Inflammatory Bowel DiseasesNCT06023667
SMART-IBD App Trial
A study testing SMART-IBD in people with Inflammatory Bowel Diseases and IBD, 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 a sample of 20 youth (ages 13-17) with IBD using an app that has… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Inflammatory Bowel Diseases, IBD, Crohn 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
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2022to 28 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
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.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Self-Management Assistance for Recommended Treatement (SMART) App Randomized Control Trial
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.
- Conditions
- Inflammatory Bowel Diseases, IBD, Crohn Disease, Ulcerative Colitis
- Being tested
- SMART-IBD
- Keywords
- IBD
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
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 educational content regarding self-management skills will be provided.
| Study group | Role | What they receive |
|---|---|---|
| SMART-IBD | Experimental | The SMART-IBD app consists of educational content, medication reminders, and weekly app engagement challenges. App users will participate in weekly challenges that focus on topics such as adherence, sleep, and diary usage. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention, and one month of diaries post-intervention. 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, one month of diaries during intervention and one month of diaries post-intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start14 Dec 2022
- Primary completion28 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- 45 participants (actual)
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
- NCT06023667
- Sponsor's protocol ID
- SMART-IBD
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dattilo TM, Robbertz AS, Denson LA, Hommel KA. A pilot randomized controlled trial of the self-management assistance for recommended treatment inflammatory bowel disease app for adolescents with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2026 Jun 1. doi: 10.1002/jpn3.70473. Online ahead of print.
PubMed 42220282Hommel KA, Noser AE, Plevinsky J, Gamwell K, Denson LA. Pilot and feasibility of the SMART IBD mobile app to improve self-management in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2024 Jun;78(6):1273-1278. doi: 10.1002/jpn3.12229. Epub 2024 Apr 29.
PubMed 38682397
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management Assistance for Recommended Treatement (SMART) App Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06023667
- Acronym / sponsor ID
- SMART-IBD
- Conditions
- Inflammatory Bowel Diseases, IBD, Crohn Disease, Ulcerative Colitis
- Keywords
- IBD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 5 Sep 2023 (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 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.
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 | Experimental | Behavioral: SMART-IBDThe SMART-IBD app consists of educational content, medication reminders, and weekly app engagement challenges. App users will participate in weekly challenges that focus on topics such as adherence, sleep, and diary usage. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention, and one month of diaries post-intervention. |
| 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, one month of diaries during intervention and one month of diaries post-intervention. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
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 educational content regarding self-management skills will be provided. | Behavioural | SMART-IBD |
Primary outcome
Medication adherence
Time frame: 3 months
Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Derived from this study: PubMed 42220282Dattilo TM, Robbertz AS, Denson LA, Hommel KA. A pilot randomized controlled trial of the self-management assistance for recommended treatment inflammatory bowel disease app for adolescents with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2026 Jun 1. doi: 10.1002/jpn3.70473. Online ahead of print.
- Derived from this study: PubMed 38682397Hommel KA, Noser AE, Plevinsky J, Gamwell K, Denson LA. Pilot and feasibility of the SMART IBD mobile app to improve self-management in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2024 Jun;78(6):1273-1278. doi: 10.1002/jpn3.12229. Epub 2024 Apr 29.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Diseases and IBD, 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 4 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: finished, as of the sponsor's last update on 28 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023667, which also lists 2 linked publications.
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 28 Aug 2025.