Inflammatory Bowel Disease (IBD)NCT07195123
Evaluation of the SMART IBD App in Pediatric IBD
A study testing SMART-IBD in people with Inflammatory Bowel Disease (IBD) and IBD (Inflammatory Bowel Disease), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), IBD (Inflammatory Bowel Disease), IBD - Inflammatory Bowel Disease
- What is being tested?
- SMART-IBD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Kevin Hommel, PhD, 513-803-0407, kevin.hommel@cchmc.org
Jessica King, BA, 513-803-0920, jessica.king1@cchmc.org
About this study
Official title: Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease
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.
- Conditions
- Inflammatory Bowel Disease (IBD), IBD (Inflammatory Bowel Disease), IBD - Inflammatory Bowel Disease, Ulcerative Colitis (UC), Indeterminate Colitis, Crohn Disease (CD)
- Being tested
- SMART-IBD
- Keywords
- IBD, Inflammatory Bowel Disease, Ulcerative Colitis, Indeterminate Colitis, Crohns Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART-IBDBehavioural
Daily medication and diary completion reminders are provided to participants. Additional psychoeducational content regarding self-management skills will be provided in-app.
| Study group | Role | What they receive |
|---|---|---|
| SMART-IBD App | Experimental | 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. Receives: Behavioral: SMART-IBD |
| Attention Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
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.
Measured: 6 months
Secondary outcomes (3)
Disease Activity
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.
Measured: 6 months
Sleep Duration
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.
Measured: 6 months
Stress
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start23 Oct 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195123
- Sponsor's protocol ID
- SMART-IBD R21 RCT
- Status last verified
- Oct 2025
- First submitted
- 17 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07195123
- Acronym / sponsor ID
- SMART-IBD R21 RCT
- Conditions
- Inflammatory Bowel Disease (IBD), IBD (Inflammatory Bowel Disease), IBD - Inflammatory Bowel Disease, Ulcerative Colitis (UC), Indeterminate Colitis, Crohn Disease (CD)
- Keywords
- IBD, Inflammatory Bowel Disease, Ulcerative Colitis, Indeterminate Colitis, Crohns Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART-IBD App | Experimental | Behavioral: SMART-IBDThe 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. |
| Attention Control | No intervention | –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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART-IBDDaily medication and diary completion reminders are provided to participants. Additional psychoeducational content regarding self-management skills will be provided in-app. | Behavioural | SMART-IBD App |
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.
3 secondary outcomes
Disease Activity
Time frame: 6 months
Sleep Duration
Time frame: 6 months
Stress
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART-IBD in people with Inflammatory Bowel Disease (IBD) and IBD (Inflammatory Bowel Disease), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Hommel, PhD (513-803-0407, kevin.hommel@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.