Evaluation of the SMART IBD App in Pediatric IBD

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT07195123
Status
Recruiting
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Conditions

  • Crohn Disease (CD)
  • IBD
  • IBD (Inflammatory Bowel Disease)
  • IBD - Inflammatory Bowel Disease
  • Indeterminate Colitis
  • Inflammatory Bowel Disease (IBD)
  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 23, 2025
Status verified
Oct 2025
Primary completion
Feb 28, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SMART-IBD App
    The SMART-IBD app consists of educational content, medication reminders, and monthly app engagement challenges. App users will participate in 5 monthly challenges that focus on topics such as adherence, sleep, and diary usage. Participants in this arm will complete one month of run-in diaries, a baseline assessment, 5 months of intervention, including daily symptom diaries, and a post-treatment assessment.
  • No Intervention: Attention Control
    Participants in this arm will not receive any intervention content. Participants in this arm will complete one month of run-in diaries, a baseline assessment, 5 months of daily symptom diaries, and a post-treatment assessment.

Primary Outcome Measure

Medication adherence [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Kevin Hommel, PhD
[email protected]
513-803-0407
Jessica King, BA
[email protected]
513-803-0920
Kevin Hommel, PhD (PRINCIPAL_INVESTIGATOR)

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