Self-Management Assistance for Recommended Treatment (SMART) Portal

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease; Indeterminate Colitis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01966744

SMART

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

87 participants in 3 patient groups

Clinicians/Nurses

Description:

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

Description:

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

Description:

Caregivers of patients diagnosed with IBD will be recruited to interact with and use the SMART portal to provide feedback on optimization.