Self-Management Assistance for Recommended Treatment (SMART) Portal
SMART
1 other identifier
observational
87
1 country
2
Brief 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. This study aims to build and revise the SMART portal according to feedback and testing from participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2013
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 4, 2013
CompletedFirst Posted
Study publicly available on registry
October 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 19, 2017
July 1, 2017
2.9 years
October 4, 2013
July 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Secondary Outcomes (2)
Disease severity
Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Health-related quality of life
Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Study Arms (3)
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.
Eligibility Criteria
Patients, caregivers, clinicians, and nurses will be recruited from the IBD clinic at Cincinnati Children's Hospital Medical Center.
You may qualify if:
- 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
You may not qualify if:
- Diagnosis of pervasive developmental disorder in patient or caregiver
- Diagnosis of serious mental illness (example, schizophrenia) in patient or caregiver
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
BeHealth Solutions, LLC
Charlottesville, Virginia, 22901, United States
Related Publications (1)
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.
PMID: 36123761DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lee Denson, M.D.
Children's Hospital Medical Center, Cincinnati
- STUDY CHAIR
James Peugh, Ph.D.
Children's Hospital Medical Center, Cincinnati
- STUDY CHAIR
Korey Hood, Ph.D.
University of California, San Francisco
- STUDY CHAIR
Lee Ritterband, Ph.D.
BeHealth Solutions, LLC.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2013
First Posted
October 22, 2013
Study Start
July 1, 2013
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 19, 2017
Record last verified: 2017-07