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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART-IBD | Experimental | 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. |
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| Attention Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMART-IBD | Behavioral | Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42220282 | Derived | Dattilo TM, Robbertz AS, Denson LA, Hommel KA. A pilot randomized controlled trial of the self-management assistance for recommended treatment inflammatory bowel disease app for adolescents with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2026 Jun 1. doi: 10.1002/jpn3.70473. Online ahead of print. | |
| 38682397 | Derived |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments will be blinded. Only study coordinators will have access to the assignment of each participant.
| Hommel KA, Noser AE, Plevinsky J, Gamwell K, Denson LA. Pilot and feasibility of the SMART IBD mobile app to improve self-management in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2024 Jun;78(6):1273-1278. doi: 10.1002/jpn3.12229. Epub 2024 Apr 29. |
| D003092 | Colitis |
| D003108 | Colonic Diseases |