Evaluation of the SMART IBD App in Pediatric IBD
Not applicable · Testing SMART-IBD · 1 site · Children's Hospital Medical Center, Cincinnati
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing SMART-IBD (a behavioral program) as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease (IBD), IBD (Inflammatory Bowel Disease) and IBD - Inflammatory Bowel Disease.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 13 to 17
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- Start date: 2025-10-23.
- Main results expected around 2027-02-28 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Medication adherence (6 months)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD); IBD (Inflammatory Bowel Disease); IBD - Inflammatory Bowel Disease; Ulcerative Colitis (UC); Indeterminate Colitis; Crohn Disease (CD); IBD |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Enrollment | 70 (estimated) |
| Start date | 2025-10-23 |
| Primary completion (est.) | 2027-02-28 |
| First posted | 2025-09-26 |
| Last updated | 2025-11-21 |
| Official title | Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT07195123 |
Interventions
- SMART-IBD (Behavioral)
Daily medication and diary completion reminders are provided to participants. Additional psychoeducational content regarding self-management skills will be provided in-app.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.