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Идёт набор NCT07540637

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

Без фазы С лечением Chronic Hepatitis B

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: HBVCare Mobile App.
Кому может быть актуально
Состояния в реестре: Chronic Hepatitis B. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Вьетнам
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

  • Proportion of patients with good treatment adherence at 3 months [Срок оценки: 3 months after recruitment]
Вторичные конечные точки (11)
  • Changes in Clinical Symptoms [Срок оценки: Baseline and 3 months after recruitment]
  • Mean Usability Metric for User Experience-Lite (UMUX-Lite) Score at 3 Months [Срок оценки: 3 months after recruitment]
  • Mean Patient Satisfaction Scores for HBVCare App Features at 3 Months [Срок оценки: 3 months after recruitment]
  • Mean Change from Baseline in concentrations of Serum Liver Enzyme Levels (Units per Liter) at 3 Months. [Срок оценки: Baseline and 3 months after recruitment]
  • Mean Change from Baseline in concentrations of Serum Bilirubin Levels (Milligrams per deciliter) at 3 Months [Срок оценки: Baseline and 3 months after recruitment]
  • Mean Change from Baseline in concentration of Serum Albumin (Grams per deciliter) at 3 Months. [Срок оценки: Baseline and 3 months after recruitment]
  • Mean Change from Baseline in Platelet Count (Thousands per microliter) at 3 Months. [Срок оценки: Baseline and 3 months after recruitment]
  • Mean Change from Baseline in International Normalized Ratio (INR) at 3 Months. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline and 3 months after recruitment]
  • Number of Participants Achieving Hepatitis B envelope Antigen (HBeAg) Seroclearance at 3 Months [Срок оценки: Baseline and 3 months after recruitment]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Вьетнам · 2 центра
  • Hanoi Medical University Hospital — Hanoi
  • Institute of Gastroenterology and Hepatology — Hanoi

Идентификаторы

NCT: NCT07540637 · HC2604

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗