RecruitingNCT06750731

Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention

Real World Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention (MONITOR Study)

Sponsor

Mercy Medical Center

Enrollment

200 participants

Start Date

May 5, 2025

Study Type

OBSERVATIONAL

Conditions

Ulcerative Colitis Inflammatory Bowel Disease (IBD)Crohn's Disease

Summary

The goal of this observational study is to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization in patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, and inflammatory bowel disease type undetermined) initiating therapy with vedolizumab (Entvyio). The main questions it aims to answer are: 1. Assess and compare adherence to intravenous (IV) and subcutaneous vedolizumab maintenance therapy in patients with IBD using a novel remote monitoring system. 2. Assess symptom response to vedolizumab post induction (week 6-8) and during maintenance therapy (week 22) using a novel remote monitoring system. 3. Assess time to response to vedolizumab during induction (weeks 0-6) using a novel remote monitoring system. Researchers will compare medication adherence between participants using IV and subcutaneous vedolizumab maintenance therapy to see if adherence is lower with self-administration. Participants will be asked to register adherence to medication using the novel remote monitoring system each time they take a dose of vedolizumab and to respond to two questions about bowel symptoms weekly for the first 6 weeks after starting vedolizumab then monthly thereafter for 6 months. Additionally, participants will be asked to enter information regarding demographics and social determinants of health at baseline and other variables listed below at baseline and at weeks 2, 6, 14, and 22 post baseline unless otherwise denoted: * MARS-5 * Healthcare utilization (22 weeks only) * Harvey Bradshaw Index (Crohn's disease only) * Simple clinical colitis activity index (Ulcerative colitis only) * PROMIS Global Health Scale * PROMIS Anxiety * PROMIS Depression * PROMIS Sleep Disturbance * PROMIS Pain Interference * PROMIS Physical Function * IBD Self-Efficacy * Attitudinal Survey (22 weeks only)

Eligibility

Min Age: 18 Years

Inclusion Criteria5

At least 18 years of age or older
Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology
Initiating treatment with vedolizumab
Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access
Ability to understand the protocol and provide informed consent in English or Spanish

Exclusion Criteria14

Inability to speak and read English or Spanish
Unable to comply with the study protocol including inability to access the internet and/or inadequate access to a smart device
Unable to access vedolizumab due to insurance restrictions
Unable to follow up at respective sites due to insurance restrictions or other barriers (i.e., distance from patient's home to study site)
Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis
Imminent surgery (within the next 60 days)
History of short bowel syndrome
Uncontrolled medical or psychiatric disease at the opinion of the investigator
Degenerative neurologic condition
Unstable angina
Symptomatic peripheral vascular disease
Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin)
Poorly controlled depression, mania, and schizophrenia
Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)

Interventions

DEVICETappt

Tappt is a web-based system designed to record participants medication taking behavior and bowel symptoms. Participants will be assigned smart labels for their specific vedolizumab regimen, which will be used by participants to record their vedolizumab use. Participants will be shipped smart labels to be affixed to an IV "card" for the first three infusions and for subsequent infusions or injections. At the time of a vedolizumab dose, participants will scan the smart label by tapping it with their mobile device to verify that they are taking the medication. Each day that vedolizumab is due, patients will receive a reminder through SMS message. If participants fail to scan the label at a given time (as expected by their specific medication regimen), they will receive an end of day text message reminder. Participants will also complete a patient reported outcome assessment at baseline, weekly for 6 weeks, and then monthly for the entire 22 weeks of the study triggered by the system.