Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy
OPTIMAL
Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program
2 other identifiers
interventional
197
1 country
43
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2011
Typical duration for phase_4
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2011
CompletedFirst Posted
Study publicly available on registry
July 29, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
January 6, 2015
CompletedJanuary 6, 2015
December 1, 2014
2.6 years
July 25, 2011
November 17, 2014
December 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Duration Compliance Rate
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
Secondary Outcomes (4)
Drug Exposure
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.
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)
Baseline, end of treatment, follow-up week 24
Number of Participants With Adverse Events
Throughout entire study, at end of treatment and follow up week 24
Study Arms (2)
Group A - HCEE
OTHERGroup 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.
Group B - Community Sites
OTHERGroup 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chronic Liver Disease Foundationlead
- SCRI Development Innovations, LLCcollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (43)
California Liver Institute
Beverly Hills, California, 90210, United States
Samuel Burstein, MD
Calabasas, California, 91302, United States
William Katkov, MD
Santa Monica, California, 90404, United States
Sutha Sachar, MD
Torrance, California, 90277, United States
Harbor UCLA Medical Professional Group
Torrance, California, 90509, United States
Associates in Gastroenterology
Colorado Springs, Colorado, 80909, United States
South Denver Gastroenterology
Englewood, Colorado, 80113, United States
Bay Area Gastroenterology
Clearwater, Florida, 33756, United States
Digestive Medicine Associates
Hialeah, Florida, 33016, United States
James Johnson, MD
Lakeland, Florida, 33805, United States
Florida Center for Gastroenterology
Largo, Florida, 33777, United States
Marwan Iskandarani, MD
North Miami Beach, Florida, 33169, United States
Advanced Gastro and Liver Disease
Pinellas Park, Florida, 33781, United States
Lee S. Mitchel, MD
Sarasota, Florida, 34239, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Digestive Disease Consultants
Bourbonnais, Illinois, 60914, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Consultants in Gastroenerology
Munster, Indiana, 46321, United States
Consultants in Gastroenterology
Munster, Indiana, 46321, United States
Wabash Valley Infectious Disease
Terre Haute, Indiana, 47802, United States
University of Iowa Health Center
Iowa City, Iowa, 53342, United States
Metropolitan Gastroenterology Associates
Metairie, Louisiana, 70006, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
South Oakland Gastroenterology
Farmington Hills, Michigan, 48336, United States
Union Lake Clinic
Madison Heights, Michigan, 48071, United States
GI Medicine Associates
Saint Clair Shores, Michigan, 48081, United States
Saint Luke's Health Center
Kansas City, Missouri, 64111, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Michael Fedotin, MD
Kansas City, Missouri, 64132, United States
St. Louis University Liver Center
St Louis, Missouri, 63110, United States
Mercy Digestive Disease
St Louis, Missouri, 63141, United States
North Shore Gastroenterology Associates
Great Neck, New York, 11203, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Columbia University Medical Center
New York, New York, 10032, United States
NY Associates in Gastroenterology
The Bronx, New York, 10461, United States
Temple Physicians
Philadelphia, Pennsylvania, 19134, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Dr. Glenn S. Freed, DO
Pottsville, Pennsylvania, 17901, United States
Main Line Gastroenterology
Wynnewood, Pennsylvania, 19096, United States
Gastroenterology Consultants
Live Oak, Texas, 78233, United States
Brooke Army Medical Center
San Antonio, Texas, 78234, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Medical Associates of Central Virginia
Lynchburg, Virginia, 24501, United States
Related Publications (1)
Poordad F, Rustgi V, Brown RS Jr, Patel V, Kugelmas M, Regenstein F, Balart L, LaBrecque D, Brown K, Avila M, Biederman M, Freed G, Smith R, Bernstein M, Arnold H, Cahan J, Fink S, Katkov W, Massoumi H, Harrison S. The impact of an educational program on HCV patient outcomes using boceprevir in community practices (OPTIMAL trial). Therap Adv Gastroenterol. 2015 Sep;8(5):263-9. doi: 10.1177/1756283X15588876.
PMID: 26327916DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Smaller sample size than expected due to changing treatment landscape for HCV during course of study.
Results Point of Contact
- Title
- Dr. Fred Poordad
- Organization
- Chronic Liver Disease Foundation
Study Officials
- PRINCIPAL INVESTIGATOR
Fred Poordad, MD
Chronic Liver Disease Foundation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2011
First Posted
July 29, 2011
Study Start
December 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
January 6, 2015
Results First Posted
January 6, 2015
Record last verified: 2014-12