RecruitingNot ApplicableNCT07195123

Evaluation of the SMART IBD App in Pediatric IBD

Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

70 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

IBD (Inflammatory Bowel Disease)Inflammatory Bowel Disease (IBD)

Summary

The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in improving medication adherence and self-management skills in adolescents with IBD. The investigators will conduct a randomized control trial to compare 35 youth (ages 13-17) with IBD using an app that contains daily symptom diaries, education content, medication reminders, as well as monthly engagement challenges to 35 youth in an attention control group that will complete daily diaries. The length of the intervention will include one month of baseline symptom and adherence collection, a baseline assessment, 5 months of intervention, and a post-treatment assessment.

Eligibility

Min Age: 13 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a smartphone app called SMART IBD that sends reminders and educational content to help children and teenagers with inflammatory bowel disease (IBD) take their medications more consistently. **You may be eligible if...** - You (or your child) have a confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis, or indeterminate colitis) - You are prescribed at least one daily or weekly IBD medication - Your medication adherence is below 86% (you are missing some doses) - You have a smartphone and internet access (Wi-Fi or data) - You (and your caregiver) can speak and read English fluently **You may NOT be eligible if...** - You or your caregiver have been diagnosed with a pervasive developmental disorder (such as autism spectrum disorder) - You or your caregiver have been diagnosed with a serious mental illness such as schizophrenia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSMART-IBD

Daily medication and diary completion reminders are provided to participants. Additional psychoeducational content regarding self-management skills will be provided in-app.