Clinical trial NCT05094869: Prevention of HCC Using Mobile Phone Applications
Official title: Prevention of HCC Using Mobile Phone Applications: A Disease Management Project Based on CR-HepB Platform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Hepatitis B
Keywords: Compensatory hepatitis B cirrhosis
Health management
Mobile health application
Compliance
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. 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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Patient compliance to the standardized semi-annual follow-up
timeFrame: 0 to 2 years
Secondary outcomes:
measure: Applicability of mobile phone application
timeFrame: 0 to 2 years
measure: Clinical performance on HCC of the three clinical management modes
timeFrame: 0 to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Friendship Hospital
name: Jidong Jia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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