New Clinical Trial Will Test Remote Monitoring to Better Manage Inflammatory Bowel Disease

UM School of Medicine Researchers Aim to Improve Medication Adherence and Reduce Dangerous Flare Ups

University of Maryland School of Medicine (UMSOM) researchers opened recruitment this month to assess whether a novel remote therapeutic monitoring system can help people with inflammatory bowel disease (IBD) adhere to their medication regimen, and ultimately improve their symptoms and prevent dangerous flare-ups. The study, called ASSIST, will recruit 123 participants for a randomized controlled trial that will involve IBD patients from the University of Maryland Medical Center and four other IBD centers.

IBD, which includes Crohn’s disease and ulcerative colitis, affects over 3 million adults in the United States. It is a chronic disease with flares that cause diarrhea, rectal bleeding, abdominal pain, and fatigue. To control symptoms and prevent relapses, patients need to take medications regularly, but research suggests 40 to 80 percent do not adhere to their drug regimens.

“Remote monitoring, a form of telemedicine, is a potential strategy to improve adherence,” said study lead Principal Investigator Raymond Cross, MD, MS, Professor of Medicine and Director of the IBD Program at UMSOM. “Many patients need ongoing support to remind them to continue medical therapy and to monitor for new or worsening symptoms or adverse effects of treatment. During symptom-free periods, it can be tempting to stop taking the medications that are keeping them well.”

Participants in the study will be randomly assigned to have remote monitoring or their usual care. The remote monitoring group will be provided with smart labels to attach to the container of their newly prescribed medications. They will also receive training on how to attach and use the labels, set up their profile, use the patient-facing web app, access educational resources, and get technical support. The web app allows participants to review their medication adherence, provide updates on their symptoms, and respond to questions to identify any challenges they experience that interfere with medication use, and unique barriers to care.

Most importantly, study investigators will receive alerts if patients are not taking their medication regularly or have an increase in symptoms. These patients will be contacted by a healthcare provider to determine solutions for improving their care.

“We want to determine whether patients in the remote monitoring group achieve better adherence to their medication and better overall outcomes with their inflammatory bowel disease compared to those receiving their usual care,” said Dr. Cross who is a gastroenterologist at UMMC.

Researchers at New York University, the University of North Carolina, Vanderbilt University, and the University of Cincinnati are also involved in this study. The research is funded by the Crohn’s and Colitis Foundation. Synchronyx, a health technology company, is providing the remote monitoring system for the study.

"This clinical research study will provide us with important information on whether a novel remote monitoring strategy improves overall treatment adherence which has been linked to improved outcomes in inflammatory bowel disease and other chronic illnesses,” said Mark T. Gladwin, MD, Vice President for Medical Affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, UMSOM. “Low-cost interventions such as those proposed in this study have the ability to prevent unnecessary healthcare utilization such as unplanned office visits, emergency room visits, and hospitalizations.”

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world – with 46 academic departments, centers, institutes, and programs, and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.3 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic, and clinically based care for nearly 2 million patients each year. The School of Medicine has nearly $600 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 students, trainees, residents, and fellows. The combined School of Medicine and Medical System (“University of Maryland Medicine”) has an annual budget of over $6 billion and an economic impact of nearly $20 billion on the state and local community. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity (according to the Association of American Medical Colleges profile) is an innovator in translational medicine, with 606 active patents and 52 start-up companies. In the latest U.S. News & World Report ranking of the Best Medical Schools, published in 2021, the UM School of Medicine is ranked #9 among the 92 public medical schools in the U.S., and in the top 15 percent (#27) of all 192 public and private U.S. medical schools. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu