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)
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
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)
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.
Other
Prospective
Tappt
DeviceTappt 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.
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.
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.
Disease Activity Crohn's Disease
Harvey Bradshaw Index (Crohn's disease only)
Healthcare Utilization
For healthcare utilization, the investigators will use a composite endpoint including counts of hospitalizations, urgent care/emergency room visits, IBD-related surgeries, telephone calls (primary care and IBD provider), endoscopic procedures, imaging exams, and blood and stool testing. We will also assess new prescriptions for corticosteroids (prednisone and budesonide). Please note that this is a composite endpoint which will include counts of all events; thus, it is a single endpoint.
Quality of Life
PROMIS Global Health Scale PROMIS is a National Institutes of Health-funded instrument that assesses the patient's self-reported health over a 7-day time period. Patients report global health, different components of physical, mental, and social health, including physical function, anxiety, depression, fatigue, sleep disturbance, and pain interference, and higher scores indicate poorer health. PROMIS scores can be group grouped as within normal limits (\<55), mild (55 to \<60), moderate (60 to \<70), and severe (≥70) based on domain scores measured in the US general population (Kappelman, 2014; https://www.healthmeasures.net). Minimally important differences of 2 to 6 points have been reported for other disease states, including chronic pain, stroke, osteoarthritis, and cancer.
Anxiety
PROMIS Anxiety PROMIS is a National Institutes of Health-funded instrument that assesses the patient's self-reported health over a 7-day time period.48 Patients report global health, different components of physical, mental, and social health, including physical function, anxiety, depression, fatigue, sleep disturbance, and pain interference, and higher scores indicate poorer health. PROMIS scores can be grouped as within normal limits (\<55), mild (55 to \<60), moderate (60 to \<70), and severe (≥70) based on domain scores measured in the US general population (Kappelman, 2014; https://www.healthmeasures.net). Minimally important differences of 2 to 6 points have been reported for other disease states, including chronic pain, stroke, osteoarthritis, and cancer.
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Mercy Medical Center
Lead sponsor
Takeda
Collaborator
