Crohn's DiseaseSMARTNCT01966744
Self-Management Assistance for Recommended Treatment (SMART) Portal
An observational study of Crohn's Disease and Ulcerative Colitis, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
The purpose of the study is to develop, evaluate, and optimize an interactive website (the SMART portal). The SMART portal will use IBD-specific and general assessments and interventions to reduce the burden of common barriers to treatment adherence and enhance self-management skills. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis
- How many people
- 87 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Jun 2016
- Phase
- Observational
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients, caregivers, clinicians, and nurses will be recruited from the IBD clinic at Cincinnati Children's Hospital Medical Center.
Who may be able to join
- Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively known as IBD)
- Patient between 11 and 18 years of age
- Patient prescribed at least one oral medication used to treat IBD
- Access to the internet whether public (example, library) or private (example, home, personal)
- English fluency for patient, caregiver, and clinician/nurse
- Clinician/nurse currently providing medical treatment to patients diagnosed with IBD through the IBD Center at Cincinnati Children's Hospital Medical Center
Who cannot join
- Diagnosis of pervasive developmental disorder in patient or caregiver
- Diagnosis of serious mental illness (example, schizophrenia) in patient or caregiver
Trial locations and contacts
2 sites in 1 country.
United States2 sites
BeHealth Solutions, LLC
Charlottesville, Virginia, 22901
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The purpose of the study is to develop, evaluate, and optimize an interactive website (the SMART portal). The SMART portal will use IBD-specific and general assessments and interventions to reduce the burden of common barriers to treatment adherence and enhance self-management skills. This study aims to build and revise the SMART portal according to feedback and testing from participants.
Read the detailed description
The study consists of three phases for development and evaluation of the SMART portal. Phase 1 is the development of online assessments and intervention components. There will be no participant interaction with the portal during Phase 1. Phase 2 will consist of one, individual interview with patients, caregivers, and clinicians/nurses to interact with a portal prototype and provide feedback. Phase 3 will contain an open trial for patients and caregivers with baseline, 2-6 months interacting with the portal and progressing through applicable intervention components, and post-treatment. Patient test data will also be loaded into the portal during Phase 3 for clinicians/nurses to interact with for 2-6 months. Feedback from all users will be collected at post-treatment for optimization of the portal.
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinicians/Nurses | Clinicians and nurses who treat patients diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization. | |
| Patients | Patients age 11-18 years diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization. | |
| Caregivers | Caregivers of patients diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization. |
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 pill count data provided by patients or caregivers at baseline and post-treatment during Phase 3. Phase 3 will start approximately in October 2014 and continue through March 2015.
Measured: Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Secondary outcomes (2)
Disease severity
Disease severity will be measured at baseline, post-treatment, and periodically throughout the intervention as the patient logs in to view intervention materials during Phase 3. The portal will prompt the patient to complete disease severity questions throughout the intervention, but it will be dependent upon the patient actually logging into the system. Therefore, exact time points during treatment are unknown. The Pediatric Ulcerative Colitis Activity Index (PUCAI) will be used to measure disease severity for patients diagnosed with ulcerative colitis and indeterminate colitis, and the Partial Harvey Bradshaw (PHBI) will be used for patients diagnosed with Crohn's disease. Phase 3 will start approximately in October 2014 and continue through March 2015.
Measured: Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Health-related quality of life
The IMPACT-III will be used during baseline and post-treatment in Phase 3 to measure quality of life in patients. Phase 3 will start approximately in October 2014 and continue through March 2015.
Measured: Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lee Denson, M.D., Study chair, Children's Hospital Medical Center, CincinnatiJames Peugh, Ph.D., Study chair, Children's Hospital Medical Center, CincinnatiKorey Hood, Ph.D., Study chair, University of California, San FranciscoLee Ritterband, Ph.D., Study chair, BeHealth Solutions, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966744
- Sponsor's protocol ID
- SMART
- Acronym
- SMART
- Status last verified
- Jul 2017
- First submitted
- 4 Oct 2013
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hommel KA, Ramsey RR, Gray WN, Denson LA. Digital Therapeutic Self-Management Intervention in Adolescents With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2023 Jan 1;76(1):38-42. doi: 10.1097/MPG.0000000000003623. Epub 2022 Sep 20.
PubMed 36123761
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management Assistance for Recommended Treatment (SMART) Portal
- ClinicalTrials.gov ID
- NCT01966744
- Acronym / sponsor ID
- SMART / SMART
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Oct 2013 (estimated)
- 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 purpose of the study is to develop, evaluate, and optimize an interactive website (the SMART portal). The SMART portal will use IBD-specific and general assessments and interventions to reduce the burden of common barriers to treatment adherence and enhance self-management skills. This study aims to build and revise the SMART portal according to feedback and testing from participants.
Detailed description
The study consists of three phases for development and evaluation of the SMART portal. Phase 1 is the development of online assessments and intervention components. There will be no participant interaction with the portal during Phase 1. Phase 2 will consist of one, individual interview with patients, caregivers, and clinicians/nurses to interact with a portal prototype and provide feedback. Phase 3 will contain an open trial for patients and caregivers with baseline, 2-6 months interacting with the portal and progressing through applicable intervention components, and post-treatment. Patient test data will also be loaded into the portal during Phase 3 for clinicians/nurses to interact with for 2-6 months. Feedback from all users will be collected at post-treatment for optimization of the portal.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinicians/Nurses | – | –Clinicians and nurses who treat patients diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization. |
| Patients | – | –Patients age 11-18 years diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization. |
| Caregivers | – | –Caregivers of patients diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients, caregivers, clinicians, and nurses will be recruited from the IBD clinic at Cincinnati Children's Hospital Medical Center.
Key inclusion criteria (6 listed)
- Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively known as IBD)
- Patient between 11 and 18 years of age
- Patient prescribed at least one oral medication used to treat IBD
- Access to the internet whether public (example, library) or private (example, home, personal)
- English fluency for patient, caregiver, and clinician/nurse
Key exclusion criteria (2 listed)
- Diagnosis of pervasive developmental disorder in patient or caregiver
- Diagnosis of serious mental illness (example, schizophrenia) in patient or caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication adherence
Time frame: Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Medication adherence will be measured by pill count data provided by patients or caregivers at baseline and post-treatment during Phase 3. Phase 3 will start approximately in October 2014 and continue through March 2015.
2 secondary outcomes
Disease severity
Time frame: Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Health-related quality of life
Time frame: Phase 3 - Approximately 2-6 months, depending upon progression through portal components
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 19 Jul 2017.
- Derived from this study: PubMed 36123761Hommel KA, Ramsey RR, Gray WN, Denson LA. Digital Therapeutic Self-Management Intervention in Adolescents With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2023 Jan 1;76(1):38-42. doi: 10.1097/MPG.0000000000003623. Epub 2022 Sep 20.
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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.
Lee Denson, M.D. study chair
Children's Hospital Medical Center, Cincinnati
James Peugh, Ph.D. study chair
Children's Hospital Medical Center, Cincinnati
Korey Hood, Ph.D. study chair
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Children's Hospital Medical Center, Cincinnati at 2 sites 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 6 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 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Phase 3 - Approximately 2-6 months, depending upon progression through portal components). 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 NCT01966744, which also lists 1 linked publication.
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 19 Jul 2017.