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NCT07195123Recruiting

Evaluation of the SMART IBD App in Pediatric IBD

Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
70 (estimated)
First submitted
17 Sept 2025
Start date
23 Oct 2025
Primary completion date
28 Feb 2027
Lead sponsor
Children's Hospital Medical Center, Cincinnati
NCT number
NCT07195123

What you commit to

  • Study type: Interventional
  • Planned participants: 70
  • From 23 Oct 2025 to the primary completion date, 28 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 13 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cincinnati Children's Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.