Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy (OPTIMAL)
22. desember 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
197
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Beverly Hills, California, Forente stater, 90210
- California Liver Institute
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Calabasas, California, Forente stater, 91302
- Samuel Burstein, MD
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Santa Monica, California, Forente stater, 90404
- William Katkov, MD
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Torrance, California, Forente stater, 90277
- Sutha Sachar, MD
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Torrance, California, Forente stater, 90509
- Harbor UCLA Medical Professional Group
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Colorado
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Colorado Springs, Colorado, Forente stater, 80909
- Associates in Gastroenterology
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Englewood, Colorado, Forente stater, 80113
- South Denver Gastroenterology
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Florida
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Clearwater, Florida, Forente stater, 33756
- Bay Area Gastroenterology
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Hialeah, Florida, Forente stater, 33016
- Digestive Medicine Associates
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Lakeland, Florida, Forente stater, 33805
- James Johnson, MD
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Largo, Florida, Forente stater, 33777
- Florida Center for Gastroenterology
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North Miami Beach, Florida, Forente stater, 33169
- Marwan Iskandarani, MD
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Pinellas Park, Florida, Forente stater, 33781
- Advanced Gastro and Liver Disease
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Sarasota, Florida, Forente stater, 34239
- Lee S. Mitchel, MD
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Tampa, Florida, Forente stater, 33606
- Tampa General Hospital
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Illinois
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Bourbonnais, Illinois, Forente stater, 60914
- Digestive Disease Consultants
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Indiana University
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Munster, Indiana, Forente stater, 46321
- Consultants in Gastroenerology
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Munster, Indiana, Forente stater, 46321
- Consultants in Gastroenterology
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Terre Haute, Indiana, Forente stater, 47802
- Wabash Valley Infectious Disease
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Iowa
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Iowa City, Iowa, Forente stater, 53342
- University of Iowa Health Center
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Louisiana
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Metairie, Louisiana, Forente stater, 70006
- Metropolitan Gastroenterology Associates
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Health System
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Farmington Hills, Michigan, Forente stater, 48336
- South Oakland Gastroenterology
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Madison Heights, Michigan, Forente stater, 48071
- Union Lake Clinic
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St Clair Shores, Michigan, Forente stater, 48081
- GI Medicine Associates
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- Saint Luke's Hospital
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Kansas City, Missouri, Forente stater, 64111
- Saint Luke's Health Center
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Kansas City, Missouri, Forente stater, 64132
- Michael Fedotin, MD
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St. Louis, Missouri, Forente stater, 63110
- St. Louis University Liver Center
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St. Louis, Missouri, Forente stater, 63141
- Mercy Digestive Disease
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New York
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Bronx, New York, Forente stater, 10461
- NY Associates in Gastroenterology
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Great Neck, New York, Forente stater, 11203
- North Shore Gastroenterology Associates
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Manhasset, New York, Forente stater, 11030
- North Shore University Hospital
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New York, New York, Forente stater, 10032
- Columbia University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19140
- Temple University
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Philadelphia, Pennsylvania, Forente stater, 19134
- Temple Physicians
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Pottsville, Pennsylvania, Forente stater, 17901
- Dr. Glenn S. Freed, DO
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Wynnewood, Pennsylvania, Forente stater, 19096
- Main Line Gastroenterology
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Texas
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Live Oak, Texas, Forente stater, 78233
- Gastroenterology Consultants
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San Antonio, Texas, Forente stater, 78234
- Brooke Army Medical Center
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Virginia
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Fairfax, Virginia, Forente stater, 22031
- Metropolitan Research
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Lynchburg, Virginia, Forente stater, 24501
- Medical Associates of Central Virginia
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: 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.
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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 navn:
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Annen: 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.
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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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment Duration Compliance Rate
Tidsramme: End of treatment up to treatment week 48
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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).
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End of treatment up to treatment week 48
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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
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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.
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Follow-up week 24
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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
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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
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Number of Participants With Adverse Events
Tidsramme: Throughout entire study, at end of treatment and follow up week 24
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Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs
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Throughout entire study, at end of treatment and follow up week 24
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Fred Poordad, MD, Chronic Liver Disease Foundation
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2011
Primær fullføring (Faktiske)
1. juli 2014
Studiet fullført (Faktiske)
1. juli 2014
Datoer for studieregistrering
Først innsendt
25. juli 2011
Først innsendt som oppfylte QC-kriteriene
27. juli 2011
Først lagt ut (Anslag)
29. juli 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. januar 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Leversykdommer
- Flaviviridae-infeksjoner
- Hepatitt, viral, menneskelig
- Enterovirusinfeksjoner
- Picornaviridae-infeksjoner
- Hepatitt, kronisk
- Hepatitt
- Hepatitt A-virus
- Hepatitt C
- Hepatitt C, kronisk
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Antimetabolitter
- Antineoplastiske midler
- Immunologiske faktorer
- Interferoner
- Interferon-alfa
- Ribavirin
- Peginterferon alfa-2a
- Interferon alfa-2
- Peginterferon alfa-2b
Andre studie-ID-numre
- CLDF-MER-001-00
- 20111013 (Annen identifikator: Western Institutional Review Board)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .