Remote Monitoring for Inflammatory Bowel Disease
(ASSIST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a remote monitoring system designed to help people with inflammatory bowel disease (IBD) manage their medication and symptoms more effectively. Researchers aim to determine if this digital system improves patient adherence to treatment plans and leads to better health outcomes compared to usual care. Individuals with IBD who are starting a new oral or subcutaneous treatment and have access to a smartphone may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance IBD management for many.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants will be starting a new oral or subcutaneous treatment for inflammatory bowel disease.
What prior data suggests that this remote monitoring system is safe for patients with inflammatory bowel disease?
Research has shown that remote monitoring for inflammatory bowel disease (IBD) is generally safe and helpful. One study found that digital health tools for tracking IBD can shorten periods of discomfort. Another study found that symptoms were less severe with remote monitoring.
These findings suggest that patients widely accept this type of monitoring. Major reports of serious side effects from these digital tools have not emerged. While more research is always useful, current evidence suggests that remote monitoring is a safe option for managing IBD.12345Why are researchers excited about this trial?
Researchers are excited about the remote monitoring approach for inflammatory bowel disease (IBD) because it leverages technology to enhance patient adherence and symptom tracking. Unlike the standard care that relies on regular clinic visits and calls, this method uses smart labels and mobile notifications to remind patients about their medication schedule, ensuring better adherence. It actively engages patients with daily reminders and alerts the research team if symptoms worsen, offering a proactive way to manage IBD. This innovative approach could lead to more timely interventions and improve overall disease management.
What evidence suggests that this remote monitoring system is effective for inflammatory bowel disease?
This trial will compare remote monitoring with standard care for people with inflammatory bowel disease (IBD). Studies have shown that remote monitoring can improve health for people with IBD. For example, digital health tools can reduce flare-ups and simplify IBD management. Research on digital tools in IBD care has demonstrated better health outcomes. Specifically, one study found that telemonitoring (remote health tracking) improved patient outcomes and simplified condition management. Overall, remote monitoring appears to be a promising method for helping people with IBD manage their symptoms more effectively.26789
Are You a Good Fit for This Trial?
Adults with documented Inflammatory Bowel Disease (IBD) starting a new oral or subcutaneous treatment, who own a modern smartphone and can understand English. Excluded are those with certain medical conditions like serious infections, recent surgery plans, some heart diseases, mental health issues not well controlled, or specific bowel surgeries.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline and Training
Participants complete informed consent, baseline survey, and receive virtual training on the digital health system
Treatment
Participants use the remote monitoring digital health system to track medication adherence and report outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Remote monitoring
Trial Overview
The trial is testing if using a remote monitoring digital system for one year helps patients with IBD stick to their medication schedules better than the usual care does. It also looks at whether this system improves overall health outcomes and reduces the need for healthcare services.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
At the time of a medication dose, participants scan the smart label by tapping it with their mobile device. Participants receive a notification on their device indicating that their medication adherence was updated. Each day a medication is due, patients receive a morning reminder through SMS message notifying them on their medications schedule. If patients 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. Participants will also complete a patient reported outcome (PRO) 2 assessment at baseline, and then monthly for the entire 12 months of the study through an HTML link sent to patients by SMS message. If nonadherence is present and/or moderate to severe symptoms, an alert will be triggered to the research team. The research team can send the PRO2 survey to patients at any given time, at their discretion, if patients are experiencing a flare or at the time of a change in medication dose.
The standard of care for participants in this study is modeled after the standard of care at all five study sites. Standard of care is based on current evidence-based guidelines including a comprehensive assessment, a guideline-concordant therapy plan, scheduled and as needed clinic visits, scheduled and as needed telephone calls, and administration of educational fact sheets about disease-specific topics when appropriate. Personnel used to provide standard of care at each site will vary and may include nurse coordinators, advanced practice providers, social workers, psychologists, dieticians, pharmacists, and other ancillary staff.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Vanderbilt University Medical Center
Collaborator
University of Cincinnati
Collaborator
New York University
Collaborator
University of North Carolina, Chapel Hill
Collaborator
Synchronyx, LLC
Collaborator
Published Research Related to This Trial
Citations
Mobile health technologies in inflammatory bowel disease
Telemonitoring of Crohn's Disease and Ulcerative Colitis (TECCU) is a web-based tele-management system created by a research group in Spain for ...
Efficacy of digital health technologies in the management ...
In this umbrella review, we evaluated the effect of digital technologies on IBD care and patient outcomes. While digital technology contributes to reduced IBD- ...
TIGE-Rus (Telemonitoring for IBD Goodness Examination ...
Telemonitoring has been shown to be effective in improving outcomes for patients with IBD, and can provide a more convenient and accessible way ...
Remote Monitoring of Patients With an Inflammatory Bowel ...
During this two-year period, patients will be monitored remotely via three-monthly questionnaires (PRO-2, IBD disk, WPAI, EQ-5D-5L) and faecal calprotectin ...
Are we ready for telemonitoring inflammatory bowel ...
Web telemonitoring in IBD is safe and reduces the duration of disease flares[22]. Moreover, patients´ empowerment has been related to a ...
Digital Health Technologies for Remote Monitoring and ...
We performed a systematic review of digital health interventions in the management of patients with inflammatory bowel diseases (IBD) and evaluated its impact.
Efficacy of digital health technologies in the management ...
Clinical trials assessing available health tools for the management of patients with inflammatory bowel disease (IBD) are sparse, with limited ...
Are we ready for telemonitoring inflammatory bowel disease ...
Web telemonitoring in IBD is safe and reduces the duration of disease flares[22]. Moreover, patients´ empowerment has been related to a reduction in outpatient ...
Telemedicine in inflammatory bowel disease from its origin to ...
Greater improvement in disease activity and a larger reduction in fecal calprotectin values were noted with remote monitoring compared with the ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.