Actively Recruiting
Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-11-21
70
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the SMART-IBD smartphone app in improving medication adherence and self-management skills in adolescents aged 13 to 17 years with Inflammatory Bowel Disease (IBD), including Crohn's Disease, ulcerative colitis, or indeterminate colitis. This randomized controlled trial compares 35 youth using the app with 35 youth in an attention control group who will only complete daily symptom diaries. The study is conducted by the Children's Hospital Medical Center, Cincinnati. Participants in the experimental group will use the SMART-IBD app, which provides daily medication and diary reminders, educational content about self-management, and monthly engagement challenges focusing on adherence, sleep, and diary use. The control group will complete daily symptom diaries without receiving the app's intervention content. The study includes one month of baseline symptom and adherence diary collection, followed by a baseline assessment, five months of intervention or control activities, and a post-treatment assessment. Throughout the study, participants will complete daily symptom diaries and monthly assessments related to medication adherence, disease activity, sleep duration, and stress over six months. The research team will monitor adherence and other health outcomes using these measures. Participants must have internet access and a smartphone to engage with the app and regularly complete diaries and assessments during the five-month intervention period and follow-up visits.
CONDITIONS
Brief Title
Evaluation of the SMART IBD App in Pediatric IBD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of IBD (Crohn's Disease, ulcerative colitis, or indeterminate colitis)
- Prescribed at least one daily or weekly medication for treatment of IBD
- Medication adherence less than 86%
- Access to internet via Wi-Fi or data plan and access to a smartphone
- English fluency for patient and caregiver
You will not qualify if you...
- Diagnosis of pervasive developmental disorder in patient or caregiver
- Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants complete daily symptom diaries for one month prior to starting the intervention.
Daily diary entries
Duration - 5 months
Participants use the SMART-IBD app or serve as attention controls. The app provides medication reminders, educational content, and monthly engagement challenges. Participants complete daily symptom diaries during this period.
Daily diary entries and monthly app challenges
Duration - 1 visit
Participants complete assessments after the intervention period to evaluate outcomes.
1 visit (in-person or remote)
Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
K
Kevin Hommel, PhD
J
Jessica King, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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