Expired Study
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Charlottesville, Virginia 22901


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - Diagnosis of pervasive developmental disorder in patient or caregiver - Diagnosis of serious mental illness (example, schizophrenia) in patient or caregiver


NCT ID:

NCT01966744


Primary Contact:

Study Chair
Lee Denson, M.D.
Children's Hospital Medical Center, Cincinnati


Backup Contact:

N/A


Location Contact:

Charlottesville, Virginia 22901
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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