Chronic Hepatitis B
Conditions
Keywords
Chronic Hepatitis B, Digital health, mobile application, medication adherence
Brief summary
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.
Interventions
OTHERHBVCare Mobile App
Using the smartphone application HBVCare (with detailed instructions provided during recruitment)
Sponsors
Institute of Gastroenterology and Hepatology, Vietnam
Hanoi Medical University Hospital, Vietnam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with good treatment adherence at 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Clinical Symptoms | Baseline and 3 months after recruitment | 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 | 3 months after recruitment | 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 | 3 months after recruitment | 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. | Baseline and 3 months after recruitment | 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). |
| Mean Change from Baseline in concentrations of Serum Bilirubin Levels (Milligrams per deciliter) at 3 Months | Baseline and 3 months after recruitment | Evaluation of bilirubin processing, including Total Bilirubin and Direct Bilirubin. Unit of Measure: Milligrams per deciliter (mg/dL) |
| Mean Change from Baseline in concentration of Serum Albumin (Grams per deciliter) at 3 Months. | Baseline and 3 months after recruitment | Assessment of hepatic synthetic function by measuring the concentration of serum albumin. Unit of Measure: Grams per deciliter (g/dL). |
| Mean Change from Baseline in Platelet Count (Thousands per microliter) at 3 Months. | Baseline and 3 months after recruitment | Measurement of the number of circulating platelets to monitor for portal hypertension or bone marrow suppression. Unit of Measure: Thousands per microliter (10\^3/μL). |
| Mean Change from Baseline in International Normalized Ratio (INR) at 3 Months. | Baseline and 3 months after recruitment | Measurement of a standardized measure of prothrombin time called International Normalized Ratio (INR) to evaluate blood coagulation and liver synthetic function. Unit of Measure: Ratio (Unitless). |
| 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 | Quantitative measurement of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to evaluate the level of viral replication. Unit of Measure: International Units per milliliter (IU/mL) |
| 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 | Evaluation of the change in serum concentration of Hepatitis B Surface Antigen (HBsAg). Unit of Measure: International Units per milliliter (IU/mL) |
| Number of Participants Achieving Hepatitis B envelope Antigen (HBeAg) Seroclearance at 3 Months | Baseline and 3 months after recruitment | Number of participants who transit from Hepatitis B envelope Antigen (HBeAg)-positive at baseline to HBeAg-negative at the 3-month follow-up. Unit of Measure: Number of participants |
Countries
Vietnam
Contacts
CONTACTTrung Quoc Vu
CONTACTHang Viet Dao, MD, PhD
Outcome results
None listed