Self-Management Assistance for Recommended Treatment (SMART) Portal

Ulcerative Colitis Clinical Trial

— SMART  

Official title:

Self-Management Assistance for Recommended Treatment (SMART) Portal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966744
• Other study ID #: SMART
• Status: Completed
• Phase: N/A
• First received: October 4, 2013
• Last updated: July 18, 2017
• Start date: July 2013
• Est. completion date: June 2016

Study information

• Verified date: July 2017
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	BeHealth Solutions, LLC	Charlottesville	Virginia
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	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.	Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Secondary	Disease severity	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.	Phase 3 - Approximately 2-6 months, depending upon progression through portal components
Secondary	Health-related quality of life	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.	Phase 3 - Approximately 2-6 months, depending upon progression through portal components