Crohn Disease, IBD, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
IBD
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 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.
Interventions
BEHAVIORALSMART-IBD
Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively IBD) * Prescribed at least one medication used to treat IBD, regardless of route of administration * Access to internet or wi-fi or data plan and access to smartphone * English fluency for patient and clinician
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence | 3 months | Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app |
Countries
United States
Outcome results
None listed