University of Maryland Study Seeks Patients to Test Home Monitoring System for Inflammatory Bowel Disease
For immediate release: March 21, 2014
Baltimore, MD – Inflammatory bowel disease (IBD) specialists at the University of Maryland School of Medicine are recruiting patients for a study to determine whether a smartphone-based telemedicine system decreases disease activity and improves quality of life. The "TELE-IBD" study targets patients with a confirmed diagnosis of either ulcerative colitis, Crohn’s Disease or indeterminate colitis, who have had a flare-up in the last two years.
"We are getting better at treating Crohn's and colitis, but patient outcomes are still less than ideal. We anticipate that TELE-IBD will improve outcomes through more frequent monitoring, better adherence to medications, improved education, early detection of side effects, and more rapid initiation of medical therapy for a flare," says the study's principal investigator, Raymond Cross, MD, MS, AGAF, associate professor of medicine and director of the Inflammatory Bowel Disease Program at the University of Maryland School of Medicine and co-director of the Digestive Health Center at the University of Maryland Medical Center.
Inflammatory bowel diseases, comprised of ulcerative colitis and Crohn’s disease, are chronic, inflammatory conditions of the intestines that affect nearly 1.5 million people in the United States. When people have an IBD, their body’s immune cells attack the intestinal lining, causing inflammation and ulcerations, which can produce gastrointestinal symptoms such as diarrhea, rectal bleeding, abdominal pain and cramping. Ulcerative colitis and Crohn’s disease both affect young people, with the peak onset in the 20’s and 30’s, although they can affect children and older people.
Dr. Cross says the cause of IBD is speculative. “Genetics play a significant role, but other factors, including diet, the environment, antibiotics, smoking, anti-inflammatory drug use and the composition of bacteria in our intestines all may contribute to IBD.”
While there is currently no cure for IBD, Dr. Cross says existing medications are able to help alleviate symptoms and prevent flares of the disease. “A patient can have essentially a normal life on medical therapy. Nevertheless, their symptoms may affect them throughout their lifetime, with times of remission and other times of flares. The goals of our medical therapy are to eliminate flares, or if flares occur, to make them less severe than they’ve been in the past.”
A previous, pilot study confirmed that telemedicine technology to monitor patients with IBD is feasible and improved clinical outcomes. Researchers will be examining several potential benefits in this study: decreased disease activity; better quality of life; decreased utilization of health care services; improved patient education; decreased depression and anxiety; and improved patient self-management.
Patients will be randomized into three groups:
- No intervention: Patients will receive the current standard of care - routine and as-needed office visits and phone calls and education fact sheets from the Crohn’s and Colitis Foundation of America.
- Weekly home monitoring: Participants receive weekly text messages from the TELE-IBD system to answer questions about disease symptoms, side effects, to check body weight and to receive medication reminders and educational content. Participants receive action plans after each self-testing session. Alerts are generated to a nurse coordinator if certain clinical criteria are met.
- Bi-weekly home monitoring:Same as above, but every other week.
The goal is to enroll 375 participants. The estimated study completion date is October 2015.
More study details are at this link to the ClinicalTrials.gov website.
To learn how to enroll in the study, potential participants can call 410-706-3397 or 410-706-5943.
The University of Maryland is the sponsor of this study. Collaborators include the University of Pittsburgh, Vanderbilt University and the Agency for Healthcare Research and Quality, part of the U.S. Department of Health & Human Services.