Trial Outcomes & Findings for Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy (NCT NCT01405027)
NCT ID: NCT01405027
Last Updated: 2015-01-06
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
197 participants
Primary outcome timeframe
End of treatment up to treatment week 48
Results posted on
2015-01-06
Participant Flow
Participant milestones
| Measure |
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.
No Intervention: Deliver patient education and management skills training to community sites 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.
|
Group B - Community Sites
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
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.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
113
|
|
Overall Study
COMPLETED
|
52
|
62
|
|
Overall Study
NOT COMPLETED
|
32
|
51
|
Reasons for withdrawal
| Measure |
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.
No Intervention: Deliver patient education and management skills training to community sites 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.
|
Group B - Community Sites
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
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.
|
|---|---|---|
|
Overall Study
Withdrawn consent
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
16
|
24
|
|
Overall Study
Investigator judgement
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Other or Unknown
|
12
|
25
|
Baseline Characteristics
Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy
Baseline characteristics by cohort
| Measure |
Group A - HCEE
n=84 Participants
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.
No Intervention: Deliver patient education and management skills training to community sites 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.
|
Group B - Community Sites
n=113 Participants
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
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.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 11.37 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 11.27 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
50 participants
n=5 Participants
|
75 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
19 participants
n=5 Participants
|
23 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Patient Status
Treatment Naive
|
30 participants
n=5 Participants
|
69 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Patient Status
Previous Partial Responder
|
12 participants
n=5 Participants
|
5 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Patient Status
Relapsed
|
17 participants
n=5 Participants
|
22 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Patient Status
Compensated Cirrhotic
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Patient Status
Historic Null Responder
|
16 participants
n=5 Participants
|
9 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Hepatitis C Virus Genotype
1a
|
62 participants
n=5 Participants
|
76 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Hepatitis C Virus Genotype
1b
|
22 participants
n=5 Participants
|
35 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Hepatitis C Virus Genotype
Missing
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of treatment up to treatment week 48Population: Population analyzed represents patients who had a PCR at treatment weeks where expected duration of treatment could have been determined. Subjects who discontinued the study due to Treatment Futility were considered to have 100% treatment duration compliance.
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).
Outcome measures
| Measure |
Group A - HCEE
n=77 Participants
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.
No Intervention: Deliver patient education and management skills training to community sites 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.
|
Group B - Community Sites
n=102 Participants
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
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.
|
|---|---|---|
|
Treatment Duration Compliance Rate
|
85.4 Percentage of compliance
Interval 79.7 to 91.2
|
83.8 Percentage of compliance
Interval 78.4 to 89.2
|
SECONDARY outcome
Timeframe: End of treatment up to treatment week 48Total number of patients receiving treatment over specified time intervals.
Outcome measures
| Measure |
Group A - HCEE
n=84 Participants
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.
No Intervention: Deliver patient education and management skills training to community sites 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.
|
Group B - Community Sites
n=113 Participants
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
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.
|
|---|---|---|
|
Drug Exposure
Days 1-7
|
84 participants
|
113 participants
|
|
Drug Exposure
Days 8-14
|
84 participants
|
112 participants
|
|
Drug Exposure
Days 15-28
|
83 participants
|
110 participants
|
|
Drug Exposure
Days 29-56
|
81 participants
|
108 participants
|
|
Drug Exposure
Days 57-84
|
78 participants
|
100 participants
|
|
Drug Exposure
Days 85-168
|
73 participants
|
91 participants
|
|
Drug Exposure
Days 169-252
|
49 participants
|
75 participants
|
|
Drug Exposure
Days >252
|
26 participants
|
30 participants
|
SECONDARY outcome
Timeframe: Follow-up week 24Population: Follow-up SVR includes data collected 10 weeks or greater from last treatment.
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.
Outcome measures
| Measure |
Group A - HCEE
n=84 Participants
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.
No Intervention: Deliver patient education and management skills training to community sites 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.
|
Group B - Community Sites
n=113 Participants
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
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.
|
|---|---|---|
|
Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.
Negative (percent)
|
48.8 percentage of participants
|
46.0 percentage of participants
|
|
Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.
Positive (percent)
|
23.8 percentage of participants
|
26.5 percentage of participants
|
|
Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.
Missing (percent)
|
27.4 percentage of participants
|
27.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, end of treatment, follow-up week 24Population: The Quality of Life scores are derived from the responses from subjects who completed questionnaires at protocol-scheduled timepoints.
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.
Outcome measures
| Measure |
Group A - HCEE
n=77 Participants
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.
No Intervention: Deliver patient education and management skills training to community sites 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.
|
Group B - Community Sites
n=109 Participants
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
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.
|
|---|---|---|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Physical Component Score - baseline
|
44.6 score
Standard Deviation 12.58
|
45.5 score
Standard Deviation 11.80
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Emotional Role Functioning - Follow-up week
|
85.6 score
Standard Deviation 31.66
|
82.0 score
Standard Deviation 32.01
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Mental Health - Baseline
|
76.4 score
Standard Deviation 16.89
|
76.6 score
Standard Deviation 18.45
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Mental Health - End of treatment
|
69.5 score
Standard Deviation 19.61
|
68.5 score
Standard Deviation 17.36
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Mental Health - Follow-up week
|
83.3 score
Standard Deviation 15.34
|
77.2 score
Standard Deviation 15.74
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Physical Component Score - End of treatment
|
42.9 score
Standard Deviation 10.38
|
43.7 score
Standard Deviation 9.21
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Physical Component Score - Follow-up week
|
49.2 score
Standard Deviation 8.75
|
49.4 score
Standard Deviation 11.34
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Mental Component Score - Baseline
|
52.2 score
Standard Deviation 8.78
|
51.4 score
Standard Deviation 9.08
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Mental Component Score - End of treatment
|
45.3 score
Standard Deviation 10.68
|
45.2 score
Standard Deviation 10.05
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Mental Component Score - Follow-up week
|
54.8 score
Standard Deviation 8.49
|
51.9 score
Standard Deviation 8.44
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Physical Functioning - Baseline
|
76.1 score
Standard Deviation 29.27
|
77.1 score
Standard Deviation 26.23
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Physical Functioning - End of treatment
|
68.3 score
Standard Deviation 26.45
|
70.3 score
Standard Deviation 24.00
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Physical Functioning - Follow-up week
|
84.2 score
Standard Deviation 24.35
|
82.3 score
Standard Deviation 24.19
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Physical Role Functioning - Baseline
|
71.0 score
Standard Deviation 40.16
|
68.0 score
Standard Deviation 41.22
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Physical Role Functioning - End of treatment
|
47.1 score
Standard Deviation 42.96
|
47.0 score
Standard Deviation 42.76
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Physical Role Functioning - Follow-up week
|
80.7 score
Standard Deviation 31.38
|
81.8 score
Standard Deviation 33.67
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Bodily Pain - Baseline
|
63.1 score
Standard Deviation 29.62
|
68.9 score
Standard Deviation 29.02
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Bodily Pain - End of treatment
|
65.1 score
Standard Deviation 24.89
|
66.0 score
Standard Deviation 22.04
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Bodily Pain - Follow-up week
|
76.7 score
Standard Deviation 24.33
|
73.8 score
Standard Deviation 27.60
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
General Health - Baseline
|
67.7 score
Standard Deviation 21.44
|
65.7 score
Standard Deviation 23.42
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
General Health - End of treatment
|
65.9 score
Standard Deviation 21.93
|
69.0 score
Standard Deviation 20.05
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
General Health - Follow-up week
|
74.6 score
Standard Deviation 18.28
|
74.0 score
Standard Deviation 19.24
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Vitality - Baseline
|
57.5 score
Standard Deviation 23.75
|
58.2 score
Standard Deviation 23.12
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Vitality - End of treatment
|
44.6 score
Standard Deviation 25.55
|
43.0 score
Standard Deviation 23.61
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Vitality - Follow-up week
|
71.7 score
Standard Deviation 20.37
|
65.7 score
Standard Deviation 18.86
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Social Functioning - Baseline
|
82.4 score
Standard Deviation 24.21
|
82.8 score
Standard Deviation 24.70
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Social Functioning - End of treatment
|
66.0 score
Standard Deviation 26.35
|
67.9 score
Standard Deviation 25.86
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Social Functioning - Follow-up week
|
89.8 score
Standard Deviation 16.89
|
87.2 score
Standard Deviation 18.04
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Emotional Role Functioning - Baseline
|
86.6 score
Standard Deviation 28.75
|
80.3 score
Standard Deviation 34.18
|
|
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Emotional Role Functioning - End of treatment
|
61.1 score
Standard Deviation 42.15
|
64.2 score
Standard Deviation 42.76
|
SECONDARY outcome
Timeframe: Throughout entire study, at end of treatment and follow up week 24Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs
Outcome measures
| Measure |
Group A - HCEE
n=84 Participants
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.
No Intervention: Deliver patient education and management skills training to community sites 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.
|
Group B - Community Sites
n=113 Participants
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
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.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
77 participants
|
95 participants
|
Adverse Events
Group A - HCEE
Serious events: 6 serious events
Other events: 77 other events
Deaths: 0 deaths
Group B - Community Sites
Serious events: 8 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A - HCEE
n=84 participants at risk
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.
No Intervention: Deliver patient education and management skills training to community sites 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.
|
Group B - Community Sites
n=113 participants at risk
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
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.
|
|---|---|---|
|
General disorders
Fatigue
|
1.2%
1/84
|
0.00%
0/113
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/84
|
0.88%
1/113
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/84
|
0.88%
1/113
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/84
|
1.8%
2/113
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/84
|
0.88%
1/113
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/84
|
0.88%
1/113
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/84
|
0.00%
0/113
|
|
Psychiatric disorders
Depression
|
1.2%
1/84
|
0.88%
1/113
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/84
|
0.88%
1/113
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/84
|
0.88%
1/113
|
|
Nervous system disorders
Stroke
|
1.2%
1/84
|
0.00%
0/113
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/84
|
0.00%
0/113
|
Other adverse events
| Measure |
Group A - HCEE
n=84 participants at risk
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.
No Intervention: Deliver patient education and management skills training to community sites 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.
|
Group B - Community Sites
n=113 participants at risk
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.0%
5/84
|
6.2%
7/113
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.2%
22/84
|
8.8%
10/113
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
9/84
|
2.7%
3/113
|
|
Psychiatric disorders
Insomnia
|
22.6%
19/84
|
14.2%
16/113
|
|
Psychiatric disorders
Depression
|
17.9%
15/84
|
9.7%
11/113
|
|
Psychiatric disorders
Anxiety
|
6.0%
5/84
|
5.3%
6/113
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.1%
11/84
|
5.3%
6/113
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.9%
10/84
|
10.6%
12/113
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.1%
11/84
|
8.8%
10/113
|
|
Investigations
Weight decreased
|
4.8%
4/84
|
6.2%
7/113
|
|
Endocrine disorders
Hypothyroidism
|
3.6%
3/84
|
6.2%
7/113
|
|
General disorders
Fatigue
|
64.3%
54/84
|
24.8%
28/113
|
|
General disorders
Irritability
|
14.3%
12/84
|
2.7%
3/113
|
|
General disorders
Influenza like Illness
|
11.9%
10/84
|
1.8%
2/113
|
|
General disorders
Pyrexia
|
11.9%
10/84
|
2.7%
3/113
|
|
General disorders
Malaise
|
2.4%
2/84
|
8.0%
9/113
|
|
Gastrointestinal disorders
Nausea
|
42.9%
36/84
|
22.1%
25/113
|
|
Gastrointestinal disorders
Diarrhoea
|
23.8%
20/84
|
13.3%
15/113
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
9/84
|
6.2%
7/113
|
|
Gastrointestinal disorders
Constipation
|
6.0%
5/84
|
8.8%
10/113
|
|
Gastrointestinal disorders
Stomatitis
|
6.0%
5/84
|
4.4%
5/113
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
42/84
|
38.9%
44/113
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.4%
18/84
|
17.7%
20/113
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.5%
8/84
|
15.0%
17/113
|
|
Nervous system disorders
Headache
|
26.2%
22/84
|
15.0%
17/113
|
|
Nervous system disorders
Dysgeusia
|
19.0%
16/84
|
15.0%
17/113
|
|
Nervous system disorders
Dizziness
|
13.1%
11/84
|
8.0%
9/113
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
24/84
|
23.9%
27/113
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
14/84
|
7.1%
8/113
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60