SMART-IBD App Trial
Study Details
Study Description
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 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
Behavioral: SMART-IBD
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
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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. |
Outcome Measures
Primary Outcome Measures
- Medication adherence [3 months]
Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively IBD)
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Prescribed at least one medication used to treat IBD, regardless of route of administration
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Access to internet or wi-fi or data plan and access to smartphone
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English fluency for patient and clinician
Exclusion Criteria:
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Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
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Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
Sponsors and Collaborators
- Children's Hospital Medical Center, Cincinnati
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMART-IBD