Crohn Disease (CD) · IBD · IBD - Inflammatory Bowel Disease · IBD (Inflammatory Bowel Disease) · Indeterminate Colitis · Inflammatory Bowel Disease (IBD) · Ulcerative Colitis (UC)
SMART-IBD App Study for Adolescents With Inflammatory Bowel Disease
This randomized study compares the SMART-IBD app with a daily-diary attention control among 70 adolescents with inflammatory bowel disease to examine medication adherence, self-management, disease activity, sleep, and stress.
Registry title: Evaluation of the SMART IBD App in Pediatric IBD
1 recruiting U.S. site ↓Study at a glance
- Age
- 13 Years–17 Years
- Treatment
- SMART-IBD
- Design
- Randomized · Double
- Central study contact
- Kevin Hommel, PhD513-803-0407kevin.hommel@cchmc.org
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Research question
Does using the SMART-IBD smartphone app improve medication adherence and self-management skills in adolescents with inflammatory bowel disease compared with completing daily diaries without the app's intervention content?
Participant snapshot
Who the study is looking for
- The study is looking for adolescents ages 13 through 17.
- Participants must have confirmed Crohn disease, ulcerative colitis, or indeterminate colitis.
- Participants must be prescribed at least one daily or weekly medication for inflammatory bowel disease and have less than 86% adherence to prescribed medication.
- Participants need smartphone and internet access, and both the patient and caregiver must be fluent in English.
- The registry lists one recruiting location at Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio.
Participation overview
What participation may involve
Both groups complete a one-month run-in period with diaries, a baseline assessment, five months of daily symptom diaries, and a post-treatment assessment. The SMART-IBD group also receives app reminders, educational content, and monthly engagement challenges. What participation may involve: - Complete daily symptom diaries during the run-in and intervention periods. - Complete baseline and post-treatment assessments. - Report whether each medication dose was taken so medication adherence can be assessed. - Provide stool samples at baseline and after the intervention for disease-activity assessment. - Report sleep duration and stress through the app diary. - If assigned to SMART-IBD, receive medication and diary reminders, review educational content, and participate in five monthly app challenges. The reported participation period includes one month of baseline symptom and adherence collection followed by five months of intervention and a post-treatment assessment.
Study interventions
What participants may receive or do
- SMART-IBD: Participants assigned to SMART-IBD use a smartphone app with daily medication and diary reminders, self-management education, and five monthly engagement challenges on topics such as adherence, sleep, and diary use.
Study design
How the comparison works
This is a randomized, parallel-group study comparing 35 adolescents assigned to SMART-IBD with 35 assigned to an attention-control group that completes daily diaries without intervention content. Participants are assigned at random to one of two groups: SMART-IBD or attention control. The registry describes double masking: the principal investigator, statistician, co-investigators, and personnel involved in endpoint analyses are blinded, while study coordinators can access assignments. It does not state that participants are masked. The attention-control group receives no intervention content but completes one month of run-in diaries, a baseline assessment, five months of daily symptom diaries, and a post-treatment assessment. No placebo or sham intervention is described; the comparison group completes diaries without receiving intervention content.
Reported activities
Procedures and tests
- Daily symptom diaries are completed during the run-in and five-month intervention periods.
- Medication adherence is measured from daily responses about whether each dose of each medication was taken.
- Baseline and post-treatment assessments are reported for both groups.
- Stool samples are collected at baseline and after the intervention to assess disease activity.
- Disease-activity information includes fecal calprotectin and stool frequency, plus rectal bleeding for ulcerative colitis or abdominal pain for Crohn disease.
- Participants in both groups report sleep duration through the app diary.
- Participants in both groups rate stress through the app diary on a scale from 0 to 10.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- A confirmed diagnosis of Crohn disease, ulcerative colitis, or indeterminate colitis is required.
- Participants must be 13 through 17 years old.
- Participants must be prescribed at least one daily or weekly medication for inflammatory bowel disease.
- Documented adherence to prescribed medication must be below 86%.
- Participants must have internet access through Wi-Fi or a data plan and access to a smartphone.
- Both the patient and caregiver must be fluent in English.
Possible reasons someone may not be able to join
- The patient or caregiver is excluded if medical chart review identifies a pervasive developmental disorder.
- The patient or caregiver is excluded if medical chart review identifies a serious mental illness, such as schizophrenia.
Important unknowns
What the record does not make clear
- The record describes baseline and post-treatment assessments but does not report the number, timing, location, or format of study visits.
- Participants must be prescribed inflammatory bowel disease medication, but the record does not explain whether usual medications must remain unchanged during the study.
- The record does not state whether any medications must be stopped or paused before enrollment.
- Stool samples and disease-activity assessments are described, but the record does not state whether endoscopy or other procedures are required.
- The record does not explain which study-related or clinical-care costs are covered or billed to insurance.
- The record does not state whether participants receive payment or reimbursement.
- The record does not describe parking, mileage, lodging, or other travel assistance.
- The intervention uses a smartphone app, but the record does not state whether all participation can occur remotely.
- The record does not state whether participants can continue using SMART-IBD after the study.
Before contacting the site
Questions for the study team
- How many study visits are required, and which can be completed remotely?
- How will the study determine whether medication adherence is below 86% during screening?
- Can current inflammatory bowel disease medications be continued or changed during the study?
- What happens during the baseline and post-treatment assessments?
- Besides the reported stool samples, are blood tests, imaging, endoscopy, or other procedures required?
- Which study-related costs are covered, and are compensation or travel reimbursements available?
- Will families be told which group the participant joined, and can attention-control participants use SMART-IBD after the study?
Before changing care
Questions for your gastroenterologist
- Would joining this study require any change to the current inflammatory bowel disease treatment plan?
- Is the patient's disease stable enough for participation, and how should changes in symptoms or disease activity be handled?
- What approved adherence-support or self-management options are available outside this study?
- How should the gastroenterology team and research team coordinate medication changes, stool testing, and follow-up care?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Children's Hospital Medical Center, Cincinnati
- Organization class
- Other
- Organization study ID
- SMART-IBD R21 RCT
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Investigator, Outcomes Assessor
- Standard age groups
- Child
Study arms
Experimental
SMART-IBD App
The SMART-IBD app consists of educational content, medication reminders, and monthly app engagement challenges. App users will participate in 5 monthly challenges that focus on topics such as adherence, sleep, and diary usage. Participants in this arm will complete one month of run-in diaries, a baseline assessment, 5 months of intervention, including daily symptom diaries, and a post-treatment assessment.
Interventions: Behavioral: SMART-IBD
No Intervention
Attention Control
Participants in this arm will not receive any intervention content. Participants in this arm will complete one month of run-in diaries, a baseline assessment, 5 months of daily symptom diaries, 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.
Eligibility
13 Years–17 Years
All
Not accepted
Inclusion criteria (5)
- Confirmed diagnosis of IBD (Crohn's Disease, ulcerative colitis, or indeterminate colitis)Registry-derived · unreviewed
- Prescribed at least one daily or weekly medication for treatment of IBDRegistry-derived · unreviewed
- \<86% adherence to prescribed medicationRegistry-derived · unreviewed
- Access to internet via Wi-Fi or data plan and access to smartphoneRegistry-derived · unreviewed
- English fluency for patient and caregiverRegistry-derived · unreviewed
Exclusion criteria (2)
- Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart reviewRegistry-derived · unreviewed
- Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart reviewRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Medication adherence
Time frame: 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 outcome
Disease Activity
Time frame: 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.
Secondary outcome
Sleep Duration
Time frame: 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.
Secondary outcome
Stress
Time frame: 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.
Recruiting locations in the United States
Cincinnati Children's Hospital Medical Center
RecruitingCincinnati, Ohio, 45229, United States
Kevin Hommel, PhD513-803-0407kevin.hommel@cchmc.org
Jessica King, BA513-803-0920jessica.king1@cchmc.org
Kevin Hommel, PhD
Central study contacts
Registry dates
- First posted
- Sep 26, 2025
- Primary completion
- Feb 28, 2027
- Overall completion
- Aug 31, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.