What side effects are associated with this type of intervention?

Common treatments for Inflammatory Bowel Disease (IBD) include biologics, immunomodulators, and corticosteroids. Biologics, such as infliximab, can cause infusion reactions, infections, and rare instances of lymphoma. Immunomodulators like azathioprine may lead to bone marrow suppression, liver toxicity, and increased risk of infections. Corticosteroids are associated with weight gain, osteoporosis, hypertension, and increased susceptibility to infections. Digital tools used in the Digital Transformation Network (DTN) trial, such as apps and telemedicine, generally have minimal direct side effects but can sometimes lead to data privacy concerns and require reliable internet access.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Inflammatory Bowel Disease (IBD), including infliximab, adalimumab, vedolizumab, and golimumab, primarily for moderate to severe cases. Thiopurines and corticosteroids are also commonly used in combination therapies. The Digital Transformation Network (DTN) aims to leverage digital tools such as apps, remote monitoring, telemedicine, and patient-reported outcomes to provide individualized recommendations and improve population health in IBD management.

What other types of research exist?

Promising, novel alternatives to the Digital Transformation Network (DTN) for IBD patients in 2024 include: 1) Advanced telemedicine platforms that integrate AI for personalized treatment recommendations, 2) Wearable devices for continuous remote monitoring of vital signs and disease activity, 3) Mobile health apps with predictive analytics to anticipate flare-ups and optimize medication adherence, 4) Virtual reality (VR) tools for stress reduction and mental health support, and 5) Blockchain technology for secure and transparent patient data management.

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Digital Medicine for Inflammatory Bowel Disease

N/A

Waitlist Available

Led By Ashish Atreja, MD, MPH

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year after enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use digital tools like apps and remote monitoring to help people with Inflammatory Bowel Disease (IBD). By integrating these tools into a unified system connected to electronic health records, the study hopes to improve disease management and reduce emergency visits. The goal is to see if these digital methods can be widely adopted and benefit patients' health.

Who is the study for?

This trial is for adults over 18 with Inflammatory Bowel Disease (IBD) who can communicate in English or Spanish. It's not suitable for individuals with conditions like advanced dementia that would make using digital tools extremely challenging.

What is being tested?

The study is testing a Digital Transformation Network (DTN) Program designed to integrate digital medicine into everyday healthcare for IBD patients, aiming to improve care outside of traditional clinical settings.

What are the potential side effects?

Since this trial involves the use of digital tools and not medications, there are no direct medical side effects. However, participants may experience issues related to technology use such as privacy concerns or stress from learning new systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Number of Unplanned Acute Care

Number of Participants in Disease Control

Secondary study objectives

Digital Disparities Module

Generalized Anxiety Disorder scale (GAD-7)

Net Promoter Score

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Digital Transformation Network (DTN) ProgramExperimental Treatment1 Intervention

IBD patients at the 3 sites will be sent a message to their Smartphone

Group II: Control ArmActive Control1 Intervention

Patients will enter the control group once they initially complete the ePRO and online assessment tools. They will remain in the control group, and then at set intervals each site will transition these patients into the DTN intervention arm.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Inflammatory Bowel Disease (IBD) include 5-aminosalicylic acids (5-ASA), glucocorticoids, thiopurines, and biologics. 5-ASA agents, such as mesalamine, reduce inflammation in the gut lining by inhibiting the production of inflammatory chemicals. Glucocorticoids, like prednisone, suppress the overall immune response to decrease inflammation rapidly. Thiopurines, including azathioprine, modulate the immune system by interfering with DNA synthesis in immune cells, thereby reducing chronic inflammation. Biologics, such as anti-TNF agents, target specific proteins involved in the inflammatory process to prevent immune system overactivity. These treatments are essential for managing IBD as they help control symptoms, induce and maintain remission, and improve the quality of life. Leveraging digital tools like apps, remote monitoring, and telemedicine, as studied in the Digital Transformation Network (DTN) trial, can enhance the effectiveness of these treatments by providing individualized recommendations and continuous monitoring, leading to better disease management and patient outcomes.