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NCT Number: NCT07195123

Evaluation of the SMART IBD App in Pediatric IBD

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.

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Key information

Conditions

Inflammatory Bowel Disease (IBD) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn Disease (CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases IBD IBD (Inflammatory Bowel Disease) IBD - Inflammatory Bowel Disease Indeterminate Colitis Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis (UC)

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Medication adherence

    Time frame: 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 outcomes

  1. Disease Activity

    Time frame: 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.

  2. Sleep Duration

    Time frame: 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.

  3. Stress

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica King, BA

CONTACT

[email protected]

513-803-0920

Kevin Hommel, PhD

CONTACT

[email protected]

513-803-0407

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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