Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16,300
- 试验地点
- 3
- 主要终点
- Referral Rate
研究概览
简要总结
Since 2022, the Third Affiliated Hospital of Sun Yat-sen University has initiated the "Hot Wave Project", a comprehensive hepatitis B infection prevention and management system encompassing patient education, screening, referral, treatment, and follow-up. In 2024, this system was expanded to the Sixth Affiliated Hospital and the Fifth Affiliated Hospital of Sun Yat-sen University, transitioning into a multicenter, hospital-based cohort study on hepatitis B management.The primary objective of this study is to increase the referral rate of HBsAg-positive patients in non-hepatology/non-infectious disease departments to 50%. The secondary objective is to improve the treatment rate of hepatitis B infected patients in non-hepatology/non-infectious disease departments, particularly focusing on the diagnosed but untreated (DBU) population. Furthermore, this study aims to analyze the cost-effectiveness and clinical benefits of in-hospital hepatitis B screening and management strategies.In 2025, a Patient-Reported Outcomes (PRO) sub-study was added to the project to evaluate the impact of antiviral therapy on the Health-Related Quality of Life among a cohort of treatment-naïve patients with chronic hepatitis B.
详细描述
The "Hot wave Project" aims to establish a multicenter management cohort for HBsAg-positive patients within hospitals. Led by infectious disease specialists, the program conducts regular hepatitis B training sessions for hospital staff to enhance their understanding of HBV prevention and control. This initiative seeks to increase HBsAg screening rates overall and encourage patients from non-infectious disease departments to seek referrals to specialized care.
For all paper reports containing HBsAg test results, a remark is added stating: "HBsAg (+) - Recommended to visit the Hepatitis B Health Clinic in the Infectious Disease Department." Positive HBsAg results are automatically extracted by the information system and sent to a dedicated computer in the Hepatitis B Health Clinic, enabling centralized digital patient management.
Additionally, the Infectious Disease Department appoints a "Hepatitis B Specialist Assistant" responsible for reviewing HBsAg screening results, notifying HBsAg-positive patients or their attending physicians, and establishing follow-up records for all patients. A "Hepatitis B Health Clinic" is also set up within the department, managed by a specialized medical team that handles the diagnosis, treatment, and education for referred chronic hepatitis B patients.
Building upon this comprehensive management cohort, the project was expanded in 2025 to include a prospective Patient-Reported Outcomes (PRO) sub-study. This sub-study is designed to evaluate the longitudinal impact of antiviral therapy on the Health-Related Quality of Life among treatment-naïve patients with chronic hepatitis B. Utilizing the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL), the study assesses patients across four key dimensions-physical symptoms, emotional symptoms, beliefs, and social stigma-at baseline, 24 weeks, and 48 weeks post-treatment. By integrating PROs into clinical practice, the Hot wave Project goes beyond traditional biological endpoints to understand the challenges and benefits of HBV treatment from the patient's perspective, ultimately fostering a more patient-centered approach to chronic disease management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg-positive patients attending non-infectious disease/hepatology departments at three study centers.
- •Additional inclusion criteria for the PRO sub-study:
- •Age ≥ 18 years;
- •Treatment-naïve HBV-infected patients;
- •Meet the treatment criteria according to the "Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2022 version);
- •Be able to understand the study content, willing to participate, and sign the informed consent;
- •Have the ability to complete questionnaires independently or with assistance.
排除标准
- •HBsAg-positive patients already under regular follow-up in infectious disease/hepatology clinics.
- •Chronic HBV patients on regular antiviral treatment.
- •Additional exclusion criteria for the PRO sub-study:
- •History of chronic liver diseases other than chronic HBV infection, including but not limited to: alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, etc. Co-infection with HCV, HDV, or HIV. Presence of other severe conditions that may affect HRQoL (such as severe cardiovascular and cerebrovascular diseases, uncontrolled mental illnesses, malignant tumors, etc.);
- •Pregnant or lactating women;
- •Use of pegylated interferon during the study;
- •Failure to complete all follow-up visits;
- •Other conditions that the investigator deems inappropriate for participation.
研究组 & 干预措施
In-Hospital HBV Linkage-to-Care Cohort
This cohort consists of HBsAg-positive patients identified in non-hepatology and non-infectious disease departments across three participating medical centers from. An estimated 16,000 patients will be included in this prospective management cohort.Participants in this cohort are managed under the multidisciplinary "Hot wave Project 2.0" workflow. Positive HBsAg results are automatically captured by the hospital information system and flagged with cautionary remarks. Full-time project nurses proactively contact these patients via telephone, providing them with patient education materials, a quick medical consultation card, and encouraging them to visit the dedicated "Hepatitis B Health Clinic" within 2 weeks.
干预措施: Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department. (Other)
Antiviral Therapy PRO Cohort
This cohort consists of adult (≥ 18 years), treatment-naïve patients with chronic hepatitis B enrolled from the "Hot wave Project 2.0" management cohort. Eligible patients must meet the indications for antiviral treatment according to the 2022 Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B.Participants in this observational cohort will initiate standard-of-care antiviral therapy as prescribed by their physicians. Throughout the study, their Health-Related Quality of Life will be longitudinally assessed using the localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). PRO assessments, alongside routine clinical parameters will be systematically collected at baseline (Week 0), and at 24 weeks and 48 weeks post-treatment. The target enrollment for this cohort is 300 participants.
干预措施: Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B. (Other)
结局指标
主要结局
Referral Rate
时间窗: 2 weeks
Referral rate of HBsAg-positive patients in non-infectious disease departments = Number of HBsAg-positive patients referred to infectious disease departments / Total number of HBsAg-positive patients in non-infectious disease departments.
Changes in Health-Related Quality of Life assessed by the CHBQOL Scale
时间窗: Baseline (Week 0), week 24, and week 48
Patient-Reported Outcomes (PROs) and HRQoL are evaluated using the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). The CHBQOL comprises 23 items categorized into four dimensions: physical symptoms, emotional symptoms, beliefs, and social stigma. This measure will calculate the longitudinal changes in both the total CHBQOL score and its dimension-specific sub-scores before and after initiating standard antiviral therapy. The objective is to quantify the impact of antiviral treatment on the quality of life in treatment-naïve CHB patients.
Referral rate
时间窗: 2 weeks
Referral rate of HBsAg-positive patients in non-infectious disease departments = Number of HBsAg-positive patients referred to infectious disease departments / Total number of HBsAg-positive patients in non-infectious disease departments.
次要结局
- Antiviral Treatment Rate(2 weeks)
- Incremental Cost-Effectiveness Ratio(3 years)
- Correlation Between HRQoL Changes and Clinical Responses(Baseline (Week 0), Week 24, and Week 48)
- Predictive Factors Affecting HRQoL Changes(Baseline (Week 0), Week 24, and Week 48)
- Antiviral treatment rate(2 weeks)
- The cost-effectiveness of in-hospital HBV screening and management strategies(5 years)
研究者
Liang Peng
Professor
Third Affiliated Hospital, Sun Yat-Sen University