Crohn's disease or ulcerative colitis according to international guidelines, on maintenance therapy with no medication changes in the last three months and in stable remission. Remission will be defined as faecal calprotectin (FCP) \< 100 µg/g and Harvey Bradshaw Index (HBI) \< 5 for CD and as faecal calprotectin (FCP) \< 250 µg/g and Simple Clinical Colitis Activity Index scores (SCCAI) \< 3 for UC.

Study parameters/endpoints: Disease activity, defined as the number persistent flares, is the primary outcome measure. The secondary outcome measures include: clinical disease activity (number of flares), patient-reported disease activity (IBD-Control-8), quality of life (EQ-5D-5L, WIX, and SIBDQ), self-efficacy (IBD-SES), patient activation (PAM-13), total number of contacts with a healthcare provider, safety, and costs (healthcare costs, productivity costs, and patient costs). Baseline characteristics include patient, disease, and socio-demographic factors.

Eligibility criteria: Inclusion Criteria:

* Aged \>18 years.
* Confirmed IBD diagnosis according to current standards (37).
* Provided informed consent.
* Maintenance therapy with no medication changes in the last 3 months.
* Remission (17, 38)
* Crohn's disease: Faecal calprotectin (FCP) \< 100 µg/g and Harvey Bradshaw Index (HBI) \< 5 or MIAH-CD \< 0.3623618
* Ulcerative Colitis: Faecal calprotectin (FCP) \< 250 µg/g and Simple Clinical Colitis Activity Index scores (SCCAI) \< 3 or MIAH-CU \< 0.354215

Exclusion Criteria:

* Presence of a stoma.
* Presence of an ileo-anal pouch or ileorectal anastomosis.
* Participating in another prospective clinical trial that interferes with this trial.
* Have insufficient knowledge of the Dutch language to use the application.
* Do not have a smartphone or tablet with an internet connection.

Primary outcomes:
measure: Persistent Flares
timeFrame: 12 months
Secondary outcomes:
measure: Number of contacts with healthcare provider
timeFrame: 12 months
measure: Disease activity from patient perspective
timeFrame: 12 months
measure: Disease activity from clinical perspective as number of flares
timeFrame: 12 months
measure: Generic quality of life
timeFrame: 12 months
measure: Generic quality of life and costs
timeFrame: 12 months
measure: Disease specific quality of life
timeFrame: 12 months
measure: Self-efficacy
timeFrame: 12 months
measure: Patient Activation
timeFrame: 12 months
measure: Patient safety measured with variables retrieved from the hospital information system
timeFrame: 12 months
measure: Healthcare costs
timeFrame: 12 months
measure: Productivity costs
timeFrame: 12 months
Other outcomes:
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