SMART-IBD App Trial

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Ulcerative Colitis; IBD; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Behavioral: SMART-IBD

Study type: Interventional

Funder types: Other

Identifiers

NCT06023667

SMART-IBD

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 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.

Enrollment: 45 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

SMART-IBD

Experimental group

Description:

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.

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