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Recruiting NCT07540637

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

No phase Interventional Chronic Hepatitis B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HBVCare Mobile App.
Who it may be relevant to
Registry conditions: Chronic Hepatitis B. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other HBVCare Mobile App
    Using the smartphone application HBVCare (with detailed instructions provided during recruitment)

Primary outcome measures

  • Proportion of patients with good treatment adherence at 3 months [Time frame: 3 months after recruitment]
Secondary outcome measures (11)
  • Changes in Clinical Symptoms [Time frame: 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]
  • Mean Patient Satisfaction Scores for HBVCare App Features at 3 Months [Time frame: 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]
  • Mean Change from Baseline in concentrations of Serum Bilirubin Levels (Milligrams per deciliter) at 3 Months [Time frame: 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]
  • Mean Change from Baseline in Platelet Count (Thousands per microliter) at 3 Months. [Time frame: 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]
  • 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]
  • 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]
  • Number of Participants Achieving Hepatitis B envelope Antigen (HBeAg) Seroclearance at 3 Months [Time frame: Baseline and 3 months after recruitment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Vietnam · 2 centers
  • Hanoi Medical University Hospital — Hanoi
  • Institute of Gastroenterology and Hepatology — Hanoi

Identifiers

NCT: NCT07540637 · HC2604

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗