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.
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.
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.
Parallel
HBVCare Mobile App
Other interventionUsing the smartphone application HBVCare (with detailed instructions provided during recruitment)
Proportion of patients with good treatment adherence at 3 months
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.
Changes in Clinical Symptoms
Assessment of 8 subjective symptoms associated with chronic Hepatitis B (fatigue / tiredness, Skin or mucosal hemorrhage, loss of appetite, ascites, nausea / vomiting, pain or discomfort in the liver area, jaundice / discolored urine, peripheral edema). Symptom progression was evaluated over a 3-month follow-up period based on patient-reported outcomes: improvement, no change, worsening, new onset, or absence of symptoms.
Mean Usability Metric for User Experience-Lite (UMUX-Lite) Score at 3 Months
Evaluation of the overall perceived usability and usefulness of the HBVCare digital platform. The Usability Metric for User Experience-Lite (UMUX-Lite) consists of two items (the app is easy to use, the app meets my requirements) measured on a 7-point Likert scale (total of 14 points, higher scores indicate better perceived usability and a more positive user experience).
Mean Patient Satisfaction Scores for HBVCare App Features at 3 Months
Assessment of user satisfaction with 5 specific app features: clinical data storage, medication/follow-up reminders, health education, symptom/adherence surveys, and reporting graphs. Each feature is rated on a 5-point Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied). Higher scores indicate higher levels of satisfaction with the specific feature.
Mean Change from Baseline in concentrations of Serum Liver Enzyme Levels (Units per Liter) at 3 Months.
Liver function test results for evaluating hepatic inflammation, including concentrations of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Gamma-glutamyl Transferase (GGT). Unit of Measure: Units per Liter (U/L).
Click on the lead sponsor to view all of their trials.
Institute of Gastroenterology and Hepatology, Vietnam
Lead sponsor
Hanoi Medical University Hospital, Vietnam
Collaborator
