Digital Medicine for Inflammatory Bowel Disease

Recruiting at 5 trial locations

Overseen By Drew Helmus, MPH, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Advanced dementia, others

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

Compensation: Varies

Number of Visits: 1

614 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Digital Transformation Network (DTN) Program treatment for Inflammatory Bowel Disease?

Research shows that digital health technologies, like the HealthPROMISE app, can help reduce emergency room visits and hospitalizations for patients with inflammatory bowel disease by improving self-management and understanding of the condition. ^{1 2 3 4 5}

Is the Digital Medicine for Inflammatory Bowel Disease treatment safe for humans?

The studies reviewed do not report any specific safety concerns related to the use of digital health technologies for managing inflammatory bowel disease. These technologies, including telemedicine and digital health monitoring platforms, have been generally well-received by patients and are associated with improved quality of life and reduced healthcare resource use. ^{1 2 3 4 6}

How is the Digital Transformation Network (DTN) Program treatment different from other treatments for inflammatory bowel disease?

The Digital Transformation Network (DTN) Program is unique because it uses digital health technologies to remotely monitor and manage inflammatory bowel disease, focusing on improving treatment adherence and quality of life through real-time data collection and personalized interventions, unlike traditional treatments that may not offer such comprehensive remote monitoring and support. ^{1 2 4 5 7}

What is the purpose of this trial?

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.

Research Team

Bruce Sands, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Inflammatory Bowel Disease.

Ability to speak or understand English or Spanish Language.

Exclusion Criteria

Condition or disease that, in the opinion of the investigators, may make it exceedingly difficult for the patient to use DTN, including, but not limited to, advanced dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Establish baseline levels of digital connectivity, disease control, quality of life, and care metrics in cohorts at the three IBD centers

4 weeks

1 visit (in-person), multiple assessments (remote)

Intervention

Implement and evaluate precision-matched interventions among 1500 patients with IBD using a stepped-wedge, cluster-randomized trial

12 months

Ongoing remote monitoring and periodic in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Digital Transformation Network (DTN) Program

Trial Overview 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.

Participant Groups

Group I: Digital Transformation Network (DTN) Program Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

RxHealth

Collaborator

Trials

1

Recruited

610+

Findings from Research

Digital health technologies, such as web-based interventions and mobile applications, can reduce health care utilization and costs for patients with inflammatory bowel diseases (IBD), based on a review of 14 randomized controlled trials involving a median of 98 patients.

However, these digital interventions do not significantly improve disease activity, quality of life, or treatment adherence compared to standard care, indicating that while they may help manage costs, they do not enhance overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health Technologies for Remote Monitoring and Management of Inflammatory Bowel Disease: A Systematic Review. Nguyen, NH., Martinez, I., Atreja, A., et al.[2023]

A pilot study involving 15 participants showed that using patient-reported outcomes measures (PROMs) through an electronic platform for self-management in IBD care was well-accepted, with 10 participants feeling 'well' or 'well with questions'.

The implementation of PROMs in outpatient settings allowed for real-time tracking of quality of life and disease activity, enabling remote management of well patients and potentially increasing efficiency in outpatient services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using e-health tools and PROMs to support self-management in patients with inflammatory bowel disease. Avery, P.[2022]

The use of the HealthPROMISE digital health monitoring platform led to a significant reduction in IBD-related emergency room visits and hospitalizations, decreasing from 25% to 3% among patients who logged into the app at least once during the study.

Patients reported improved understanding of their condition after using the app, indicating that digital health tools can enhance patient education and engagement, although no significant changes were observed in quality indicators or symptom scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Digital Health Monitoring in the Management of Inflammatory Bowel Disease. Zhen, J., Marshall, JK., Nguyen, GC., et al.[2022]

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]

A review of 68 articles identified 11 digital health apps specifically for inflammatory bowel disease (IBD), which primarily focus on patient-reported outcomes and education, showing significant benefits in quality of life and treatment adherence without any reported negative impacts.

While digital health apps can enhance standard clinical care for IBD patients, further validation and research are needed to optimize their effectiveness and integration into healthcare, particularly through innovative methods like microrandomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health Apps in the Clinical Care of Inflammatory Bowel Disease: Scoping Review. Yin, AL., Hachuel, D., Pollak, JP., et al.[2023]

Out of 1,512 mobile health apps identified for inflammatory bowel disease (IBD), only six met the criteria for quality and relevance, highlighting a gap in effective self-management tools for diet and lifestyle.

The apps 'My IBD Care: Crohn's and Colitis' and 'LyfeMD' received the highest ratings for quality and functionality, including behavior tracking, suggesting they may be beneficial for patients managing IBD, but their actual impact on health outcomes needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and Evaluation of Mobile Applications for Self-Management of Diet and Lifestyle for Patients with Inflammatory Bowel Disease. Gold, SL., Chiew, BA., Rajagopalan, V., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Digital Health Technologies for Remote Monitoring and Management of Inflammatory Bowel Disease: A Systematic Review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Using e-health tools and PROMs to support self-management in patients with inflammatory bowel disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of Digital Health Monitoring in the Management of Inflammatory Bowel Disease. [2022]

4. Canada 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. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Digital Health Apps in the Clinical Care of Inflammatory Bowel Disease: Scoping Review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Current Landscape of Telemedicine Practice in Inflammatory Bowel Disease. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Identification and Evaluation of Mobile Applications for Self-Management of Diet and Lifestyle for Patients with Inflammatory Bowel Disease. [2023]