Ulcerative Colitis Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Kevin Hommel, PhD
kevin.hommel@cchmc.org
513-803-0407
Backup
Jessica King, BA
jessica.king1@cchmc.org
513-803-0920
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 70
Treatments
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.
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov