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Behavioural Intervention

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
Awards & highlights

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Patient Activation using PAM
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionFED
882 Previous Clinical Trials
22,474,085 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,543 Previous Clinical Trials
4,248,142 Total Patients Enrolled
University of PennsylvaniaOTHER
2,053 Previous Clinical Trials
43,012,227 Total Patients Enrolled
~600 spots leftby Sep 2028
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