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

Children's Hospital Medical Center, Cincinnati1 site in 1 country45 target enrollmentDecember 14, 2022

ConditionsInflammatory Bowel Diseases IBD Crohn Disease Ulcerative Colitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inflammatory Bowel Diseases
Sponsor: Children's Hospital Medical Center, Cincinnati
Enrollment: 45
Locations: 1
Primary Endpoint: Medication adherence
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

December 14, 2022

End Date

December 28, 2023

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Children's Hospital Medical Center, Cincinnati

Responsible Party

Sponsor

Eligibility Criteria

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