- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06023667
SMART-IBD App Trial
January 29, 2024 updated by: Children's Hospital Medical Center, Cincinnati
Self-Management Assistance for Recommended Treatement (SMART) App Randomized Control Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kevin Hommel, PhD
- Phone Number: 513-803-0407
- Email: kevin.hommel@cchmc.org
Study Contact Backup
- Name: Jessica King, BA
- Phone Number: 513-803-0920
- Email: jessica.king1@cchmc.org
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SMART-IBD
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.
|
Daily medication and diary completion reminders are provided to participants.
Additional educational content regarding self-management skills will be provided.
|
No Intervention: Attention Control
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication adherence
Time Frame: 3 months
|
Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2022
Primary Completion (Actual)
December 28, 2023
Study Completion (Actual)
December 28, 2023
Study Registration Dates
First Submitted
July 28, 2023
First Submitted That Met QC Criteria
September 1, 2023
First Posted (Actual)
September 5, 2023
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMART-IBD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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