SMART-IBD App Trial

Not Applicable

Completed

• Conditions: Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases; IBD
• Interventions: Behavioral: SMART-IBD

• Registration Number: NCT06023667
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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 15 youth (ages 13-17) with IBD using an app that has educational content and medication reminders to 15 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-14
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-05
• Primary Completion: 2023-12-28
• Study Completion: 2023-12-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMART-IBD	SMART-IBD	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.

Primary Outcome Measures

Name	Time	Method
Medication adherence	3 months	Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States