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

22. december 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

197

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Andet: 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.
Andre navne:
  • Pegasys
  • Ribavirin
  • Peg-Intron
  • Victrelis
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • Boceprevir
Andet: 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.
Andre navne:
  • Pegasys
  • Ribavirin
  • Peg-Intron
  • Victrelis
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • Boceprevir

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment Duration Compliance Rate
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Drug Exposure
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chronic Liver Disease Foundation

Samarbejdspartnere

Merck Sharp & Dohme LLC
SCRI Development Innovations, LLC

Efterforskere

  • Ledende efterforsker: Fred Poordad, MD, Chronic Liver Disease Foundation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2011

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først indsendt

25. juli 2011

Først indsendt, der opfyldte QC-kriterier

27. juli 2011

Først opslået (Skøn)

29. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. januar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. december 2014

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLDF-MER-001-00
  • 20111013 (Anden identifikator: Western Institutional Review Board)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk hepatitis C

Kliniske forsøg med Patient education and management skills training

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Venezuela

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner