Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
MONITOR
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)
2 other identifiers
observational
200
1 country
6
Brief 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:
- 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedStudy Start
First participant enrolled
May 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
May 8, 2025
May 1, 2025
1.4 years
December 2, 2024
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Medication Adherence
The primary outcome of the proposed study will be the difference in mean medication possession ratio (MPR) between intravenous and subcutaneous vedolizumab during the 22-week study. The mean MPR will be calculated as follows: MPR = number days' supply of medication obtained over observation period/total number days in observation period.
From enrollment to the end of the study (22 weeks).
Self Reported Medication Adherence
Self-reported adherence will be assessed with the MARS-5 questionnaire. MARS-5 is a reliable and validated instrument which includes five questions; responses are ranked on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item are summed to give a total score, with higher scores indicating higher levels of reported adherence.
From enrollment to the end of the study (22 weeks).
Secondary Outcomes (17)
Disease Activity Crohn's Disease
From enrollment to the end of the study (22 weeks).
Healthcare Utilization
From enrollment to the end of the study (22 weeks).
Quality of Life
From enrollment to the end of the study (22 weeks).
Anxiety
From enrollment to the end of the study (22 weeks).
Depression
From enrollment to the end of the study (22 weeks).
- +12 more secondary outcomes
Study Arms (1)
Participants with IBD receiving vedolizumab
Interventions
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.
Eligibility Criteria
Patients will be recruited for this study from seven clinical centers: Capital Digestive Care, MMC (lead site), New York University, Tulane University, University of North Carolina (data management center), University of Cincinnati, and Vanderbilt University. Of note, New York University has access to a disadvantaged population at NYC Health + Hospitals / Bellevue and a community site on Long Island.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mercy Medical Centerlead
- Takedacollaborator
Study Sites (6)
Tulane University
New Orleans, Louisiana, 70112, United States
Capital Digestive Care
Chevy Chase, Maryland, 20815, United States
New York University
New York, New York, 10016, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond K Cross, MD, MS
Mercy Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Center for Inflammatory Bowel and Colorectal Diseases
Study Record Dates
First Submitted
December 2, 2024
First Posted
December 27, 2024
Study Start
May 5, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
May 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After publication of the manuscript.
- Access Criteria
- See plan description above.
The raw data will be made available to other investigators upon receipt of a written request. Release of datasets to secondary users will be subject to approval by the investigators and Takeda. All approved users will be expected to enter into a standard data use agreement. The request must include a reason for review of the data and type of dataset they wish to receive (Microsoft® Excel Spreadsheet or SAS® dataset), and a copy of an up-to-date curriculum vitae. The dataset provided will be deidentified to prevent breach of research participant confidentiality. Further, even though the dataset will be deidentified to the greatest extent possible, investigators requesting to review our data must sign an agreement that they will not attempt to obtain protected health information on research participants. In addition to the raw data, investigators will receive a list of variable and coding definitions. Other information will be provided upon request.