Evaluation of the SMART IBD App in Pediatric IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-23

Study Completion Date

2027-08-31

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 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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The study PI, statistician, co-investigators, and all personnel who are involved in endpoint analyses will be blinded. Only study coordinators will have access to the assignment of each participant.

Study Groups

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SMART-IBD App

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.

Group Type EXPERIMENTAL

SMART-IBD

Intervention Type BEHAVIORAL

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

Attention Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SMART-IBD

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No