Remote Monitoring for Inflammatory Bowel Disease

(ASSIST Trial)

Not currently recruiting at 4 trial locations

Overseen By Millie D Long, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Oral corticosteroids

Disqualifiers: Ileostomy, Colostomy, Imminent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

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

I am starting a new pill or injection treatment for my bowel disease.

Exclusion Criteria

I have symptoms of poor blood flow in my limbs.

Uncontrolled medical or psychiatric disease at the opinion of the investigator

I have a stoma or a surgical connection between my intestine and anus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and Training

Participants complete informed consent, baseline survey, and receive virtual training on the digital health system

1-2 weeks

1 virtual visit

Treatment

Participants use the remote monitoring digital health system to track medication adherence and report outcomes

12 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Remote Monitoring Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Synchronyx, LLC

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

A study involving 10 adult patients with ulcerative colitis showed high acceptance of the home automated telemanagement (UC HAT) system, with 90% of participants willing to use it in the future, indicating its potential for improving patient engagement and adherence to treatment.

Patients found the UC HAT system easy to use and reported that it could enhance monitoring of their symptoms and side effects, suggesting that it may lead to better clinical outcomes and increased patient satisfaction in managing ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home telemanagement for patients with ulcerative colitis (UC HAT). Cross, RK., Cheevers, N., Finkelstein, J.[2021]

The Tappt digital health system is designed to monitor real-time medication adherence in patients with inflammatory bowel diseases (IBDs) using smart label technology, which could help identify and address reasons for nonadherence.

A 12-month randomized controlled trial will assess the effectiveness of this system in improving medication adherence, clinical outcomes, and healthcare use compared to standard care, with an expected enrollment of 123 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and Persistence With Inflammatory Bowel Disease Therapy (ASSIST Study): Protocol for a Randomized Controlled Trial. Axelrad, J., Long, M., Horst, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12363004/

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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589750024002905

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- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11676731/

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 ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06338930

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 ...

5. wjgnet.com wjgnet.com/1007-9327/full/v29/i7/1139.htm

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8987011/

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.

7. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500%2824%2900290-5/fulltext

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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10011957/

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 ...

9. dldjournalonline.com dldjournalonline.com/article/S1590-8658(23)00667-9/fulltext

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 ...