NCT07195123 Evaluation of the SMART IBD App in Pediatric IBD
| NCT ID | NCT07195123 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Inflammatory Bowel Disease (IBD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-10-23 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07195123 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Inflammatory Bowel Disease (IBD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07195123 currently recruiting?
Yes, NCT07195123 is actively recruiting participants. Contact the research team at kevin.hommel@cchmc.org for enrollment information.
Where is the NCT07195123 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT07195123 clinical trial?
NCT07195123 is sponsored by Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 70 participants.