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

2014年12月22日 更新者：Chronic Liver Disease Foundation

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

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

197

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Beverly Hills、California、美国、90210
        • California Liver Institute
      • Calabasas、California、美国、91302
        • Samuel Burstein, MD
      • Santa Monica、California、美国、90404
        • William Katkov, MD
      • Torrance、California、美国、90277
        • Sutha Sachar, MD
      • Torrance、California、美国、90509
        • Harbor UCLA Medical Professional Group
    • Colorado
      • Colorado Springs、Colorado、美国、80909
        • Associates in Gastroenterology
      • Englewood、Colorado、美国、80113
        • South Denver Gastroenterology
    • Florida
      • Clearwater、Florida、美国、33756
        • Bay Area Gastroenterology
      • Hialeah、Florida、美国、33016
        • Digestive Medicine Associates
      • Lakeland、Florida、美国、33805
        • James Johnson, MD
      • Largo、Florida、美国、33777
        • Florida Center for Gastroenterology
      • North Miami Beach、Florida、美国、33169
        • Marwan Iskandarani, MD
      • Pinellas Park、Florida、美国、33781
        • Advanced Gastro and Liver Disease
      • Sarasota、Florida、美国、34239
        • Lee S. Mitchel, MD
      • Tampa、Florida、美国、33606
        • Tampa General Hospital
    • Illinois
      • Bourbonnais、Illinois、美国、60914
        • Digestive Disease Consultants
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Indiana University
      • Munster、Indiana、美国、46321
        • Consultants in Gastroenerology
      • Munster、Indiana、美国、46321
        • Consultants in Gastroenterology
      • Terre Haute、Indiana、美国、47802
        • Wabash Valley Infectious Disease
    • Iowa
      • Iowa City、Iowa、美国、53342
        • University of Iowa Health Center
    • Louisiana
      • Metairie、Louisiana、美国、70006
        • Metropolitan Gastroenterology Associates
    • Michigan
      • Detroit、Michigan、美国、48202
        • Henry Ford Health System
      • Farmington Hills、Michigan、美国、48336
        • South Oakland Gastroenterology
      • Madison Heights、Michigan、美国、48071
        • Union Lake Clinic
      • St Clair Shores、Michigan、美国、48081
        • GI Medicine Associates
    • Missouri
      • Kansas City、Missouri、美国、64111
        • Saint Luke's Hospital
      • Kansas City、Missouri、美国、64111
        • Saint Luke's Health Center
      • Kansas City、Missouri、美国、64132
        • Michael Fedotin, MD
      • St. Louis、Missouri、美国、63110
        • St. Louis University Liver Center
      • St. Louis、Missouri、美国、63141
        • Mercy Digestive Disease
    • New York
      • Bronx、New York、美国、10461
        • NY Associates in Gastroenterology
      • Great Neck、New York、美国、11203
        • North Shore Gastroenterology Associates
      • Manhasset、New York、美国、11030
        • North Shore University Hospital
      • New York、New York、美国、10032
        • Columbia University Medical Center
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19140
        • Temple University
      • Philadelphia、Pennsylvania、美国、19134
        • Temple Physicians
      • Pottsville、Pennsylvania、美国、17901
        • Dr. Glenn S. Freed, DO
      • Wynnewood、Pennsylvania、美国、19096
        • Main Line Gastroenterology
    • Texas
      • Live Oak、Texas、美国、78233
        • Gastroenterology Consultants
      • San Antonio、Texas、美国、78234
        • Brooke Army Medical Center
    • Virginia
      • Fairfax、Virginia、美国、22031
        • Metropolitan Research
      • Lynchburg、Virginia、美国、24501
        • Medical Associates of Central Virginia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Chronic Hepatitis C (HCV) genotype 1
  • Detectable HCV-RNA within 180 days of screening
  • Age ≥ 18 years
  • Weight > 40 kg
  • Patient and partner(s) must agree to use acceptable methods of contraception
  • Written informed consent

Exclusion Criteria:

  • Known co-infection with HIV or HBV
  • Previous interferon or ribavirin regimen requiring discontinuation for an adverse event considered related to ribavirin and/or interferon
  • Currently taking or planning on taking any prohibited medications
  • Evidence of decompensated liver disease including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
  • Diabetes and/or hypertension with clinically significant ocular examination findings
  • Pre-existing psychiatric condition(s)
  • History of severe and uncontrolled psychiatric disorders
  • Active alcohol or drug abuse (not including marijuana)
  • Pre-existing medical condition that could interfere with the patient's participation in the study
  • Chronic obstructive pulmonary disease
  • Abnormal lab values

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：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.
其他：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.
其他名称：
  • 飞马座
  • 利巴韦林
  • 佩格内含子
  • 维氏
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • 波普瑞韦
其他：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.
程序：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.
其他名称：
  • 飞马座
  • 利巴韦林
  • 佩格内含子
  • 维氏
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • 波普瑞韦

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Treatment Duration Compliance Rate
大体时间：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).
End of treatment up to treatment week 48

次要结果测量

结果测量
措施说明
大体时间
Drug Exposure
大体时间：End of treatment up to treatment week 48
Total number of patients receiving treatment over specified time intervals.
End of treatment up to treatment week 48
Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.
大体时间：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.
Follow-up week 24
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
大体时间：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.
Baseline, end of treatment, follow-up week 24
Number of Participants With Adverse Events
大体时间：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
Throughout entire study, at end of treatment and follow up week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chronic Liver Disease Foundation

合作者

Merck Sharp & Dohme LLC
SCRI Development Innovations, LLC

调查人员

  • 首席研究员：Fred Poordad, MD、Chronic Liver Disease Foundation

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年12月1日

初级完成 (实际的)

2014年7月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2011年7月25日

首先提交符合 QC 标准的

2011年7月27日

首次发布 (估计)

2011年7月29日

研究记录更新

最后更新发布 (估计)

2015年1月6日

上次提交的符合 QC 标准的更新

2014年12月22日

最后验证

2014年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CLDF-MER-001-00
  • 20111013 (其他标识符：Western Institutional Review Board)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

罕见疾病

药物干预

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赞助者/合作者

地点

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