Prevention of HCC Using Mobile Phone Applications

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis; Hepatitis B
• Intervention / Treatment: Behavioral: Use of mobile health application; Behavioral: Self follow-up reminders; Behavioral: Online interaction; Behavioral: Intelligent follow-up reminders

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 Type: Observational
• Enrollment (Anticipated): 8000

Contacts and Locations

• Study Contact: Name: Yuanyuan Kong, PhD; Phone Number: 86-10-63139364; Email: kongyy@ccmu.edu.cn
• Study Contact Backup: Name: Jidong Jia, MD, PhD; Phone Number: 86-13501378269; Email: jia_jd@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
APP self-management group; 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.	Behavioral: Use of mobile health application; The APP would regularly send messages including the medication reminder, health education knowledge, etc.; Behavioral: Self follow-up reminders; The APP would regularly send messages including the follow-up reminder (manually set up by the patient on the APP)
APP intelligent-management group; 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.	Behavioral: Use of mobile health application; The APP would regularly send messages including the medication reminder, health education knowledge, etc.; Behavioral: 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.; Behavioral: Intelligent follow-up reminders; The APP would regularly send messages including the follow-up reminder (automatically set up by the APP)
Control group; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Jidong Jia, MD, PhD, Beijing Friendship Hospital

Publications and helpful links

General Publications

• 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.
• 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. No abstract available.
• 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. doi: 10.1007/BF01438313.
• 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.
• 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. No abstract available.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Compliance; Health management; Mobile health application; Compensatory hepatitis B cirrhosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Fibrosis; Hepatitis B; Hepatitis; Liver Cirrhosis
• Other Study ID Numbers: YYYXYJ-2021-182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No