Digital Care for Inflammatory Bowel Disease (PROMOTE IBD Trial)

N/A

Recruiting

Led By Michael D Kappelman, MD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

13+ years old with IBD (Crohn's disease, ulcerative colitis, indeterminant colitis)

Must not have

IBD patients s/p surgery with a current pouch or ostomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial aims to see if patients with Inflammatory Bowel Disease (IBD) have better outcomes and feel more empowered if they can communicate with their clinical team through text messages and have their symptoms monitored

Who is the study for?

This trial is for individuals with Crohn's Disease, Ulcerative Colitis, or other forms of Inflammatory Bowel Disease. Participants should be willing to complete online surveys and receive educational content via text messages. The eligibility criteria are not fully listed here.

What is being tested?

The study tests if regular text-based symptom monitoring and communication with the clinical team can improve disease management in IBD patients compared to those only receiving educational texts. It also explores how social factors affect IBD symptoms and life quality.

What are the potential side effects?

Since this trial involves education and digital communication rather than medication, there are no direct medical side effects expected from participating in this study.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 13 or older and have IBD (Crohn's, ulcerative colitis, or indeterminant colitis).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have IBD and have had surgery resulting in a pouch or ostomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months 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 Patient Activation using PAM

Secondary study objectives

IBD-Related Quality of Life

Remission at 52 Weeks

Unplanned Healthcare Utilization

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Enhanced Digital Care ArmActive Control2 Interventions

Participants will receive brief check-in surveys about their IBD symptoms minimally once a month, via text messaging. Participants will also receive IBD educational text messages twice each week.

Group II: Specialized Education ArmPlacebo Group1 Intervention

Participants in this arm will receive IBD educational text messages twice each week.

0 / 2Eligibility criteria met