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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months, 22 weeks, 6 weeks
  • Procedures mentioned: Questionnaires, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The proposed study is a multicenter, open label, clinical trial to be conducted over 22 weeks."
  • "Additionally, participants will complete a two-item assessment of symptoms at baseline, weekly for 6 weeks, then monthly through week 22."
  • "Eligible patients will complete informed consent and a baseline survey gathering demographic and clinical information."
  • "Participants will be shipped smart labels to be affixed to an IV "card" for the first three infusions and for subsequent every 8 week infusions or every 2 week subcutaneous pen."
  • "Participants will also complete a patient reported outcome (PRO) 2 assessment at baseline, weekly for 6 weeks, and then monthly for the entire 22 weeks of the study triggered by the Tappt platform, through an HTML link sent to participants by SMS message."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with inflammatory bowel disease (IBD) who are starting vedolizumab. It compares how well people keep up with doses given through a vein or as a shot under the skin. It also checks whether a remote digital system can help track doses, bowel symptoms, and use of health care.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have confirmed IBD: Crohn’s disease, ulcerative colitis, or IBD of an unknown type.
  • You are starting treatment with vedolizumab.
  • You have an iPhone 7 or newer, or an Android phone released in 2012 or later, with reliable data or Wi-Fi.
  • You can understand the study and give informed consent in English or Spanish.

Who can't join

  • You cannot speak and read English or Spanish.
  • You cannot follow the study steps, including using the internet and a suitable smart device.
  • Insurance rules prevent you from getting vedolizumab.
  • Insurance rules, travel distance, or other barriers prevent follow-up visits at the study site.
  • You have an ileostomy or colostomy (a bowel opening in the belly), an internal bowel pouch connected to the anus, or surgery connecting the small bowel to the rectum.
  • You are expected to have surgery within the next 60 days.
  • You have had short bowel syndrome, when too little working small bowel remains to absorb nutrients well.
  • The study doctor finds that you have an uncontrolled medical or mental health condition. Listed conditions include a worsening nerve or brain condition; unstable heart-related chest pain; poor blood flow to the limbs that causes symptoms; cancer within 2 years, except basal or squamous cell skin cancer; poorly controlled depression, mania, or schizophrenia; or a serious active infection needing medicine, except Crohn’s disease around the anus treated with antibiotics.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. At least 18 years of age or older 2. Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology 3. Initiating treatment with vedolizumab 4. Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access 5. Ability to understand the protocol and provide informed consent in English or Spanish Exclusion Criteria: 1. Inability to speak and read English or Spanish 2. Unable to comply with the study protocol including inability to access the internet and/or inadequate access to a smart device 3. Unable to access vedolizumab due to insurance restrictions 4. Unable to follow up at respective sites due to insurance restrictions or other barriers (i.e., distance from patient's home to study site) 5. Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis 6. Imminent surgery (within the next 60 days) 7. History of short bowel syndrome 8. Uncontrolled medical or psychiatric disease at the opinion of the investigator 1. Degenerative neurologic condition 2. Unstable angina 3. Symptomatic peripheral vascular disease 4. Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin) 5. Poorly controlled depression, mania, and schizophrenia 6. Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)

Study sites (6)

LA

MD

NC

NY

OH

TN