Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy (OPTIMAL)
|ClinicalTrials.gov Identifier: NCT01405027|
Recruitment Status : Completed
First Posted : July 29, 2011
Results First Posted : January 6, 2015
Last Update Posted : January 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Genotype 1||Procedure: Educational Intervention Other: Patient education and management skills training||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||197 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program|
|Study Start Date :||December 2011|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
Group A - HCEE
Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor. HCEE investigators provided patient education and management skills training during four (4) educational interventions to Community Site investigators.
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.
Group B - Community Sites
Group B - community physicians treating HCV but without clinical trial experience with an HCV protease inhibitor received patient education and management skills training from Hepatology Centers of Educational Expertise (HCEEs) during four (4) educational interventions.
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.
- Treatment Duration Compliance Rate [ Time Frame: End of treatment up to treatment week 48 ]The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).
- Drug Exposure [ Time Frame: End of treatment up to treatment week 48 ]Total number of patients receiving treatment over specified time intervals.
- Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs. [ Time Frame: Follow-up week 24 ]Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.
- Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) [ Time Frame: Baseline, end of treatment, follow-up week 24 ]
Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs.
Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life.
- Number of Participants With Adverse Events [ Time Frame: Throughout entire study, at end of treatment and follow up week 24 ]Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405027
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|Principal Investigator:||Fred Poordad, MD||Chronic Liver Disease Foundation|