SMART-IBD App Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammatory Bowel Diseases, IBD, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Behavioral: SMART-IBD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMART-IBD<br>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<br>* Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.<br>|
| No Intervention: Attention Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD