Evaluation of the SMART IBD App in Pediatric IBD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SMART-IBD.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Disease (IBD), IBD (Inflammatory Bowel Disease), IBD - Inflammatory Bowel Disease, Ulcerative Colitis (UC). Basic parameters: 13 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease
Overview
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 35 youth (ages 13-17) with IBD using an app that contains daily symptom diaries, education content, medication reminders, as well as monthly engagement challenges to 35 youth in an attention control group that will complete daily diaries. The length of the intervention will include one month of baseline symptom and adherence collection, a baseline assessment, 5 months of intervention, and a post-treatment assessment.
Interventions
- Behavioral SMART-IBD
Daily medication and diary completion reminders are provided to participants. Additional psychoeducational content regarding self-management skills will be provided in-app.
Primary outcome measures
- Medication adherence [Time frame: 6 months]
Secondary outcome measures (3)
- Disease Activity [Time frame: 6 months]
- Sleep Duration [Time frame: 6 months]
- Stress [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of IBD (Crohn's Disease, ulcerative colitis, or indeterminate colitis)
- Prescribed at least one daily or weekly medication for treatment of IBD
- <86% adherence to prescribed medication
- Access to internet via Wi-Fi or data plan and access to smartphone
- English fluency for patient and caregiver
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT07195123 · SMART-IBD R21 RCT