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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 belowSelect...
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
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 moreAwards & 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.
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.
Find a Location
Who is running the clinical trial?
University of California, DavisOTHER
945 Previous Clinical Trials
4,755,526 Total Patients Enrolled
Northwestern UniversityOTHER
1,649 Previous Clinical Trials
958,157 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
909 Previous Clinical Trials
541,546 Total Patients Enrolled
The Cleveland ClinicOTHER
1,056 Previous Clinical Trials
1,371,003 Total Patients Enrolled
RxHealthUNKNOWN
Ashish Atreja, MD, MPHPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
320 Total Patients Enrolled
Bruce Sands, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
282 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Inflammatory Bowel Disease.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Digital Transformation Network (DTN) Program
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.