Evaluation of the SMART IBD App in Pediatric IBD

Not Applicable

Recruiting

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

• Registration Number: NCT07195123
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Study Start: 2025-09-30
• Primary Completion: 2027-02-28
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication adherence	6 months	Medication adherence will be measured by daily responses by participants to prompts in the SMART IBD app regarding whether each dose was taken for each medication. A mean adherence score will be calculated across medications for each participant for the 28 day periods at baseline and post-treatment.

Secondary Outcome Measures

Name	Time	Method
Disease Activity	6 months	PROs will be collected regarding composite disease activity comprised of fecal calprotectin, stool frequency, and rectal bleeding for ulcerative colitis and fecal calprotectin, stool frequency, and abdominal pain for Crohn's. Stool samples collected at baseline and post-assessment will also be utilized to assess diseases activity.
Sleep Duration	6 months	Sleep duration will be assessed via the SMART IBD App diary on a scale of 0-18 hours or more with half hour increments. Participants in both arms will report sleep duration via the diary.
Stress	6 months	Stress will be assessed via the SMART IBD App diary on a scale of 0-10, where 0 is no stress and 10 is highest stress. Participants in both arms will report stress via the diary.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States