SMART-IBD App Trial

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 a sample of 20 youth (ages 13-17) with IBD using an app that has educational content and medication reminders to 20 youth in an attention control group. The length of the intervention will include one month of baseline adherence data collection, one month of intervention, and one month of post-treatment adherence data collection.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases IBD Intestinal Diseases Ulcerative Colitis

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively IBD)
Prescribed at least one medication used to treat IBD, regardless of route of administration
Access to internet or wi-fi or data plan and access to smartphone
English fluency for patient and clinician

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 educational content regarding self-management skills will be provided.

Primary outcomes

Medication adherence

Time frame: 3 months

Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Self-Management Assistance for Recommended Treatement (SMART) App Randomized Control Trial

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Sep 5, 2023
Registry last updated: Aug 28, 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.

Published trials that share one or more normalized conditions with this study.

Completed