Evaluation of the SMART IBD App in Pediatric IBD

NCT07195123 | Recruiting DMC

• 1 other identifier: SMART-IBD R21 RCT
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

IBD; Inflammatory Bowel Disease; Ulcerative Colitis; Indeterminate Colitis; Crohns Disease

Outcome Measures

Primary Outcomes (1)

• Medication adherence

  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.

  6 months

Secondary Outcomes (3)

• Disease Activity

  6 months

• Sleep Duration

  6 months

• Stress

  6 months

Study Arms (2)

SMART-IBD App

EXPERIMENTAL

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.

Behavioral: SMART-IBD

Attention Control

NO INTERVENTION

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.

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.

SMART-IBD App

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Kevin Hommel, PhD

CONTACT

513-803-0407; kevin.hommel@cchmc.org

Jessica King, BA

CONTACT

513-803-0920; jessica.king1@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study PI, statistician, co-investigators, and all personnel who are involved in endpoint analyses will be blinded. Only study coordinators will have access to the assignment of each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 26, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

US (1)