TOD-IBD: Empowering Patients On-Demand

NCT06179563 | Enrolling By Invitation

• 1 other identifier: NL86106.100.24
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 2

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.

Conditions

Inflammatory Bowel Diseases; Telemonitoring; Patient Empowerment; Self Efficacy

Keywords

Monitor IBD At Home; Fecal Calprotectin; On-Demand; Appropriate Care

Outcome Measures

Primary Outcomes (1)

• Persistent Flares

  The primary study parameter is the cumulative incidence of persistent flares, defined as a flare for a consecutive period of ≥ 12 weeks during the study period. A flare is defined as: * The presence of faecal calprotectin more than 250 μg/g on two consecutive FCP-measurements collected at 12 weeks apart and; * MIAH score above 0.354215 (ulcerative colitis) or 0.3623618 (Crohn's disease) and least once during the period of 12 weeks.

  12 months

Secondary Outcomes (11)

• Number of contacts with healthcare provider

  12 months

• Disease activity from patient perspective

  12 months

• Disease activity from clinical perspective as number of flares

  12 months

• Generic quality of life

  12 months

• Generic quality of life and costs

  12 months

Study Arms (2)

Standard telemonitoring

NO INTERVENTION

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.

On-Demand Telemonitoring

EXPERIMENTAL

Patients will have the flexibility to use the telemonitoring application at their own discretion

Other: On-Demand Telemonitoring

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.

On-Demand Telemonitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Franciscus Gasthuis: lead
• Jeroen Bosch Ziekenhuis: collaborator

Study Sites (2)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5223GZ, Netherlands

Location

Franciscus

Rotterdam, South Holland, 3045PM, Netherlands

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Patient Participation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, multicentre, randomized controlled trial

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 22, 2023
• Study Start: March 26, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)