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

2014년 12월 22일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

197

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: 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.
다른: 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.
다른 이름들:
  • 페가시스
  • 리바비린
  • 페그-인트론
  • 빅트렐리스
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • 보세프레비르
다른: 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.
절차: 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.
다른 이름들:
  • 페가시스
  • 리바비린
  • 페그-인트론
  • 빅트렐리스
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • 보세프레비르

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Treatment Duration Compliance Rate
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Drug Exposure
기간: 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.
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Chronic Liver Disease Foundation

협력자

Merck Sharp & Dohme LLC
SCRI Development Innovations, LLC

수사관

  • 수석 연구원: Fred Poordad, MD, Chronic Liver Disease Foundation

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 12월 1일

기본 완료 (실제)

2014년 7월 1일

연구 완료 (실제)

2014년 7월 1일

연구 등록 날짜

최초 제출

2011년 7월 25일

QC 기준을 충족하는 최초 제출

2011년 7월 27일

처음 게시됨 (추정)

2011년 7월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 1월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 12월 22일

마지막으로 확인됨

2014년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CLDF-MER-001-00
  • 20111013 (기타 식별자: Western Institutional Review Board)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다