Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy (OPTIMAL)
22 de diciembre de 2014 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
197
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Beverly Hills, California, Estados Unidos, 90210
- California Liver Institute
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Calabasas, California, Estados Unidos, 91302
- Samuel Burstein, MD
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Santa Monica, California, Estados Unidos, 90404
- William Katkov, MD
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Torrance, California, Estados Unidos, 90277
- Sutha Sachar, MD
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Torrance, California, Estados Unidos, 90509
- Harbor UCLA Medical Professional Group
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80909
- Associates in Gastroenterology
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Englewood, Colorado, Estados Unidos, 80113
- South Denver Gastroenterology
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Florida
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Clearwater, Florida, Estados Unidos, 33756
- Bay Area Gastroenterology
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Hialeah, Florida, Estados Unidos, 33016
- Digestive Medicine Associates
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Lakeland, Florida, Estados Unidos, 33805
- James Johnson, MD
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Largo, Florida, Estados Unidos, 33777
- Florida Center for Gastroenterology
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North Miami Beach, Florida, Estados Unidos, 33169
- Marwan Iskandarani, MD
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Pinellas Park, Florida, Estados Unidos, 33781
- Advanced Gastro and Liver Disease
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Sarasota, Florida, Estados Unidos, 34239
- Lee S. Mitchel, MD
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Tampa, Florida, Estados Unidos, 33606
- Tampa General Hospital
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Illinois
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Bourbonnais, Illinois, Estados Unidos, 60914
- Digestive Disease Consultants
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University
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Munster, Indiana, Estados Unidos, 46321
- Consultants in Gastroenerology
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Munster, Indiana, Estados Unidos, 46321
- Consultants in Gastroenterology
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Terre Haute, Indiana, Estados Unidos, 47802
- Wabash Valley Infectious Disease
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Iowa
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Iowa City, Iowa, Estados Unidos, 53342
- University of Iowa Health Center
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70006
- Metropolitan Gastroenterology Associates
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Health System
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Farmington Hills, Michigan, Estados Unidos, 48336
- South Oakland Gastroenterology
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Madison Heights, Michigan, Estados Unidos, 48071
- Union Lake Clinic
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St Clair Shores, Michigan, Estados Unidos, 48081
- GI Medicine Associates
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Missouri
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Kansas City, Missouri, Estados Unidos, 64111
- Saint Luke's Hospital
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Kansas City, Missouri, Estados Unidos, 64111
- Saint Luke's Health Center
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Kansas City, Missouri, Estados Unidos, 64132
- Michael Fedotin, MD
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St. Louis, Missouri, Estados Unidos, 63110
- St. Louis University Liver Center
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St. Louis, Missouri, Estados Unidos, 63141
- Mercy Digestive Disease
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New York
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Bronx, New York, Estados Unidos, 10461
- NY Associates in Gastroenterology
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Great Neck, New York, Estados Unidos, 11203
- North Shore Gastroenterology Associates
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Manhasset, New York, Estados Unidos, 11030
- North Shore University Hospital
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New York, New York, Estados Unidos, 10032
- Columbia University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- Temple University
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Philadelphia, Pennsylvania, Estados Unidos, 19134
- Temple Physicians
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Pottsville, Pennsylvania, Estados Unidos, 17901
- Dr. Glenn S. Freed, DO
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Wynnewood, Pennsylvania, Estados Unidos, 19096
- Main Line Gastroenterology
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Texas
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Live Oak, Texas, Estados Unidos, 78233
- Gastroenterology Consultants
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San Antonio, Texas, Estados Unidos, 78234
- Brooke Army Medical Center
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Virginia
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Fairfax, Virginia, Estados Unidos, 22031
- Metropolitan Research
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Lynchburg, Virginia, Estados Unidos, 24501
- Medical Associates of Central Virginia
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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.
Otros nombres:
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Otro: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Treatment Duration Compliance Rate
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Drug Exposure
Periodo de tiempo: End of treatment up to treatment week 48
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Total number of patients receiving treatment over specified time intervals.
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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.
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Fred Poordad, MD, Chronic Liver Disease Foundation
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2011
Finalización primaria (Actual)
1 de julio de 2014
Finalización del estudio (Actual)
1 de julio de 2014
Fechas de registro del estudio
Enviado por primera vez
25 de julio de 2011
Primero enviado que cumplió con los criterios de control de calidad
27 de julio de 2011
Publicado por primera vez (Estimar)
29 de julio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de enero de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
22 de diciembre de 2014
Última verificación
1 de diciembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Hepatitis Crónica
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C Crónica
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Antimetabolitos
- Agentes antineoplásicos
- Factores inmunológicos
- Interferones
- Interferón-alfa
- Ribavirina
- Peginterferón alfa-2a
- Interferón alfa-2
- Peginterferón alfa-2b
Otros números de identificación del estudio
- CLDF-MER-001-00
- 20111013 (Otro identificador: Western Institutional Review Board)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .