RecruitingNot ApplicableNCT07540637

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

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


Sponsor

Institute of Gastroenterology and Hepatology, Vietnam

Enrollment

70 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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.

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Interventions

OTHERHBVCare Mobile App

Using the smartphone application HBVCare (with detailed instructions provided during recruitment)


Locations(2)

Hanoi Medical University Hospital

Hanoi, Vietnam

Institute of Gastroenterology and Hepatology

Hanoi, Vietnam

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NCT07540637


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