Bio-psycho-social Drivers of Disparities in Liver Disease Progression Among Korean Americans With Hepatitis B Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 2
- 主要终点
- Change Liver disease severity
研究概览
简要总结
This study explores how psychosocial factors (e.g., chronic stress, depression) may lead to liver disease progression such as liver cirrhosis or liver cancer among Korean American chronic hepatitis B infection patients. Gathering health information over time from Korean Americans with chronic hepatitis B infection may help doctors find better methods of treatment and on-going care.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the prevalence of chronic hepatitis B (CHB) phenotype and liver disease severity at enrollment visit, and model how multiple social-environmental, psychosocial, behavioral, clinical and biological attributes are associated with variation in CHB phenotype and disease severity.
II. To identify how these same attributes are associated with disease progression over time.
SECONDARY OBJECTIVE:
I. To examine the moderating effects of these multi-level factors on the relationship between liver disease progression and adverse liver disease outcome (e.g., hepatocellular carcinoma [HCC]), as well as mediating effects of liver disease progression on the relationship between psychosocial factors and liver cancer or death.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures and be available for the duration of the study
- •Korean-American male or female, age over 18 and older
- •CHB Patients who have lab and medical record data (including hepatitis B virus [HBV] deoxyribonucleic acid [DNA] viral load, hepatitis B virus e Antigen [HBeAg] status, and liver enzyme values) exist from 2015 or before
排除标准
- •Patients who have received a diagnosis of HCC, although they may have been diagnosed with cirrhosis
- •Patients who have been diagnosed with other viral infections (hepatitis C virus [HCV], human immunodeficiency virus [HIV], etc.)
- •Patients who have total baldness
研究组 & 干预措施
Observational (interview, biospecimen collection)
Patients participate in interviews over 20-40 minutes and undergo collection of hair samples at baseline and 18-24 months. Patients' medical records are also reviewed.
干预措施: Biospecimen Collection (Procedure)
Observational (interview, biospecimen collection)
Patients participate in interviews over 20-40 minutes and undergo collection of hair samples at baseline and 18-24 months. Patients' medical records are also reviewed.
干预措施: Electronic Health Record Review (Other)
Observational (interview, biospecimen collection)
Patients participate in interviews over 20-40 minutes and undergo collection of hair samples at baseline and 18-24 months. Patients' medical records are also reviewed.
干预措施: Interview (Other)
结局指标
主要结局
Change Liver disease severity
时间窗: At end of treatment
Will be estimated using fibrosis 4 (FIB-4) (a parameter calculated using alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\] values, platelet count and age) and APRI (AST to platelet ratios).
Change Chronic hepatitis B (CHB) phenotype
时间窗: At start of treatment
Categorized as follows: 1) immune tolerant, 2) immune active with hepatitis B virus e antigen (HBeAg)(+), 3) immune active with HBeAg(-), and 4) inactive carrier, with patients not fitting into one of these four phenotypes classified as 5) indeterminant. Phenotype at study enrollment will be calculated
次要结局
- Change in hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels(Baseline to 10 years)