Prevention of HCC Using Mobile Phone Applications

Capital Medical University

Status: Unknown

Conditions: Liver Cirrhosis; Hepatitis B

Treatments: Behavioral: Intelligent follow-up reminders; Behavioral: Online interaction; Behavioral: Self follow-up reminders; Behavioral: Use of mobile health application

Study type: Observational

Funder types: Other

Identifiers

NCT05094869

YYYXYJ-2021-182

Details and patient eligibility

About

This prospective cohort study is initiated to evaluate the compliance improvement to the standardized follow-up and clinical management in the population of compensatory hepatitis B cirrhosis with a mobile health application (APP). Patients were enrolled and divided into APP self-management group (APP only ) and APP intelligent-management group (APP and online interaction). The compliance to the standardized follow-up and clinical management (every six months) under the two clinical management modes would be evaluated and compared with the history data extracted from the platform of China Registry of Hepatitis B (CR-Hep B).

Full description

Standardized follow-up and clinical management in the population of compensatory hepatitis B cirrhosis is important in the prevention of liver cancer. In the clinical practice, follow-up every six months are usually recommended. This prospective cohort study is initiated to evaluate the compliance improvement to the standardized follow-up and clinical management with a health management application (APP). 4000 patients who have registered on the platform of China Registry of Hepatitis B (CR-Hep B) and been diagnosed as compensatory hepatitis B cirrhosis would be recruited in the study. They were divided into two groups according to whether they use the APP and whether there is online interaction between doctors and patients:

1. APP self-management group (APP only, N=1000): Patients would register on the APP and visit the clinics according to the routine practice and guidelines. During the study, the APP would regularly send messages including the follow-up reminder (manually set up by the patients on the APP), medication reminder, health education knowledge, etc.
2. APP intelligent-management group (APP and online interaction, N=3000): Patients would register on the APP and visit the clinics according to the routine practice and guidelines. During the study, the APP would regularly send messages including the follow-up reminder (automatically set up by the APP), medication reminder, health education knowledge, etc. The doctors will evaluate their disease progression every six months through the APP and guide patients' clinical practice accordingly.

Patients in these two groups would be followed up for 2 years after enrollment. Besides, history data of another 4000 Patients who have been on the platform of China Registry of Hepatitis B (CR-Hep B) and been diagnosed as compensatory hepatitis B cirrhosis would be extracted and serve as the control group (No APP and No online interaction, N=4000).

The compliance to the standardized follow-up and clinical management (every six months) under the three clinical management modes would be evaluated.

Enrollment: 8,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Registered on the CR-HepB platform

• Requiring or receiving antiviral therapy using nucleoside (acid) analogues (recommended as the first-line therapy in the 2019 Chinese Guidelines for Chronic Hepatitis B Prevention and Treatment )

• Diagnosed as compensatory hepatitis B cirrhosis, with the diagnostic criteria fitting any of the following criteria:

  1. Diagnosis of Liver cirrhosis by histology;
  2. Varicose veins in Esophageal and/or gastric fundus indicated by endoscopy;
  3. Diagnosis of Liver cirrhosis by Imaging examination (abdominal ultrasound, CT, MRI) ;
  4. Liver elasticity measurement >12.0 kpa (ALT<5×ULN)
  5. Platelet PLT lower than the lower limit of normal value, and Serum albumin (ALB) lower than 35 g/L or international standardized ratio (INR) >1.3.

• Completing the informed consent form

Exclusion criteria

• With any decompensated cirrhosis events, such as esophagogastric variceal rupture and bleeding, ascites, and hepatic encephalopathy;
• With any malignant tumor;
• With serious illness on any vital organs and systems, including heart, lungs, kidneys, and blood;
• Unsuitable for participating the study deemed by researchers;

Trial design

8,000 participants in 3 patient groups

APP self-management group

Description:

Patients would register on the APP and visit the clinics according to the routine practice and guidelines. During the study, the APP would regularly send messages including the follow-up reminder (manually set up by the patients on the APP), medication reminder, health education knowledge, etc.

Treatment:

Behavioral: Use of mobile health application

Behavioral: Self follow-up reminders

APP intelligent-management group

Description:

Patients would register on the APP and visit the clinics according to the routine practice and guidelines. During the study, the APP would regularly send messages including the follow-up reminder (automatically set up by the APP), medication reminder, health education knowledge, etc. The doctors will evaluate their disease progression every six months through the APP and guide patients' clinical practice accordingly.

Treatment:

Behavioral: Use of mobile health application

Behavioral: Online interaction

Behavioral: Intelligent follow-up reminders

Control group

Description:

History data of another 4000 Patients who have been on the platform of China Registry of Hepatitis B (CR-Hep B) and been diagnosed as compensatory hepatitis B cirrhosis would be extracted and serve as the control group (No APP, no follow-up reminders, no online interaction).