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Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management

NCT06424769 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2025-11-04

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether IBD patients have better disease outcomes and feel more empowered to manage their condition if they have access to text messaging with their clinical team and if their symptoms are more regularly monitored through text-based surveys.

Researchers will compare participants who have access to text-based monitoring, communication and education to participants who have access to text-based education alone. Researchers will also examine if different social and other non-medical factors impact IBD symptoms and quality of life.

All participants will:

* complete 5 brief on-line surveys over 12 months about their IBD and social risk factors,
* receive IBD education content by text message up to 2 times a week.

Some participants will also:

* receive additional surveys by text to monitor their IBD progression,
* have the opportunity to directly text message their IBD medical team.

Conditions

Interventions

OTHER

Enhanced Digital Care

Participants will receive brief check-in surveys about their IBD symptoms once a month, via text messaging. If the survey response indicates significant symptoms, an alert will be sent to the participant's IBD care team and participant will receive more frequent surveys (weekly) over the next month. Participants and their IBD clinical team will be able to communicate by text for non-emergency IBD-related questions.

OTHER

Education

Participants will receive education texts about IBD from trusted sources approximately twice a week. Topics will include: diet, medication adherence, fatigue, preventative care and other relevant issues.

Sponsors & Collaborators

Principal Investigators

  • Michael D Kappelman, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-24
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06424769 on ClinicalTrials.gov