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

Browse trials for

• Hepatitis A 2,709
• Hepatitis C 2,321
• Hepatitis C, Chronic 1,073
• Hepatitis 3,380

Keywords

• HCV
• Genotype1
• Naive
• Partial responder
• Relapser

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 197 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

This is the only study on the registry with Chronic Liver Disease Foundation as lead sponsor.

Study arms

• Other
  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

• Other
  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

Interventions

• ProcedureEducational 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.

  Also known as: Peg-Intron, Pegasys, Victrelis, Pegylated interferon alfa 2B, Pegylated interferon alfa 2A, Boceprevir, Ribavirin

• OtherPatient 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.

  Also known as: Peg-Intron, Pegasys, Victrelis, Pegylated interferon alfa 2B, Pegylated interferon alfa 2A, Boceprevir, Ribavirin

Primary outcomes

1. Treatment Duration Compliance Rate

   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).

   Time frame: End of treatment up to treatment week 48

Secondary outcomes

1. Drug Exposure

   Total number of patients receiving treatment over specified time intervals.

   Time frame: End of treatment up to treatment week 48

2. Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.

   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.

   Time frame: Follow-up week 24

3. Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)

   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.

   Time frame: Baseline, end of treatment, follow-up week 24

4. Number of Participants With Adverse Events

   Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs

   Time frame: Throughout entire study, at end of treatment and follow up week 24

Baseline characteristics

Publications

• Poordad F, Rustgi V, Brown RS Jr, Patel V, Kugelmas M, Regenstein F, Balart L, LaBrecque D, Brown K, Avila M, Biederman M, Freed G, Smith R, Bernstein M, Arnold H, Cahan J, Fink S, Katkov W, Massoumi H, Harrison S. The impact of an educational program on HCV patient outcomes using boceprevir in community practices (OPTIMAL trial). Therap Adv Gastroenterol. 2015 Sep;8(5):263-9. doi: 10.1177/1756283X15588876. PubMed 26327916 ↗

Related links

• Click here for more information about the Chronic Liver Disease Foundation and Hepatology Centers of Educational Expertise ↗