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

Recruiting · NCT07540637 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Gastroenterology and Hepatology, Vietnam

View the official record on ClinicalTrials.gov →

Hepatitis B

Interventions studied

HBVCare Mobile App

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

2 locations listed.

Hanoi Medical University Hospital - Hanoi, Vietnam
Institute of Gastroenterology and Hepatology - Hanoi, Vietnam

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →