Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy (OPTIMAL)
22 décembre 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
197
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Beverly Hills, California, États-Unis, 90210
- California Liver Institute
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Calabasas, California, États-Unis, 91302
- Samuel Burstein, MD
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Santa Monica, California, États-Unis, 90404
- William Katkov, MD
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Torrance, California, États-Unis, 90277
- Sutha Sachar, MD
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Torrance, California, États-Unis, 90509
- Harbor UCLA Medical Professional Group
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Colorado
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Colorado Springs, Colorado, États-Unis, 80909
- Associates in Gastroenterology
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Englewood, Colorado, États-Unis, 80113
- South Denver Gastroenterology
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Florida
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Clearwater, Florida, États-Unis, 33756
- Bay Area Gastroenterology
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Hialeah, Florida, États-Unis, 33016
- Digestive Medicine Associates
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Lakeland, Florida, États-Unis, 33805
- James Johnson, MD
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Largo, Florida, États-Unis, 33777
- Florida Center for Gastroenterology
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North Miami Beach, Florida, États-Unis, 33169
- Marwan Iskandarani, MD
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Pinellas Park, Florida, États-Unis, 33781
- Advanced Gastro and Liver Disease
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Sarasota, Florida, États-Unis, 34239
- Lee S. Mitchel, MD
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Tampa, Florida, États-Unis, 33606
- Tampa General Hospital
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Illinois
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Bourbonnais, Illinois, États-Unis, 60914
- Digestive Disease Consultants
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Indiana University
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Munster, Indiana, États-Unis, 46321
- Consultants in Gastroenerology
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Munster, Indiana, États-Unis, 46321
- Consultants in Gastroenterology
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Terre Haute, Indiana, États-Unis, 47802
- Wabash Valley Infectious Disease
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Iowa
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Iowa City, Iowa, États-Unis, 53342
- University of Iowa Health Center
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Louisiana
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Metairie, Louisiana, États-Unis, 70006
- Metropolitan Gastroenterology Associates
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Michigan
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Health System
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Farmington Hills, Michigan, États-Unis, 48336
- South Oakland Gastroenterology
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Madison Heights, Michigan, États-Unis, 48071
- Union Lake Clinic
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St Clair Shores, Michigan, États-Unis, 48081
- GI Medicine Associates
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Missouri
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Kansas City, Missouri, États-Unis, 64111
- Saint Luke's Hospital
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Kansas City, Missouri, États-Unis, 64111
- Saint Luke's Health Center
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Kansas City, Missouri, États-Unis, 64132
- Michael Fedotin, MD
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St. Louis, Missouri, États-Unis, 63110
- St. Louis University Liver Center
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St. Louis, Missouri, États-Unis, 63141
- Mercy Digestive Disease
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New York
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Bronx, New York, États-Unis, 10461
- NY Associates in Gastroenterology
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Great Neck, New York, États-Unis, 11203
- North Shore Gastroenterology Associates
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Manhasset, New York, États-Unis, 11030
- North Shore University Hospital
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New York, New York, États-Unis, 10032
- Columbia University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19140
- Temple University
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Philadelphia, Pennsylvania, États-Unis, 19134
- Temple Physicians
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Pottsville, Pennsylvania, États-Unis, 17901
- Dr. Glenn S. Freed, DO
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Wynnewood, Pennsylvania, États-Unis, 19096
- Main Line Gastroenterology
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Texas
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Live Oak, Texas, États-Unis, 78233
- Gastroenterology Consultants
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San Antonio, Texas, États-Unis, 78234
- Brooke Army Medical Center
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Virginia
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Fairfax, Virginia, États-Unis, 22031
- Metropolitan Research
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Lynchburg, Virginia, États-Unis, 24501
- Medical Associates of Central Virginia
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: 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.
Autres noms:
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Autre: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Treatment Duration Compliance Rate
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Drug Exposure
Délai: 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.
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Fred Poordad, MD, Chronic Liver Disease Foundation
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2011
Achèvement primaire (Réel)
1 juillet 2014
Achèvement de l'étude (Réel)
1 juillet 2014
Dates d'inscription aux études
Première soumission
25 juillet 2011
Première soumission répondant aux critères de contrôle qualité
27 juillet 2011
Première publication (Estimation)
29 juillet 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
6 janvier 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 décembre 2014
Dernière vérification
1 décembre 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies du foie
- Infections à Flaviviridae
- Hépatite, virale, humaine
- Infections à entérovirus
- Infections à Picornaviridae
- Hépatite chronique
- Hépatite
- Hépatite A
- Hépatite C
- Hépatite C chronique
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Antimétabolites
- Agents antinéoplasiques
- Facteurs immunologiques
- Interférons
- Interféron-alpha
- Ribavirine
- Peginterféron alfa-2a
- Interféron alpha-2
- Peginterféron alfa-2b
Autres numéros d'identification d'étude
- CLDF-MER-001-00
- 20111013 (Autre identifiant: Western Institutional Review Board)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .