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ISRCTN
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ISRCTN12471415
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ClinicalTrials.gov identifier
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Public title
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Effectiveness of patient support programme for the treatment of hepatitis C
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Since there is no hepatitis C vaccine available for primary prevention, health education is the most important control strategy in containing the impact of hepatitis C. The hypothesis of this study is that effective patient support programs could improve the compliance to treatment and outcome of hepatitis C patients.
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Lay summary
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Ethics approval
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The institutional review board approved the protocol and all patients provided a written informed consent. The date and reference number of ethical approval for our trial is 10/10/2004 and F-950208.
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Study design
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Interventional randomised controlled study
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Countries of recruitment
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Taiwan
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Disease/condition/study domain
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Chronic hepatitis C
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Participants - inclusion criteria
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Adult patients who have never received interferon and who had at least 2000 copies of HCV ribonucleic acid per ml (RNA/ml) of serum with polymerase chain reaction (PCR) assay, serum aspartate aminotransferase (AST) above the upper limit of normal within six months before entry into study and a liver biopsy result consistent with the diagnosis of chronic hepatitis C.
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Participants - exclusion criteria
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Patients with:
1. Neutropenia (<1500/ml of neutrophils)
2. Anemia (Hb <12g/dl of hemoglobin)
3. Thrombocytopenia (platelet <90000/ml)
4. Human immunodeficiency virus (HIV) infection
5. Decompensated liver disease
6. Serum creatinine >1.5 times the upper limit of normal
7. Poorly-controlled psychiatric disease
8. Unwilling to receive contraception
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Anticipated start date
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01/01/2004
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Anticipated end date
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30/06/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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500
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Interventions
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All patients who met these criteria randomly chose to be serviced in either of the following two groups:
Group 1 with public health nurse consultation in the outpatient clinic.
Group 2 was offered phone consultation via a health communication center whenever patients needed. Trained healthcare professionals including four nurses and one physician backup at the communication center made a series of structured, scheduled supportive phone calls to patients throughout their treatment period. Additional support was offered to patients to call the healthcare professionals at any time if they have questions. Treating physicians were notified periodically by the health communication center through built-in standardized reminder forms.
All patients were treated with standard therapy. Patients were followed up for 72 weeks. Demographic, laboratory, adverse events, dropout rate and cost data were collected and analyzed.
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Primary outcome measure(s)
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Sustained virologic response (absence of detectable HCV RNA at the end of follow-up with PCR assay)
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Secondary outcome measure(s)
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1. Serum alanine aminotransferase
2. Aspartate aminotransferase
3. Dropout rate (the number of patients who discontinued treatment prematurely or were lost to follow-up)
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Sources of funding
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1. Department of Health (Taiwan) (ref: DOH94-TD-B-111-002)
2. National Health Research Institute (Taiwan) (ref: NHRI-EX95-9106PN)
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Trial website
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Publications
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Contact name
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Dr
Shin-Hai
Tsai
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Address
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Number 250 Wu-Xing Street
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City/town
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TAIPEI
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Zip/Postcode
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110
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Country
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Taiwan
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Sponsor
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Department of Health (Taiwan)
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Address
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Number 100 Aiguo E. Road
Jhongjheng District
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City/town
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Taipei
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Zip/Postcode
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10092
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Country
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Taiwan
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Sponsor website:
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http://www.doh.gov.tw
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Date applied
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03/05/2006
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Last edited
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25/09/2009
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Date ISRCTN assigned
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02/06/2006
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