70 Participants Needed

SMART-IBD App for IBD

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JK
Overseen ByJessica King, BA
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Medical Center, Cincinnati
Must be taking: IBD medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called SMART-IBD to determine if it helps teenagers with inflammatory bowel disease (IBD) adhere to their medication and manage their condition more effectively. The app features daily symptom tracking, educational content, medication reminders, and monthly challenges to enhance engagement. Teenagers aged 13-17 with IBD who frequently miss medication doses, have access to a smartphone and the internet, and speak English may be suitable candidates for this trial. Participants will either use the app or track their symptoms daily for about six months to assess the app's impact. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could improve daily IBD management.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, since the study focuses on improving medication adherence, it is likely that you will continue taking your prescribed IBD medications.

What prior data suggests that the SMART-IBD App is safe for adolescents with IBD?

In a previous study, patients found the SMART-IBD app helpful and used it frequently, indicating comfort with the app. No negative effects were reported, suggesting its safety for teenagers with inflammatory bowel disease (IBD) in managing symptoms and medication. The app tracks symptoms, provides education, and sends reminders, all of which are generally safe activities.12345

Why are researchers excited about this trial?

Researchers are excited about the SMART-IBD App because it offers a fresh approach for managing Inflammatory Bowel Disease (IBD) by focusing on patient engagement and education. Unlike traditional treatments that often rely on medication alone, this app combines educational content, medication reminders, and interactive monthly challenges to support adherence and lifestyle management. This innovative method encourages active participation and self-monitoring through daily symptom diaries and monthly engagement tasks, which could empower patients to manage their condition more effectively.

What evidence suggests that the SMART-IBD app is effective for improving medication adherence and self-management in adolescents with IBD?

Research shows that smartphone apps like SMART-IBD can assist young people with inflammatory bowel disease (IBD) in taking their medication and managing their condition more effectively. Studies have found that patients consider the app easy to use and helpful. In this trial, participants in the SMART-IBD App arm will use the app, which includes features like daily symptom diaries and medication reminders, crucial for effective IBD management. Regular app usage by some patients suggests it might aid in maintaining their treatment regimen. Overall, early feedback from users is positive, indicating the app could benefit teenagers with IBD.12367

Are You a Good Fit for This Trial?

This trial is for adolescents aged 13-17 with Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. Participants should be willing to use a smartphone app daily for symptom tracking, medication reminders, and education.

Inclusion Criteria

Less than 86% adherence to prescribed medication
Access to internet via Wi-Fi or data plan and access to smartphone
English fluency for patient and caregiver
See 2 more

Exclusion Criteria

Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
I or my caregiver have a serious mental illness diagnosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

One month of baseline symptom and adherence collection, including a baseline assessment

4 weeks
1 visit (in-person or virtual)

Intervention

Participants use the SMART-IBD app for 5 months, including daily symptom diaries, educational content, medication reminders, and monthly engagement challenges

5 months

Post-treatment assessment

Post-treatment assessment to evaluate outcomes such as medication adherence and disease activity

1-2 weeks
1 visit (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SMART-IBD App
Trial Overview The SMART-IBD app is being tested to see if it can help young people with IBD take their medications correctly and manage their condition better. The study will compare two groups: one using the app with extra features against another group just keeping a diary.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: SMART-IBD AppExperimental Treatment1 Intervention
Group II: Attention ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Citations

Evaluation of the SMART IBD App in Pediatric IBDStudy Overview. The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in improving medication adherence and ...
Design and methodology - PMC - PubMed Central - NIHFindings indicating that the SMART IBD app improves outcomes will benefit patients who have difficulties with self-management by providing ...
User-needs based app for patients with inflammatory bowel ...Many existing mobile applications for inflammatory bowel disease (IBD) lack core features such as patient-reported outcomes (PROs), personalized ...
Pilot and feasibility of the SMART IBD mobile app to ...Results indicated that patients rated the app quality as good and accessed the app adequately overall, with some pages being used often.
Pilot and feasibility of the SMART IBD mobile app to ...Abstract. Objectives: Access to evidence‐based self‐management support in pediatric inflammatory bowel disease (IBD) is a significant challenge.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38682397/
Pilot and feasibility of the SMART IBD mobile app to ...Results: Results indicated that patients rated the app quality as good and accessed the app adequately overall, with some pages being used often. Medication ...
Mobile Phone Apps for Inflammatory Bowel Disease Self- ...The aim of this study was to explore the content and tools of existing IBD apps to identify functionalities that may facilitate patient self-management. Methods.
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