SMART-IBD app for teens with inflammatory bowel disease
Official title: Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease
Run by Children's Hospital Medical Center, Cincinnati · NCT07195123 · Data updated 2026-11-12
This will test whether the SMART-IBD smartphone app helps adolescents ages 13–17 with IBD take their medicines and manage symptoms better than completing daily diaries alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 13 Years to 17 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | October 23, 2025 |
| Main results expected | February 28, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07195123 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adolescents aged 13–17 with a confirmed diagnosis of IBD who are prescribed at least one daily or weekly IBD medication, have baseline adherence below 86%, have smartphone/internet access, and are English-fluent are ideal candidates.
✕Probably not a fit
Patients with good medication adherence (≥86%), no smartphone or internet access, non-English speakers, or those with pervasive developmental disorders or serious mental illness in the patient or caregiver are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial will compare the SMART-IBD smartphone app to an attention control among 70 adolescents with IBD (ages 13–17), randomized to app (n=35) or daily diary control (n=35). After a one-month baseline period of symptom and adherence tracking and a baseline assessment, participants use the assigned intervention for five months followed by a post-treatment assessment. The app includes daily symptom diaries, medication reminders, educational content, and monthly engagement challenges, while the control arm completes daily diaries only. Primary outcomes focus on medication adherence (eligibility requires baseline adherence <86%), with secondary outcomes including self-management skills and symptom measures.
Why it matters
Potential benefit: If effective, the app could improve medication adherence and self-management in teens with IBD, potentially reducing flares and healthcare utilization.
How similar studies have gone: Similar mobile health and reminder-based interventions in pediatric and adult chronic conditions have shown mixed but sometimes positive effects on adherence, and app-based approaches in pediatric IBD are promising though not yet widely proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States Recruiting
Study contacts
- Study coordinator: Kevin Hommel, PhD
- Email: kevin.hommel@cchmc.org
- Phone: 513-803-0407
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.