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

NCT07540637 | Not Yet Recruiting

• 1 other identifier: HC2604
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Hepatitis B

Keywords

Chronic Hepatitis B; Digital health; mobile application; medication adherence

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with good treatment adherence at 3 months

  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 Outcomes (11)

• Changes in Clinical Symptoms

  Baseline and 3 months after recruitment

• Mean Usability Metric for User Experience-Lite (UMUX-Lite) Score at 3 Months

  3 months after recruitment

• Mean Patient Satisfaction Scores for HBVCare App Features at 3 Months

  3 months after recruitment

• Mean Change from Baseline in concentrations of Serum Liver Enzyme Levels (Units per Liter) at 3 Months.

  Baseline and 3 months after recruitment

• Mean Change from Baseline in concentrations of Serum Bilirubin Levels (Milligrams per deciliter) at 3 Months

  Baseline and 3 months after recruitment

Study Arms (2)

Using HBVCare

EXPERIMENTAL

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

Other: HBVCare Mobile App

Not using HBVCare

NO INTERVENTION

Not using the smartphone application HBVCare

Interventions

HBVCare Mobile App OTHER

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

Using HBVCare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Gastroenterology and Hepatology, Vietnam: lead
• Hanoi Medical University Hospital, Vietnam: collaborator

Study Sites (2)

Hanoi Medical University Hospital

Hanoi, 100000, Vietnam

Location

Institute of Gastroenterology and Hepatology

Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Medication Adherence

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Trung Quoc Vu

CONTACT

+84796262002; vuquoctrung0305@gmail.com

Hang Viet Dao, MD, PhD

CONTACT

+84987988075; hangdao.fsh@gmail.com; daoviethang@hmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)