Evaluation of the SMART IBD App in Pediatric IBD

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: IBD (Inflammatory Bowel Disease); Inflammatory Bowel Disease (IBD); IBD; Ulcerative Colitis (UC); Crohn Disease (CD); Indeterminate Colitis; IBD - Inflammatory Bowel Disease

Treatments: Behavioral: SMART-IBD

Study type: Interventional

Funder types: Other

Identifiers

NCT07195123

SMART-IBD R21 RCT

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

SMART-IBD App

Experimental group

Description:

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.

Treatment:

Behavioral: SMART-IBD

Attention Control

No Intervention group

Description:

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.