NCT01405027

Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy

Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Chronic Liver Disease Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.

Detailed description

The new treatment paradigm for HCV in the era of protease inhibitors will add a level of complexity that was previously not seen with pegylated interferon and ribavirin. In addition to new concepts such as utilization of a lead-in period, compliance with a TID dosing regimen of a third agent, development of resistance, and futility rules and decision points have yet to be assessed in a real life practice setting. The OPTIMAL trial is designed to evaluate the impact of an education program for community sites participating in a CLDF study treating chronic HCV genotype 1 patients. Group A will be comprised of approximately 30 CLDF designated Hepatology Centers of Educational Expertise (HCEE) and Group B will be comprised of approximately 60 community sites. Group A will also deliver the educational program regarding the use of HCV protease inhibitors, and the overall treatment of HCV to approximately two (2) community sites in it's geographic region. Group B will be comprised of community sites that have no previous clinical trial experience with boceprevir or an HCV protease inhibitor. For the purpose of this study, each community site in Group B will be assigned to an HCEE.

Conditions

• Chronic Hepatitis C
• Genotype 1

Interventions

Type	Name	Description
PROCEDURE	Educational Intervention	Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.
OTHER	Patient education and management skills training	Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-07-29
• Last updated: 2015-01-06
• Results posted: 2015-01-06

Locations

43 sites across 1 country: United States