Prevention of HCC Using Mobile Phone Applications

Hepatitis B Clinical Trial

Official title:

Prevention of HCC Using Mobile Phone Applications: A Disease Management Project Based on CR-HepB Platform

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05094869
• Other study ID #: YYYXYJ-2021-182
• Status: Not yet recruiting
• Start date: November 15, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2021
• Source: Beijing Friendship Hospital
• Contact: Yuanyuan Kong, PhD
• Phone: 86-10-63139364
• Email: kongyy[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis B
• Liver Cirrhosis

Intervention

Behavioral:
• Use of mobile health application
The APP would regularly send messages including the medication reminder, health education knowledge, etc.
• Online interaction
The patients would be able to upload their examination results in the APP and then the doctors will evaluate their disease progression every six months through the APP and guide patients' clinical practice accordingly.
• Self follow-up reminders
The APP would regularly send messages including the follow-up reminder (manually set up by the patient on the APP)
• Intelligent follow-up reminders
The APP would regularly send messages including the follow-up reminder (automatically set up by the APP)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

References & Publications (5)

European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of alcohol-related liver disease. J Hepatol. 2018 Jul;69(1):154-181. doi: 10.1016/j.jhep.2018.03.018. Epub 2018 Apr 5. Review. — View Citation

Marrero JA, Kulik LM, Sirlin CB, Zhu AX, Finn RS, Abecassis MM, Roberts LR, Heimbach JK. Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2018 Aug;68(2):723-750. doi: 10.1002/hep.29913. — View Citation

Singal AG, Pillai A, Tiro J. Early detection, curative treatment, and survival rates for hepatocellular carcinoma surveillance in patients with cirrhosis: a meta-analysis. PLoS Med. 2014 Apr 1;11(4):e1001624. doi: 10.1371/journal.pmed.1001624. eCollection 2014 Apr. — View Citation

Yang B, Zhang B, Xu Y, Wang W, Shen Y, Zhang A, Xu Z. Prospective study of early detection for primary liver cancer. J Cancer Res Clin Oncol. 1997;123(6):357-60. — View Citation

Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24. Erratum in: Lancet. 2020 Jul 4;396(10243):26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient compliance to the standardized semi-annual follow-up	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.	0 to 2 years
Secondary	Applicability of mobile phone application	Applicability of mobile phone application is defined as cumulative minutes of APP use over the study period, which is recorded by APP itself.	0 to 2 years
Secondary	Clinical performance on HCC of the three clinical management modes	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.	0 to 2 years