Crohn Disease (CD), IBD, IBD - Inflammatory Bowel Disease, IBD (Inflammatory Bowel Disease), Indeterminate Colitis, Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
Conditions
Keywords
IBD, Inflammatory Bowel Disease, Ulcerative Colitis, Indeterminate Colitis, Crohns Disease
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 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
BEHAVIORALSMART-IBD
Daily medication and diary completion reminders are provided to participants. Additional psychoeducational content regarding self-management skills will be provided in-app.
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 analyses 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence | 6 months | Medication adherence will be measured by daily responses by participants to prompts in the SMART IBD app regarding whether each dose was taken for each medication. A mean adherence score will be calculated across medications for each participant for the 28 day periods at baseline and post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity | 6 months | PROs will be collected regarding composite disease activity comprised of fecal calprotectin, stool frequency, and rectal bleeding for ulcerative colitis and fecal calprotectin, stool frequency, and abdominal pain for Crohn's. Stool samples collected at baseline and post-assessment will also be utilized to assess diseases activity. |
| Sleep Duration | 6 months | Sleep duration will be assessed via the SMART IBD App diary on a scale of 0-18 hours or more with half hour increments. Participants in both arms will report sleep duration via the diary. |
| Stress | 6 months | Stress will be assessed via the SMART IBD App diary on a scale of 0-10, where 0 is no stress and 10 is highest stress. Participants in both arms will report stress via the diary. |
Countries
United States
Contacts
Primary ContactKevin Hommel, PhD
Backup ContactJessica King, BA
Outcome results
None listed