Prevention of HCC Using Mobile Phone Applications

• Conditions: Liver Cirrhosis; Hepatitis B
• Interventions: Behavioral: Use of mobile health application; Behavioral: Self follow-up reminders; Behavioral: Online interaction; Behavioral: Intelligent follow-up reminders

• Registration Number: NCT05094869
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-22
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-25
• Last Update Submitted: 2021-10-25
• Study First Posted: 2021-10-26
• Last Update Posted: 2021-10-26
• Study Start: 2021-11-15
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8000

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

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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;

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
APP self-management group	Self follow-up reminders	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.
APP self-management group	Use of mobile health application	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.
APP intelligent-management group	Online interaction	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.
APP intelligent-management group	Intelligent follow-up reminders	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.
APP intelligent-management group	Use of mobile health application	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.

Primary Outcome Measures

Name	Time	Method
Patient compliance to the standardized semi-annual follow-up	0 to 2 years	Total follow-up times with the three clinical management modes. The event of follow-up is defined as self-reported clinic visit for liver cirrhosis assessment on the mobile phone application by patients.

Secondary Outcome Measures

Name	Time	Method
Applicability of mobile phone application	0 to 2 years	Applicability of mobile phone application is defined as cumulative minutes of APP use over the study period, which is recorded by APP itself.
Clinical performance on HCC of the three clinical management modes	0 to 2 years	Clinical performance on HCC is defined as the proportion of early stage HCC among all detected HCC. The event of HCC is measured with self-reported HCC and the stage on the mobile phone application by patients.