Randomized Controlled Trial Comparing Remote Patient Monitoring vs Standard Care in IBD Patients Initiating or Changing Advanced Therapy

Sponsor
Resilience
Study ID
NCT07043036
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • GutyCare — DEVICE
    Device : GutyCare The participants will use GutyCare remote patient monitoring.

Study Details

This clinical trial aims to evaluate whether GutyCare, a digital remote patient monitoring (RPM) solution, can enhance organizational outcomes while maintaining non-inferior clinical results in patients with inflammatory bowel disease (IBD) who are initiating or undergoing significant modifications in advanced therapy. The study compares standard care to an intervention involving the use of GutyCare, a mobile application that collects patient-reported outcomes related to symptoms. When clinically significant symptoms are identified, alerts are transmitted to the care team, facilitating timely and personalized therapeutic adjustments.

Key Dates

Start date
Jun 30, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intervention/Treatment
  • No Intervention: Control

Primary Outcome Measure

Number of on-site IBD-related visits [ Time Frame: 12 months ]

Central Contacts

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