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)Ulcerative Colitis (UC)Crohn Disease (CD)Inflammatory Bowel Disease (IBD)Indeterminate Colitis 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

Inclusion Criteria5

Confirmed diagnosis of IBD (Crohn's Disease, ulcerative colitis, or indeterminate colitis)
Prescribed at least one daily or weekly medication for treatment of IBD
\<86% adherence to prescribed medication
Access to internet via Wi-Fi or data plan and access to smartphone
English fluency for patient and caregiver

Exclusion Criteria2

Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review

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.