Assessment of Treatment Adherence and Associated Factors in Chronic HepB Patients Supported by HBVCare (HBVCare)

May 13, 2026 updated by: Institute of Gastroenterology and Hepatology, Vietnam

Assessment of Treatment Adherence and Associated Factors in Chronic Hepatitis B Patients With Supported Management by the HBVCare Application.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 100000
        • Recruiting
        • Hanoi Medical University Hospital
      • Hanoi, Vietnam, 100000
        • Recruiting
        • Institute of Gastroenterology and Hepatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Using HBVCare
Using the mobile phone application HBVCare (with detailed instructions provided during recruitment)
Other: HBVCare Mobile App
Using the smartphone application HBVCare (with detailed instructions provided during recruitment)
No Intervention: Not using HBVCare
Not using the smartphone application HBVCare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with good treatment adherence at 3 months
Time Frame: 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.
3 months after recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Clinical Symptoms
Time Frame: 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.
Baseline and 3 months after recruitment
Mean Usability Metric for User Experience-Lite (UMUX-Lite) Score at 3 Months
Time Frame: 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).
3 months after recruitment
Mean Patient Satisfaction Scores for HBVCare App Features at 3 Months
Time Frame: 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.
3 months after recruitment
Mean Change from Baseline in concentrations of Serum Liver Enzyme Levels (Units per Liter) at 3 Months.
Time Frame: 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).
Baseline and 3 months after recruitment
Mean Change from Baseline in concentrations of Serum Bilirubin Levels (Milligrams per deciliter) at 3 Months
Time Frame: Baseline and 3 months after recruitment

Evaluation of bilirubin processing, including Total Bilirubin and Direct Bilirubin.

Unit of Measure: Milligrams per deciliter (mg/dL)
Baseline and 3 months after recruitment
Mean Change from Baseline in concentration of Serum Albumin (Grams per deciliter) at 3 Months.
Time Frame: 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).
Baseline and 3 months after recruitment
Mean Change from Baseline in Platelet Count (Thousands per microliter) at 3 Months.
Time Frame: 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).
Baseline and 3 months after recruitment
Mean Change from Baseline in International Normalized Ratio (INR) at 3 Months.
Time Frame: 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).
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
Time Frame: 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)
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
Time Frame: 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)
Baseline and 3 months after recruitment
Number of Participants Achieving Hepatitis B envelope Antigen (HBeAg) Seroclearance at 3 Months
Time Frame: 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
Baseline and 3 months after recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Gastroenterology and Hepatology, Vietnam

Collaborators

Hanoi Medical University Hospital, Vietnam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 4, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC2604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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