Self-Management Assistance for Recommended Treatment (SMART) Portal

Completed

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

• Registration Number: NCT01966744
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-10-04
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-22
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medication adherence	Phase 3 - Approximately 2-6 months, depending upon progression through portal components	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.

Secondary Outcome Measures

Name	Time	Method
Disease severity	Phase 3 - Approximately 2-6 months, depending upon progression through portal components	Disease severity will be measured at baseline, post-treatment, and periodically throughout the intervention as the patient logs in to view intervention materials during Phase 3. The portal will prompt the patient to complete disease severity questions throughout the intervention, but it will be dependent upon the patient actually logging into the system. Therefore, exact time points during treatment are unknown. The Pediatric Ulcerative Colitis Activity Index (PUCAI) will be used to measure disease severity for patients diagnosed with ulcerative colitis and indeterminate colitis, and the Partial Harvey Bradshaw (PHBI) will be used for patients diagnosed with Crohn's disease. Phase 3 will start approximately in October 2014 and continue through March 2015.
Health-related quality of life	Phase 3 - Approximately 2-6 months, depending upon progression through portal components	The IMPACT-III will be used during baseline and post-treatment in Phase 3 to measure quality of life in patients. Phase 3 will start approximately in October 2014 and continue through March 2015.

Trial Locations

Locations (2)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

BeHealth Solutions, LLC; 🇺🇸 Charlottesville, Virginia, United States