Recruiting

SMART-IBD

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07195123

Conditions

Inflammatory Bowel Disease (IBD)

IBD (Inflammatory Bowel Disease)

IBD - Inflammatory Bowel Disease

Ulcerative Colitis (UC)

Indeterminate Colitis

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

SMART-IBD

Study Details

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)

IBD - Inflammatory Bowel Disease

Ulcerative Colitis (UC)

Indeterminate Colitis

Study ID

NCT07195123

Start date

Oct 23, 2025

Status verified date

Oct, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

SMART-IBD

Daily medication and diary completion reminders are provided to participants. Additional psychoeducational content regarding self-management skills will be provided in-app.

Primary outcome measure

  • Medication adherence [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Kevin Hommel, PhD

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

Jessica King, BA

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

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Kevin Hommel, PhD

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

Jessica King, BA

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

Principal Investigator:

Kevin Hommel, PhD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Nov 21, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-11-21.