Digital Medicine for Inflammatory Bowel Disease

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how digital tools, such as apps and remote monitoring, can improve care for people with Inflammatory Bowel Disease (IBD). The goal is to determine if these technologies can make healthcare more accessible and personalized when patients are not at the hospital. Participants will either use the Digital Transformation Network (DTN) Program or begin in a control group before transitioning to the DTN. Suitable candidates have been diagnosed with IBD and can communicate in English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions that could enhance patient care.

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 prior data suggests that this Digital Transformation Network (DTN) Program is safe for patients with Inflammatory Bowel Disease?

Research shows that digital health tools, such as the Digital Transformation Network (DTN) Program for managing inflammatory bowel disease (IBD), are generally safe. Studies have not identified any major safety issues with these tools, indicating that most users tolerate them well. Staying informed and reporting any unusual experiences is important, but current evidence supports the safety of these digital health solutions for IBD patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Transformation Network (DTN) Program for Inflammatory Bowel Disease (IBD) because it introduces a digital approach to managing the condition. Unlike traditional treatments that typically involve medication or surgery, the DTN Program leverages smartphone technology to engage patients in their own care. This real-time, digital interaction could enhance patient monitoring and treatment personalization, potentially leading to better outcomes. By integrating digital tools, researchers hope to find out if this method can improve the quality of life for IBD patients while reducing the need for more invasive interventions.

What evidence suggests that the Digital Transformation Network (DTN) Program is effective for Inflammatory Bowel Disease?

Research shows that digital health tools, such as apps and remote monitoring, effectively manage inflammatory bowel disease (IBD). Studies indicate these tools can reduce emergency room visits and hospital stays for people with IBD. In this trial, participants in the Digital Transformation Network (DTN) Program arm will experience these digital interventions. Digital programs enhance healthcare accessibility and improve overall health. Specifically, another study found that people using a digital health program felt more energetic. These findings suggest that digital tools can ease living with IBD and lead to better health outcomes. ^{3 6 7 8 9}

Who Is on the Research Team?

Bruce Sands, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10182451/

A New Digital Health Program for Patients With ... This study aimed to perform a preliminary program evaluation, analyzing engagement and preliminary effectiveness and the effect on participants' energy levels.

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

Efficacy of digital health technologies in the management ... Digital health technologies (DHTs) are increasingly used to support clinical care, increase accessibility to health care, and improve health ...

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

Mobile health technologies in inflammatory bowel disease IBD Qorus is a multicenter, prospective quality improvement program created by the Crohn's and Colitis Foundation to streamline and improve the ...

4. link.springer.com link.springer.com/article/10.1007/s10916-021-01706-x

Impact of Digital Health Monitoring in the Management ... This study demonstrated that digital health monitoring platforms may aid in reducing the number of ER visits and hospitalizations in IBD patients.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07159776

Multiple Digital Biomarkers for Optimization of IBD Care The trial aims to develop digital biomarkers based on a large dataset of imput data. These data come from diffent sources including wearable data, ...

6. withpower.com withpower.com/trial/phase-inflammatory-bowel-diseases-2021-f5cac

Digital Medicine for Inflammatory Bowel Disease The studies reviewed do not report any specific safety concerns related to the use of digital health technologies for managing inflammatory bowel disease. These ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/93/NCT04345393/ICF_000.pdf

Translating Scientific Evidence Into Practice Using Digital ... shared for future research unrelated to IBD or digital medicine tools / Digital Transformation Network. (DTN), even if the identifiable information is removed.

8. techtarget.com techtarget.com/searchhealthit/news/366579266/Orgs-Push-Digital-Medicine-EHR-Tool-to-Advance-Digestive-Health

Orgs Push Digital Medicine, EHR Tool to Advance Digestive Health “Through the creation of a Digital Transformation Network (DTN) for Inflammatory Bowel Disease (IBD), we plan to reduce digital disparities and ...

9. medcentral.com medcentral.com/gastroenterology/digital-ibd-outreach-improves-trial-recruitment-avoids-barriers

Digital IBD Outreach Improves Trial Recruitment, Avoids ... Of these, 63.3% identified as females, had a mean age of 42.1 ± 15.6 years, 75% were white, 39.0% had ulcerative colitis, and 60.6% had Crohn's ...