SMART-IBD app for teens with inflammatory bowel disease
Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT07195123 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cincinnati, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.