Assessment of Treatment Adherence and Associated Factors in Chronic Hepatitis B Patients With Supported Management by the HBVCare Application.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Proportion of patients with good treatment adherence at 3 months
研究概览
简要总结
Adherence to chronic Hepatitis B (HBV) treatment and regular follow-up visits is essential for preventing dangerous complications, yet adherence rates in Vietnam remain low due to barriers in patient awareness and geographic conditions. Digital health solutions, particularly mobile applications, have shown potential as tools for supporting patients in proactive disease management. The HBVCare mobile application was developed to provide features such as medication reminders, storage of lab results, and health education to improve treatment adherence and clinical outcomes. The investigators are conducting a multicenter, randomized controlled trial at Hoang Long Clinic and Hanoi Medical University Hospital to evaluate the effectiveness of HBVCare. Patients are randomized into either a control group receiving standard care and an intervention group using the HBVCare app, with patient adherence and related factors assessed after three months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age ≥ 18 years.
- •Diagnosis of Chronic Hepatitis B (CHB): HBsAg (+) and/or HBV DNA positive for ≥ 6 months; Or HBsAg positive and anti-HBc IgM negative.
- •Smartphone ownership (iOS or Android) with an active internet connection and the ability to install the HBVCare application.
- •Sufficient literacy to read and understand Vietnamese and respond to study questions.
- •Provision of informed consent to participate in the study.
排除标准
- •Mental health disorders, cognitive impairment, or difficulties in communication and mobile application usage.
- •Severe comorbid chronic conditions, such as heart failure, kidney failure, or respiratory failure.
- •Presence of severe complications, including gastrointestinal bleeding, liver cancer, hepatic encephalopathy, or acute liver failure.
研究组 & 干预措施
Using HBVCare
Using the mobile phone application HBVCare (with detailed instructions provided during recruitment)
干预措施: HBVCare Mobile App (Other)
Not using HBVCare
Not using the smartphone application HBVCare
结局指标
主要结局
Proportion of patients with good treatment adherence at 3 months
时间窗: 3 months after recruitment
Patients achieved a high level of adherence to antiviral medication (25 points on MARS-5 score) and follow-up schedules (attend the clinical follow-up within 1 week of the pre-specified schedule) as recorded through the HBVCare application.
次要结局
- Changes in Clinical Symptoms(Baseline and 3 months after recruitment)
- Mean Usability Metric for User Experience-Lite (UMUX-Lite) Score at 3 Months(3 months after recruitment)
- Mean Patient Satisfaction Scores for HBVCare App Features at 3 Months(3 months after recruitment)
- Mean Change from Baseline in concentrations of Serum Liver Enzyme Levels (Units per Liter) at 3 Months.(Baseline and 3 months after recruitment)
- Mean Change from Baseline in concentrations of Serum Bilirubin Levels (Milligrams per deciliter) at 3 Months(Baseline and 3 months after recruitment)
- Mean Change from Baseline in concentration of Serum Albumin (Grams per deciliter) at 3 Months.(Baseline and 3 months after recruitment)
- Mean Change from Baseline in Platelet Count (Thousands per microliter) at 3 Months.(Baseline and 3 months after recruitment)
- Mean Change from Baseline in International Normalized Ratio (INR) at 3 Months.(Baseline and 3 months after recruitment)
- Mean Change from Baseline in Serum Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Viral Load in International Units per milliliter at 3 Months(Baseline and 3 months after recruitment)
- Mean Change from Baseline in Quantitative Hepatitis B Surface Antigen (qHBsAg) in International Units per milliliter (IU/mL) at 3 Months(Baseline and 3 months after recruitment)
- Number of Participants Achieving Hepatitis B envelope Antigen (HBeAg) Seroclearance at 3 Months(Baseline and 3 months after recruitment)