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Digital Medicine for Inflammatory Bowel Disease

N/A

Recruiting

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

Study Summary

This trial will test whether digital medicine can improve outcomes for patients with Inflammatory Bowel Disease.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Number of Unplanned Acute Care

Number of Participants in Disease Control

Secondary outcome measures

Digital Disparities Module

Generalized Anxiety Disorder scale (GAD-7)

Net Promoter Score

+9 more

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

Find a Location

Who is running the clinical trial?

University of California, DavisOTHER

911 Previous Clinical Trials

4,707,941 Total Patients Enrolled

Northwestern UniversityOTHER

1,589 Previous Clinical Trials

915,548 Total Patients Enrolled

Icahn School of Medicine at Mount SinaiLead Sponsor

861 Previous Clinical Trials

523,698 Total Patients Enrolled

Media Library

Digital Transformation Network (DTN) Program Clinical Trial Eligibility Overview. Trial Name: NCT04345393 — N/A

Inflammatory Bowel Disease Research Study Groups: Digital Transformation Network (DTN) Program, Control Arm

Inflammatory Bowel Disease Clinical Trial 2023: Digital Transformation Network (DTN) Program Highlights & Side Effects. Trial Name: NCT04345393 — N/A

Digital Transformation Network (DTN) Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04345393 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many health care facilities have adopted this experiment?

"Currently, this trial is enrolling participants from 6 clinics across the country. These centres are geographically spread out and encompass Cleveland, New york City and Davis as well as 3 other locations. To reduce travel requirements for patients, it's best to pick a clinic closest to you should you choose to participate in the study."

Answered by AI

What is the primary objective of this clinical experiment?

"This clinical trial will primarily measure the number of participants in disease control over an allotted baseline period. Secondary outcomes include a Digital Disparities Module, Generalized Anxiety Disorder Scale (GAD-7), and PROMIS Global Scales which respectively assess digital connectivity, emotional wellbeing, and social functioning with standardized T-Scores ranging from 0 to 100."

Answered by AI

How many participants are being monitored as part of this clinical experimentation?

"Affirmative. The clinical trial was posted on May 14th, 2022 and subsequently edited on July 24th according to the information hosted on clinicaltrials.gov. Furthermore, 1578 participants are needed from 6 sites for this experiment."

Answered by AI

Is enrollment still ongoing for this clinical experiment?

"According to clinicaltrials.gov, this medical research is presently recruiting patients and was originally posted on May 14th 2022 with the most recent edits occurring July 24th of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes

Bruce E. Sands 2022. "Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04345393.