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NCT06023667 Clinical Trial

SMART-IBD App Trial

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06023667
Other study ID # SMART-IBD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 14, 2022
Est. completion date December 28, 2023

Study information
Verified date January 2024
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date December 28, 2023
Est. primary completion date December 28, 2023
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• SMART-IBD
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Medication adherence Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app 3 months
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