Quality of Life and Health Utility of Patients With CHB Infections
NCT ID: NCT03329820
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
589 participants
OBSERVATIONAL
2006-11-30
2009-12-31
Brief Summary
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The following hypotheses will be tested:
1. Patients with chronic hepatitis B virus (HBV) have poorer health-related quality of life (HRQOL) than the general population;
2. Patients with more severe stages of chronic HB infections have lower health related quality of life and health utility values;
3. Anti-viral treatment can improve the HRQOL and health utility for patients with CHB infections;
4. The cost-effectiveness of different treatments for chronic HBV infections can be directly compared in terms of cost/QALY gained.
Detailed Description
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Interventions: Each subject in the cross-sectional study will be interviewed. Five strategies for management of CHB infections: 1) No treatment, 2) Interferon monotherapy, 3) lamivudine monotherapy, 4) adefovir and 5) combined treatment of lamivudine and adefovir, will be tested in the biomathematical modelling,.
Main Outcome Measures: Health-related quality of life measured by the SF-36, preference-based health utilities measured by the SF-6D. quality adjusted life years (QALYs) and cost of different treatment strategies for HBV infection.
Hypothesis: HRQOL and health utilities of patients with different illness stages, and the QALYs gained and cost-effectiveness of different therapeutic strategies will be established. The results will provide information on the health burden of CHB infections, and evidence on the cost-effectiveness of anti-viral treatments in preventing disease progression can be directly compared.
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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1 Uncomplicated CHB
Patients with chronic CHB infections but normal liver function and without cirrhosis or hepatocellular carcinoma
No interventions assigned to this group
2 CHB with impaired liver function (LF) or CC w/o tx
CHB with impaired liver function or compensated cirrhosis, not on anti-viral treatment
No interventions assigned to this group
3 CHB with impaired LF or CC with tx
CHB with impaired liver function or compensated cirrhosis, on anti-viral treatment.
No interventions assigned to this group
4 Decompensated cirrhosis
Patients with CHB infection and cirrhosis complicated by one or more of the following: variceal bleeding, hepatic encephalopathy or ascites.
No interventions assigned to this group
5 Hepatocellular carcinoma
Patients with confirmed diagnosis of hepatocellular carcinoma
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Are 18 years and above in age;
2. Are known to be HBsAg positive for more than six months;
3. Can be classified into one of the following sages of liver diseases:
(i) Uncomplicated CHB: Patients with chronic CHB infections but normal liver function and without cirrhosis or HCC.
(ii) CHB with impaired liver function or compensated cirrhosis, not on anti-viral treatment.
(iii) CHB with impaired liver function or compensated cirrhosis, on anti-viral treatment.
(iv) Decompensated cirrhosis: Patients with CHB infection and cirrhosis complicated by one or more of the following: variceal bleeding, hepatic encephalopathy or ascites.
(v) Hepatocellular Carcinoma: Patients with confirmed diagnosis of HCC
d. Have given written consent to take part in the study.
Exclusion Criteria
1. Unable to understand and communicate in Chinese Language;
2. Known cognitive impairment;
3. Diagnosed end-stage non-hepatitis B related chronic illness such as terminal cancer;
4. Patients currently abusing alcohol (\>30 units/week) or illegal drugs;
5. Co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV);
6. Post-liver transplant;
7. Refuse to give consent.
18 Years
ALL
No
Sponsors
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Hospital Authority, Hong Kong
OTHER_GOV
The University of Hong Kong
OTHER
Responsible Party
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Professor Cindy L.K. Lam
Head and Clinical Professor
Locations
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Two Regional Hospitals
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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HKCTR-151
Identifier Type: -
Identifier Source: org_study_id