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

22 dicembre 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

197

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.
Altro: 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.
Altri nomi:
  • Pegasys
  • Ribavirina
  • Peg-Intron
  • Victrelis
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • Boceprevir
Altro: 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.
Procedura: 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.
Altri nomi:
  • Pegasys
  • Ribavirina
  • Peg-Intron
  • Victrelis
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • Boceprevir

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment Duration Compliance Rate
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Drug Exposure
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chronic Liver Disease Foundation

Collaboratori

Merck Sharp & Dohme LLC
SCRI Development Innovations, LLC

Investigatori

  • Investigatore principale: Fred Poordad, MD, Chronic Liver Disease Foundation

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2011

Completamento primario (Effettivo)

1 luglio 2014

Completamento dello studio (Effettivo)

1 luglio 2014

Date di iscrizione allo studio

Primo inviato

25 luglio 2011

Primo inviato che soddisfa i criteri di controllo qualità

27 luglio 2011

Primo Inserito (Stima)

29 luglio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 gennaio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 dicembre 2014

Ultimo verificato

1 dicembre 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CLDF-MER-001-00
  • 20111013 (Altro identificatore: Western Institutional Review Board)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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