Clinical trial NCT01966744: Self-Management Assistance for Recommended Treatment (SMART) Portal
Official title: Self-Management Assistance for Recommended Treatment (SMART) Portal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Inflammatory Bowel Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-10-22
Enrollment: 87
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, caregivers, clinicians, and nurses will be recruited from the IBD clinic at Cincinnati Children's Hospital Medical Center.

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.

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.

Eligibility 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

Primary outcomes:
measure: Medication adherence
timeFrame: Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Secondary outcomes:
measure: Disease severity
timeFrame: Phase 3 - Approximately 2-6 months, depending upon progression through portal components
measure: Health-related quality of life
timeFrame: Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Charlottesville
country: United States
facility: BeHealth Solutions, LLC
state: Virginia
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lee Denson, M.D.
role: STUDY_CHAIR
affiliation: Children's Hospital Medical Center, Cincinnati
name: James Peugh, Ph.D.
role: STUDY_CHAIR
affiliation: University of California, San Francisco
name: Korey Hood, Ph.D.
role: STUDY_CHAIR
affiliation: BeHealth Solutions, LLC.
name: Lee Ritterband, Ph.D.
role: STUDY_CHAIR
References: