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Behavioral Intervention
SMART-IBD App for Inflammatory Bowel Disease
N/A
Waitlist Available
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial tests if an app helps teens with IBD take their medicine and learn self-care skills. It will compare 15 teens using the app to 15 teens in a control group.
Who is the study for?
This trial is for adolescents aged 13-17 with Crohn's disease, ulcerative colitis, or indeterminate colitis. Participants must have internet access and a smartphone, be fluent in English, and be on at least one IBD medication. Those with developmental disorders or serious mental illness are excluded.Check my eligibility
What is being tested?
The SMART-IBD app is being tested to see if it helps young people manage their IBD better by reminding them to take their meds and teaching them about their condition. The study compares an app-using group against a control group over three months.See study design
What are the potential side effects?
Since this trial involves the use of an educational smartphone app rather than medication, there are no direct medical side effects expected from participating in this study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Medication adherence
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SMART-IBDExperimental Treatment1 Intervention
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.
Group II: Attention ControlActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SMART-IBD
2022
N/A
~50
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,530,625 Total Patients Enrolled
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