NCT01966744

Self-Management Assistance for Recommended Treatment (SMART) Portal

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 87 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease
• Ulcerative Colitis
• Indeterminate Colitis
• Inflammatory Bowel Disease

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-10-22
• Last updated: 2017-07-19

Locations

2 sites across 1 country: United States