SMART-IBD App Trial

NCT06023667 | Completed

• 1 other identifier: SMART-IBD
• Study Type: interventional
• Target: 45
• 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 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.

Conditions

Inflammatory Bowel Diseases; IBD; Crohn Disease; Ulcerative Colitis

Keywords

IBD

Outcome Measures

Primary Outcomes (1)

• Medication adherence

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

  3 months

Study Arms (2)

SMART-IBD

EXPERIMENTAL

The SMART-IBD app consists of educational content, medication reminders, and weekly app engagement challenges. App users will participate in weekly challenges that focus on topics such as adherence, sleep, and diary usage. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention, and one month of diaries post-intervention.

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, one month of diaries during intervention and one month of diaries post-intervention.

Interventions

SMART-IBD BEHAVIORAL

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

SMART-IBD

Eligibility Criteria

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

You may qualify if:

• 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

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

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

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 assessments 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: July 28, 2023
• First Posted: September 5, 2023
• Study Start: December 14, 2022
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (1)